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Insomnia is an adverse cancer outcome impacting mood, pain, quality of life, and mortality in cancer patients. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment for diverse psychophysiological disorders, including pain and insomnia. Primarily studied in breast cancer, there is limited research on CBT within gynecology oncology. This study examined CBT effects on subjective and behavioral sleep outcomes: Sleep Efficiency (SE), Sleep Quality (SQ), Total Wake Time (TWT), Sleep Onset Latency (SOL), and Wake After Sleep Onset (WASO). Thirty-five women with insomnia status/post-surgery for gynecologic cancer were randomized to CBT for insomnia and pain (CBTi.p., N = 18) or Psychoeducation (N = 17). Sleep was assessed via sleep diaries and wrist-worn actigraphy at baseline (T1), post-intervention (T2), and two-month follow-up (T3). Intent-to-treat analyses utilizing mixed linear modeling examined longitudinal group differences on sleep controlling for age and advanced cancer. All participants demonstrated improved (1) subjective SE (0.5, p < .01), SOL (-1.2, p < .01), TWT (-1.2, p < .01), and (2) behavioral SE (0.1, p = .02), TWT (-1.2, p = .03), WASO (-0.8, p < .01) across time. Group-level time trends were indicative of higher subjective SE (6.8, p = .02), lower TWT (-40.3, p = .01), and lower SOL (-13.0, p = .05) in CBTi.p. compared to Psychoeducation. Supplemental analyses examining clinical significance and acute treatment effects demonstrated clinical improvements in SE (T1), TWT (T2, T3), and SOL (T3). Remaining effects were not significant. Despite lacking power to detect interaction effects, CBTi.p. clinically improved sleep in women with gynecologic cancers and insomnia during the active treatment phase. Future research will focus on developing larger trials within underserved populations.
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Terapia Cognitivo-Comportamental , Neoplasias dos Genitais Femininos , Distúrbios do Início e da Manutenção do Sono , Feminino , Neoplasias dos Genitais Femininos/complicações , Neoplasias dos Genitais Femininos/terapia , Humanos , Dor , Qualidade de Vida , Sono , Distúrbios do Início e da Manutenção do Sono/complicações , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
OBJECTIVE: Behavioral treatments for insomnia improve sleep in older adults, but research documenting their effects on cognitive performance is mixed. We explored whether a brief behavioral treatment for insomnia (BBTi) impacts daily associations between sleep parameters and next day cognition. METHODS: Sixty-two older adults (Mage = 69.45 years, SD = 7.71) with insomnia completed either 4 weeks of BBTi or self-monitoring control (SMC). At baseline, post-treatment, and 3 month follow-up, participants completed 14 days of diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series). At each time period, associations between sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2nd Edition scores), were examined through multilevel modeling. RESULTS: At post-treatment, we observed an interactive fixed effect of treatment condition (i.e., BBTi/SMC) and TST on daily SDMT and letter series performance. For BBTi, longer TST was associated with better letter series performance, and did not predict SDMT performance. For SMC, longer TST was associated with worse SDMT, and was not associated with letter series performance. Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment. Associations were not maintained at follow-up. CONCLUSIONS: Sleep duration may play an important role in BBTi-related improvements in daily higher order cognition. Maintenance of these associations may be facilitated by booster sessions following post-treatment. CLINICAL TRIAL IDENTIFIER: NCT02967185.
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Terapia Comportamental/métodos , Cognição/fisiologia , Distúrbios do Início e da Manutenção do Sono/terapia , Idoso , Feminino , Humanos , Masculino , Autorrelato , Resultado do TratamentoRESUMO
Clock gene dysregulation has been shown to underlie various sleep disorders and may lead to negative cardio-metabolic outcomes. However, the association between sleep apnea (SA) and core clock gene expression is unclear. We performed a cross-sectional analysis of 49 Veterans enrolled in a study of SA outcomes in veterans with chronic kidney disease, not selected for SA or sleep complaints. All participants underwent full polysomnography and next morning whole blood collection for clock gene expression. We defined SA as an apnea-hypopnea index ≥15 events/h; nocturnal hypoxemia(NH) was defined as ≥10% of total sleep time spent at <90% oxygen saturation. We used quantitative real-time PCR to compare the relative gene expression of clock genes between those with and without SA or NH. Clock genes studied were Bmal1, Ck1δ, Ck1ε, Clock, Cry1, Cry2, NPAS2, Per1, Per2, Per3, Rev-Erb-α, RORα, and Timeless. Our cohort was 90% male, mean age was 71 yr (SD 11), mean body mass index was 30 kg/m2 (SD 5); 41% had SA, and 27% had NH. Compared with those without SA, Per3 expression was reduced by 35% in SA ( P = 0.027). Compared with those without NH, NPAS2, Per1, and Rev-Erb-α expression was reduced in NH (50.4%, P = 0.027; 28.7%, P = 0.014; 31%, P = 0.040, respectively). There was no statistical difference in expression of the remaining clock genes by SA or NH status. Our findings suggest that SA or related NH and clock gene expression may be interrelated. Future study of 24 h clock gene expression in SA is needed to establish the role of clock gene regulation on the pathway between SA and cardio-metabolic outcomes.
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Proteínas CLOCK/genética , Expressão Gênica , Síndromes da Apneia do Sono/genética , Veteranos , Idoso , Idoso de 80 Anos ou mais , Ritmo Circadiano/genética , Estudos de Coortes , Estudos Transversais , Feminino , Regulação da Expressão Gênica , Humanos , Hipóxia/genética , Masculino , Pessoa de Meia-Idade , Reação em Cadeia da Polimerase em Tempo RealRESUMO
Sleep diary and actigraphy assessments of insomnia symptoms in patients with fibromyalgia (FM) are often discrepant. We examined whether opioid dose and age interact in predicting magnitude or direction of discrepancies. Participants (N = 199, M = 51.5 years, SD = 11.7) with FM and insomnia completed 14 days of diaries and actigraphy. Multiple regressions determined whether average opioid dose and its interaction with age predicted magnitude or direction of diary/actigraphy discrepancies in sleep onset latency (SOL), wake after sleep onset (WASO) and sleep efficiency (SE), controlling for sex, use of sleep medication, evening pain and total sleep time. Higher opioid dose predicted greater magnitude of discrepancy in SOL and SE. Opioid dose interacted with age to predict direction but not magnitude of discrepancy in SOL and SE. Specifically, higher opioid use was associated with better subjective (shorter SOL, higher SE) than objective reports of sleep among younger adults, and longer subjective than objectively measured SOL among older adults. Opioid dose did not predict magnitude or direction of WASO discrepancies. In FM, a higher opioid dose increases diary/actigraphy SOL and SE discrepancies, and direction of discrepancies may depend on age. We speculate that increased opioid use combined with age-related factors, such as slow wave sleep disruption, increased awakenings and/or cognitive decline, may impact perceived sleep.
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Actigrafia/métodos , Fibromialgia/complicações , Prontuários Médicos/normas , Transtornos Relacionados ao Uso de Opioides/complicações , Polissonografia/métodos , Distúrbios do Início e da Manutenção do Sono/complicações , Sono/fisiologia , Feminino , Fibromialgia/patologia , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Sleep disturbance and anxiety are highly prevalent in patients with implantable cardiac defibrillators (ICDs). There is limited research, however, on the associations between cognitive performance and sleep parameters, age and anxiety. Forty-one patients with ICDs and self-reported sleep disturbance completed 14 days of actigraphy (Mage = 60.3, SD = 12.3) measuring total sleep time (TST), and a computerized cognitive test battery measuring processing speed and attention (i.e. simple reaction time and symbol digit modality task [SDMT]) and executive function (i.e. flanker task, letter series task and N-back task). Multiple regressions determined whether independent effects of TST, age and anxiety, as well as interactive effects of TST and age, predicted cognitive performance. TST predicted performance on two tasks of executive function (i.e. letter series and N-back task), as well as an attentional vigilance and processing speed task (i.e. SDMT), and this did not depend on patient age. On letter series, N-back and SDMT, longer TST predicted better performance. Increasing age was a predictor of worse performance on SDMT and flanker tasks. No other predictors were associated with task performance. Results show that sleep duration, not anxiety, may be an important predictor of higher-order cognitive functioning and lower-order tasks measuring processing speed and attention in ICD patients, with longer sleep duration showing greater benefit for performance.
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Ansiedade/etiologia , Desfibriladores Implantáveis/efeitos adversos , Testes Neuropsicológicos/normas , Polissonografia/métodos , Sono/fisiologia , Fatores Etários , Desfibriladores Implantáveis/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Individuals with chronic pain are at risk for sleep disruption and heavy alcohol use, yet the daily associations between these behaviours are not well characterized. This study aimed to determine the extent to which alcohol use affects insomnia symptoms and vice versa in adults reporting symptoms of chronic pain. Participants were 73 individuals (93% women) reporting alcohol use in addition to symptoms of insomnia and chronic pain. They completed daily diaries assessing insomnia symptoms and alcohol use for 14 days. Multilevel modelling was used to evaluate the bidirectional associations between alcohol use and insomnia symptoms at the daily level. Consistent with laboratory-based research, alcohol use was associated with decreased sleep-onset latency the same night but increased sleep-onset latency 2 nights later. Specifically, for every alcoholic drink consumed, time to sleep onset decreased by 5.0 min in the same night but increased by 4.3 min 2 nights later. Alcohol use was not significantly associated with subsequent wake after sleep onset or total sleep time, and insomnia symptoms were not significantly associated with subsequent alcohol use. To our knowledge, these data provide the first evidence that alcohol use negatively affects insomnia symptoms up to 2 days post-consumption in patients reporting symptoms of insomnia and chronic pain. Findings suggest that one drink will have minimal impact on sleep, but heavier drinking (e.g. four-five drinks) may have a clinically significant impact (16-25-min increase in sleep-onset latency). Future studies may assess alcohol use as a point of intervention within this population.
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Consumo de Bebidas Alcoólicas/efeitos adversos , Consumo de Bebidas Alcoólicas/fisiopatologia , Dor Crônica/fisiopatologia , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Latência do Sono/fisiologia , Adulto , Consumo de Bebidas Alcoólicas/epidemiologia , Dor Crônica/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Sono/fisiologia , Distúrbios do Início e da Manutenção do Sono/epidemiologiaRESUMO
Fibromyalgia and chronic insomnia are frequently comorbid conditions with heightened sensitivity to painful stimuli, potentially subserved by the hippocampus. Recent evidence suggests moderate alcohol consumption is associated with reduced fibromyalgia symptom severity. We examined the relationship among alcohol use, hippocampal morphology, fibromyalgia, and insomnia symptom severity in 41 fibromyalgia patients (19 with insomnia). A 14-day diary of sleep, pain, and alcohol consumption was followed by structural MRI. Analyses indicated greater bilateral hippocampal volume, lower clinical pain intensity, and better sleep quality in moderate drinkers versus abstainers. Underlying mechanisms may include gamma-amino butyric acid (GABA) receptor agonism, n-methyl d-aspartate (NMDA) receptor antagonism, and psychosocial factors. Further study of the relationship between alcohol use and fibromyalgia and insomnia symptom severity is warranted.
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Consumo de Bebidas Alcoólicas/fisiopatologia , Fibromialgia/complicações , Fibromialgia/fisiopatologia , Hipocampo/patologia , Distúrbios do Início e da Manutenção do Sono/complicações , Distúrbios do Início e da Manutenção do Sono/fisiopatologia , Feminino , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade , Dor/complicações , Dor/fisiopatologia , Receptores de GABA/metabolismo , Receptores de N-Metil-D-Aspartato/antagonistas & inibidores , Receptores de N-Metil-D-Aspartato/metabolismo , Sono/fisiologiaRESUMO
Rates of sleep disorders and associated adjustment were examined in patients with implantable cardioverter defibrillators (ICDs; n = 42; Mage = 61.57, SD = 12.60). One night of ambulatory polysomnography, 14 days of sleep diaries, and questionnaires (mood, sleepiness, fatigue, device acceptance) were administered. Controlling for ischemia, MANCOVA examined adjustment by sleep diagnosis. Apnea was most common (28.6%), followed by Insomnia (16.7%) and Comorbid Insomnia/Apnea (11.9%). Patients with insomnia reported poorer mood, greater sleepiness, and lower device acceptance than good sleepers; they also demonstrated poorer mood and less ICD device acceptance than patients with sleep apnea. Patients with comorbid insomnia/apnea also exhibited poorer mood and less ICD device acceptance than good sleepers; however, comorbid patients did not significantly differ from insomnia or apnea patients on any measure. Those with disordered sleep (regardless of type) reported greater fatigue than good sleepers. Assessment (and treatment) of difficulties with sleep, mood, fatigue, and device acceptance may be important for the comprehensive clinical management of ICD patients. Further research appears warranted.
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Adaptação Psicológica , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/psicologia , Cooperação do Paciente/psicologia , Transtornos do Sono-Vigília/etiologia , Sono/fisiologia , Afeto , Comorbidade , Fadiga/epidemiologia , Fadiga/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polissonografia , Síndromes da Apneia do Sono/epidemiologia , Síndromes da Apneia do Sono/etiologia , Distúrbios do Início e da Manutenção do Sono/epidemiologia , Distúrbios do Início e da Manutenção do Sono/etiologia , Fases do Sono , Transtornos do Sono-Vigília/epidemiologia , Transtornos do Sono-Vigília/psicologia , Inquéritos e QuestionáriosRESUMO
A 78-year-old man with history of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS) syndrome, moderate persistent asthma, pansinusitis, and upper airway cough syndrome presented to the sleep medicine clinic for evaluation of sleep-disordered breathing. Brain MR imaging showed lesions in the pons and midbrain. Diagnostic polysomnography was remarkable for central sleep apnea.
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STUDY OBJECTIVES: To examine whether cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) lead to neural activation changes in response to pain in fibromyalgia. METHODS: Thirty-two patients with fibromyalgia (mean age = 55.9, standard deviation = 12.2) underwent an experimental pain protocol during functional magnetic resonance imaging and completed 14-day diaries assessing total wake time, total sleep time, and pain intensity before and after CBT-I, CBT-P, or waitlist control. Random effects analysis of covariance identified regions with significant group (CBT-I, CBT-P, waitlist control) by time (baseline, post-treatment) interactions in blood oxygen level-dependent response to pain. Linear regressions using residualized change scores examined how changes in total wake time, total sleep time, and pain intensity were related to activation (blood oxygen level-dependent) changes. RESULTS: Twelve regions exhibited small to moderate effects with significant interactions Ps < .00; right hemisphere: inferior frontal, middle occipital, and superior temporal gyri, insula, lentiform nucleus; left hemisphere: angular, superior temporal, midfrontal, inferior occipital, midtemporal, and inferior frontal gyri. Blood oxygen level-dependent response to pain decreased in 8 regions following CBT-I, and in 3 regions following CBT-P (CBT-I effects > CBT-P). Blood oxygen level-dependent response also increased in 3 regions following CBT-P and in 6 regions following waitlist control. Improved total wake time and/or total sleep time, not pain intensity, predicted decreased blood oxygen level-dependence in 7 regions (Ps < .05), accounting for 18%-47% of the variance. CONCLUSIONS: CBT-I prompted greater decreases in neural activation in response to pain across more regions associated with pain and sleep processing than CBT-P. Reported sleep improvements may underlie those decreases. Future research examining the longer-term impact of CBT-I and improved sleep on central pain and sleep mechanisms is warranted. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Sleep and Pain Interventions in Fibromyalgia (SPIN); Identifier: NCT02001077; URL: https://clinicaltrials.gov/ct2/show/NCT02001077. CITATION: McCrae CS, Craggs JG, Curtis AF, et al. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. J Clin Sleep Med. 2022;18(1):203-215.
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Terapia Cognitivo-Comportamental , Fibromialgia , Distúrbios do Início e da Manutenção do Sono , Fibromialgia/complicações , Fibromialgia/terapia , Humanos , Pessoa de Meia-Idade , Dor , Projetos Piloto , Distúrbios do Início e da Manutenção do Sono/complicações , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
The American Academy of Sleep Medicine (AASM) recommends that hypopneas be identified using a definition that is based on a ≥ 30% decrease in airflow associated with a ≥ 3% reduction in the oxygen saturation or an arousal (H3A) for diagnosis of obstructive sleep apnea (OSA) in adults. This conflicts with the Centers for Medicare & Medicaid Services definition, which requires a ≥ 4% decrease in the oxygen saturation to identify a hypopnea (H4) and does not acknowledge arousals. In 2018, the AASM Board of Directors constituted a Hypopnea Scoring Rule Task Force with a mandate to "create a strategy for adoption and implementation of the AASM recommended adult hypopnea scoring criteria among members, payers and device manufacturers." The task force initiated several activities including a survey of AASM-accredited sleep facilities and discussions with polysomnography software vendors. Survey results indicated that most sleep facilities scored polysomnograms using only the Centers for Medicare & Medicaid Services definition. Vendors indicated that they could easily support dual scoring. Informal testing among task force members' sleep facilities confirmed there would be little additional work if dual scoring was performed. The task force convened several meetings of a working group of OSA content experts and interested parties, with the purpose of creating research recommendations to study the impact on relevant clinical outcomes using the different definitions of hypopnea. Several possible prospective and retrospective approaches were discussed with emphasis on the group of patients diagnosed with OSA based on an apnea-hypopnea index using H3A but not H4. Based on the deliberations of the working group, the Hypopnea Scoring Rule Task Force submitted recommendations to the AASM Foundation concerning research project strategies for potential grant funding. Further discussions within the Hypopnea Scoring Rule Task Force focused on developing advocacy initiatives among patient stakeholder groups to change payer policy. CITATION: Berry RB, Abreu AR, Krishnan V, Quan SF, Strollo PJ Jr, Malhotra RK. A transition to the American Academy of Sleep Medicine-recommended hypopnea definition in adults: initiatives of the Hypopnea Scoring Rule Task Force. J Clin Sleep Med. 2022;18(5):1419-1425.
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Síndromes da Apneia do Sono , Apneia Obstrutiva do Sono , Adulto , Idoso , Humanos , Medicare , Estudos Prospectivos , Estudos Retrospectivos , Sono , Síndromes da Apneia do Sono/diagnóstico , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/terapia , Estados UnidosRESUMO
Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.
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Background: The WatchPAT (WP) device was shown to be accurate for the diagnosis of sleep apnea and is widely used worldwide as an ambulatory diagnostic tool. While it records peripheral arterial tone (PAT) and not electrocardiogram (ECG), the ability of it to detect arrhythmias is unknown and was not studied previously. Common arrhythmias such as atrial fibrillation (AF) or premature beats may be uniquely presented while recording PAT/pulse wave. Purpose: To examine the potential detection of common arrhythmias by analyzing the PAT amplitude and pulse rate/volume changes. Patients and Methods: Patients with suspected sleep disordered breathing (SDB) were recruited with preference for patients with previously diagnosed AF or congestive heart failure (CHF). They underwent simultaneous WP and PSG studies in 11 sleep centers. A novel algorithm was developed to detect arrhythmias while measuring PAT and was tested on these patients. Manual scoring of ECG channel (recorded as part of the PSG) was blinded to the automatically analyzed WP data. Results: A total of 84 patients aged 57±16 (54 males) participated in this study. Their BMI was 30±5.7Kg/m2. Of them, 41 had heart failure (49%) and 17 (20%) had AF. The sensitivity and specificity of the WP to detect AF segments (of at least 60 seconds) were 0.77 and 0.99, respectively. The correlation between the WP derived detection of premature beats (events/min) to that of the PSG one was 0.98 (p<0.001). Conclusion: The novel automatic algorithm of the WP can reasonably detect AF and premature beats. We suggest that when the algorithm raises a flag for arrhythmia, the patients should shortly undergo ECG and/or Holter ECG study.
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This document summarizes suggestions of the central sleep apnea (CSA) Technical Expert Panel working group. This paper shares our vision for bringing the right device to the right patient at the right time. For patients with CSA, current coverage criteria do not align with guideline treatment recommendations. For example, CPAP and oxygen therapy are recommended but not covered for CSA. On the other hand, bilevel positive airway pressure (BPAP) without a backup rate may be a covered therapy for OSA, but it may worsen CSA. Narrow coverage criteria that require near elimination of obstructive breathing events on CPAP or BPAP in the spontaneous mode, even if at poorly tolerated pressure levels, may preclude therapy with BPAP with backup rate or adaptive servoventilation, even when those devices provide demonstrably better therapy. CSA is a dynamic disorder that may require different treatments over time, sometimes switching from one device to another; an example is switching from BPAP with backup rate to an adaptive servoventilation with automatic end-expiratory pressure adjustments, which may not be covered. To address these challenges, we suggest several changes to the coverage determinations, including: (1) a single simplified initial and continuing coverage definition of CSA that aligns with OSA; (2) removal of hypoventilation terminology from coverage criteria for CSA; (3) all effective therapies for CSA should be covered, including oxygen and all PAP devices with or without backup rates or servo-mechanisms; and (4) patients shown to have a suboptimal response to one PAP device should be allowed to add oxygen or change to another PAP device with different capabilities if shown to be effective with testing.
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Pressão Positiva Contínua nas Vias Aéreas , Hipóxia , Medicare , Ventilação não Invasiva , Oxigenoterapia , Apneia do Sono Tipo Central , Pressão Positiva Contínua nas Vias Aéreas/instrumentação , Pressão Positiva Contínua nas Vias Aéreas/métodos , Humanos , Hipóxia/diagnóstico , Hipóxia/etiologia , Hipóxia/fisiopatologia , Hipóxia/terapia , Medicare/organização & administração , Medicare/normas , Ventilação não Invasiva/instrumentação , Ventilação não Invasiva/métodos , Oxigenoterapia/instrumentação , Oxigenoterapia/métodos , Seleção de Pacientes , Apneia do Sono Tipo Central/complicações , Apneia do Sono Tipo Central/fisiopatologia , Apneia do Sono Tipo Central/terapia , Tempo para o Tratamento , Estados UnidosRESUMO
Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods:Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical trial registration: NCT04325464 (ClinicalTrials.gov).
Lay abstract Chronic insomnia is linked to a range of health problems, including heart disease, chronic pain, high blood pressure and depression. A behavioral treatment called cognitive behavioral therapy for insomnia (CBT-I) is considered the first choice for helping patients overcome insomnia and reduce their risks of insomnia-related problems. Although the benefits of CBT-I have been established, it can be difficult for patients to access trained CBT-I therapists. One possible solution is to use digital forms of CBT-I, which patients can access on mobile devices. Somryst™ is a prescription digital therapeutic, which means it is authorized by the US FDA and has been proven effective in carefully-controlled clinical trials. Less is known, however, about how well the prescription digital therapeutic works in real-world settings. The Digital Real-world Evidence trial for Adults with insomnia treated via Mobile study (DREAM) will explore this question by evaluating a range of symptoms and outcomes in at least 350 patients with chronic insomnia who will use Somryst and be followed for 1 year.
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Terapia Cognitivo-Comportamental , Distúrbios do Início e da Manutenção do Sono , Adulto , Humanos , Prescrições , Autorrelato , Sono , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Resultado do TratamentoRESUMO
INTRODUCTION: Brief (≤4 sessions) behavioral treatment for insomnia (BBTi) improves insomnia symptoms in older adults. Findings for BBTi-related improvements in objective cognition are mixed, with our recent trial reporting no effects. Metacognition (appraisal of one's own performance) has not been examined. This study examined the effects of BBTi on metacognition in older adults with insomnia. METHODS: Older adults with insomnia [N = 62, Mage = 69.45 (SD = 7.71)] were randomized to 4-weeks of BBTi (n = 32; psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n = 30; social conversations). Throughout the study (2 week baseline, 4 week treatment, 2 week post-treament, 2 week 3-month followup), participants completed daily paper/pencil cognitive tasks (measuring verbal memory, attention, processing speed and reasoning) and provided daily metacognition ratings of their performance in four areas: quality, satisfaction, compared to same age peers, compared to own ability. Two-week averages of metacognitive ratings were calculated for baseline, treatment-first half, treatment-second half, post-treatment, and 3-month follow-up. Multilevel Modeling examined treatment effects (BBTi/SMC) over time on metacognition, controlling for age and sex. RESULTS: A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi. Specifically, baseline ratings [mean (M) = 51.21, standard error (SE) = 3.15] improved at first half of treatment (M = 56.65, SE = 3.15, p < 0.001), maintained improvement at second-half of treatment (p = 0.18), showed additional improvement at post-treatment (M = 60.79, SE = 3.15, p = 0.02), and maintained improvement at follow-up (M = 62.30, SE = 3.15; p = 0.02). SMC prompted inconsistent and smaller improvements between baseline (M = 53.24, SE = 3.29) and first-half of treatment (M = 56.62, SE = 3.28; p = 0.004), with additional improvement at second-half of treatment (M = 59.39, SE = 3.28; p = 0.02) that was maintained at post-treatment (p = 0.73) and returned to levels observed at first-half of treatment (M = 57.78, SE = 3.21; p = 0.55). Significant main effects of time (all ps < 0.001) for other metacognition variables (Quality, Satisfaction, Compared to own ability) indicated general improvements over time for both groups. DISCUSSION: Metacognition generally improved over time regardless of treatment. BBTi selectively improved ratings of performance relative to same age peers. Repeated objective testing alone may improve metacognition in older adults with insomnia. Better understanding of metacognition and how to improve it has important implications for older adults as metacognitive complaints have been associated with mild cognitive impairment.
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Metacognição , Distúrbios do Início e da Manutenção do Sono , Idoso , Terapia Comportamental , Humanos , Pessoa de Meia-Idade , Sono , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do TratamentoRESUMO
NONE: During upward titration of a dose of sodium oxybate therapy for narcolepsy with cataplexy, a 25-year-old woman was observed by her husband to have new onset of knuckle-cracking and moaning behaviors during sleep ≥1 nights each week. The patient did previously occasionally crack her knuckles during the day (but never at night). These behaviors had not been evaluated by polysomnography. After transition of care, polysomnography with video monitoring was ordered and revealed 2 knuckle-cracking episodes that developed out of stage N2 sleep and were likely a non-rapid eye movement sleep parasomnia associated with sodium oxybate treatment.
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Cataplexia , Narcolepsia , Oxibato de Sódio , Adulto , Feminino , Humanos , Polissonografia , Fases do SonoRESUMO
STUDY OBJECTIVES: Decreased early positive airway pressure (PAP) adherence is predictive of poor long-term adherence. We hypothesized that cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact with patients starting treatment would improve early adherence. METHODS: At PAP set-up patients were randomized to: (1) standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC. Primary 3-month endpoints were adherence (all nights, nights used, % of nights ≥ 4 hours use, and % participants with ≥ 4 hours use on ≥ 70% of nights [% ≥ 4 ≥ 70%]) and secondary endpoints were change in Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use. RESULTS: Two hundred fifty participants were randomized (SC 126, SC+CBSC 124). Characteristics SC versus SC+CBSC (mean ± SD) for age (55.2 ± 13.4 versus 54.9 ± 11.5 years), diagnostic apnea-hypopnea index (36.7 ± 21.1 versus 36.6 ± 20.6 events/h), and ESS (10.8 ± 6.1 versus 11.2 ± 6.0) did not differ. At 3 months, the % of days with ≥ 4 hours of PAP use (SC: 48.1 ± 36.8% versus SC+CBSC: 57.9 ± 35.4%, P = 0.032), use all nights (SC:3.7 ± 2.7 hours versus SC + CBSC: 4.4 ± 2.6 hours, P=0.027), and PAPapp use satisfaction were greater with SC+CBSC (intention to treat analysis). The [% ≥ 4 ≥ 70%] did not differ between groups in the intention to treat analysis but was higher in those completing CBSC interventions. The ESS improvement and patient satisfaction did not differ between groups. CONCLUSIONS: The CBSC system improved PAP adherence at 3 months. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: ThErapy Adherence Management in Veterans; Identifier: NCT03243487; URL: https://clinicaltrials.gov/ct2/show/NCT03243487.
Assuntos
Computação em Nuvem , Apneia Obstrutiva do Sono , Adulto , Idoso , Pressão Positiva Contínua nas Vias Aéreas , Humanos , Pessoa de Meia-Idade , Cooperação do Paciente , Sono , Apneia Obstrutiva do Sono/terapia , Resultado do TratamentoRESUMO
BACKGROUND: Studies have established that OSA defined using a hypopnea definition requiring a ≥4% oxygen desaturation (AHI4%) is associated with cardiovascular (CVD) or coronary heart (CHD) disease. This study determined whether OSA defined using a hypopnea definition characterized by a ≥3% oxygen desaturation or an arousal (AHI3%A) is associated with CVD/CHD. METHODS: Data were analyzed from 6307 Sleep Heart Health Study participants who had polysomnography. Self-reported CVD included angina, heart attack, heart failure, stroke, previous coronary bypass surgery or angioplasty. Self-reported CHD included the aforementioned conditions but not stroke or heart failure. The association between OSA and CVD/CHD was examined using logistic regression models with stepwise inclusion of demographic, anthropometric, social/behavioral and co-morbid medical conditions. A parsimonious model in which diabetes and hypertension were excluded because of their potential to be on the causal pathway between OSA and CVD/CHD also was constructed. RESULTS: For CVD, the odds ratios and 95% confidence intervals for AHI3%A ≥30/hour were 1.39 (1.03-1.87) and 1.45 (1.09-1.94) in the fully adjusted and parsimonious models. Results for CHD were 1.29 (0.96-1.74) and 1.36 (0.99-1.85). In participants without OSA according to more stringent AHI4% criteria but with OSA using the AHI3%A definition, similar findings were observed. CONCLUSION: OSA defined using an AHI3%A is associated with both CVD and CHD. Use of a more restrictive AHI4% definition will misidentify a large number of individuals with OSA who have CVD or CHD. These individuals may be denied access to therapy, potentially worsening their underlying CVD or CHD.
RESUMO
STUDY OBJECTIVES: This analysis determined â¼5-year incident hypertension rates using the 2017 American College of Cardiology/American Heart Association blood pressure (BP) guidelines in individuals with obstructive sleep apnea (OSA) with hypopneas defined by a ≥ 3% oxygen desaturation or arousal but not by a hypopnea criterion of ≥ 4% oxygen desaturation (4% only). METHODS: Data were analyzed from participants in the Sleep Heart Health Study exam 2 (n = 1219) who were normotensive (BP ≤ 120/80 mm Hg) at exam 1. The AHI at exam 1 was classified into 4 categories of OSA severity: < 5, 5 ≤ 15, 15 ≤ 30, and ≥ 30 events/h using both the 3% oxygen desaturation or arousal and the 4% only definitions. Three definitions of hypertension-elevated BP (> 120/80 mm Hg), stage 1 (> 130/80 mm Hg), and stage 2 (> 140/90 mm Hg)-were used to determine incidence rates at exam 2. RESULTS: Five-year follow-up was available for 476 participants classified as having OSA by the 3% oxygen desaturation or arousal criterion but not by the 4% only standard at exam 1. Incident hypertension using American College of Cardiology/American Heart Association-defined BP categories in these discordantly classified individuals were 15% (elevated BP), 15% (stage 1), and 6% (stage 2). Hypertensive medications were used in 4% of participants who were normotensive. The overall incidence rate of at least an elevated BP was 40% (191/476) in those with OSA defined using the 3% oxygen desaturation or arousal criterion but not by the 4% only criterion. CONCLUSIONS: Use of the 4% only hypopnea definition resulted in the failure to identify a significant number of individuals with OSA who eventually developed hypertension and could have benefited from earlier diagnosis and treatment.