Digital Therapeutics for Insomnia: Assessing the Effectiveness of a Computerized Home-Based Cognitive Stimulation Program.

BACKGROUND: Sleep disturbances represent a major health burden today, affecting up to one-third of the population worldwide. Computerized cognitive stimulation has been proven as an effective approach in diminishing negative symptomatology and improving the quality of life in a range of medical conditions. Given its nature in enhancing neural networks, such as those involved in stimulus monitoring and inhibitory processes, computerized cognitive stimulation is arising as a potential tool to overcome underlying cognitive deficits found among patients suffering from insomnia. In the current study, we report the results of Phase 1 and Phase 2 clinical trials of a home-based computerized cognitive stimulation program. METHODS: The cognitive stimulation intervention followed a home-based approach with online supervision by a psychologist. The training activities were gamified cognitive tasks that had been designed to improve executive functions, with a focus on inhibition skills. The Insomnia Severity Index and the Pittsburgh Sleep Quality Index scales were used as the main assessment measures. Data from the Behavior Rating Inventory of Executive Function, the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Penn State Worry Questionnaire were also recorded before and after the intervention. During 15 consecutive days, participants performed on alternate days a total of 7 training sessions (each lasting 45 minutes). RESULTS: Twelve patients with clinical insomnia were administered the home-based online cognitive stimulation program. After seven training sessions, mean changes in sleep quality, depressive and anxiety symptoms, worry thoughts, and everyday function were found, with significant improvements in these domains in the full absence of safety issues. CONCLUSIONS: In patients with insomnia, cognitive stimulation demonstrated improvements in sleep quality, mood, and cognitive performance over a 15-day protocol. No relevant side effects were reported. The long-term effectiveness of the intervention is still unknown. CLINICAL TRIAL REGISTRATION: The study protocol has been reviewed and published in ClinicalTrials.gov, assigning it the code NCT05050292 https://clinicaltrials.gov/ct2/show/NCT05050292?term=NCT05050292&draw=2&rank=1.

Study Protocol for a Randomized Controlled Trial Assessing the Effectiveness of Personalized Computerized Cognitive Training for Individuals With Insomnia.

Insomnia is a frequent and heightened pathology in the general population of developed countries, and its condition generally leads to health discomfort and performance drop in daily and work-related tasks. As current pharmacological treatments for insomnia do not always seem sufficient to mitigate impairment, contemporary cognitive approaches might shed light on developing complementary therapies for this population. We propose a cognitive stimulation intervention program based on the importance of cognitive abilities as precipitating and maintenance variables of sleep disturbances. A full phase I-II-III clinical trial is proposed in which the first two studies will serve to assess the safety of the intervention and to identify the maximum tolerated time of the computerized cognitive training (phase I) and the minimum effective number of training sessions (phase II) in the absence of adverse events or side effects. Next, a phase-III double-blind randomized controlled trial design will be set. Sixty individuals with insomnia aged 25 to 55 years will enroll in a home-based personalized computerized cognitive stimulation program for a total time of 8 weeks, training 5 days per week. Sixty insomnia patients matched in a variety of factors will constitute the active control group, where the orthogonal activities will not be cognitively demanding. Sleep, cognitive, emotional, and quality of life variables will be measured before and immediately after training. A linear mixed model and hierarchical regression analysis will be used to investigate intervention effects. The results derived from this study will be precious for future research and treatment in cognitive performance and clinical pathologies. Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT05050292].

Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.

BACKGROUND & OBJECTIVES: Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage. METHODS: We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals. RESULTS: Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis. CONCLUSIONS: Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided.

Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment.

BACKGROUND: In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines. METHODS: We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009. RESULTS: No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03. CONCLUSIONS: Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

Variability in recording and scoring of respiratory events during sleep in Europe: a need for uniform standards.

Uniform standards for the recording and scoring of respiratory events during sleep are lacking in Europe, although many centres follow the published recommendations of the American Academy of Sleep Medicine. The aim of this study was to assess the practice for the diagnosis of sleep-disordered breathing throughout Europe. A specially developed questionnaire was sent to representatives of the 31 national sleep societies in the Assembly of National Sleep Societies of the European Sleep Research Society, and a total of 29 countries completed the questionnaire. Polysomnography was considered the primary diagnostic method for sleep apnea diagnosis in 10 (34.5%), whereas polygraphy was used primarily in six (20.7%) European countries. In the remaining 13 countries (44.8%), no preferred methodology was used. Fifteen countries (51.7%) had developed some type of national uniform standards, but these standards varied significantly in terms of scoring criteria, device specifications and quality assurance procedures between countries. Only five countries (17.2%) had published these standards. Most respondents supported the development of uniform recording and scoring criteria for Europe, which might be based partly on the existing American Academy of Sleep Medicine rules, but also take into account differences in European practice when compared to North America. This survey highlights the current varying approaches to the assessment of patients with sleep-disordered breathing throughout Europe and supports the need for the development of practice parameters in the assessment of such patients that would be suited to European clinical practice.

Factores relacionados con la presencia de disfunción eréctil en pacientes con síndrome de apnea obstructiva del sueño / Factors related with the presence of erectile dysfunction in patients with obstructive sleep apnea

Fundamento y objetivo: El síndrome de apnea obstructiva del sueño (SAOS) puede contribuir al desarrollo de disfunción eréctil (DE) a través de múltiples mecanismos. El objetivo fue identificar los factores que están relacionados con la presencia de DE en estos pacientes. Pacientes y método: Estudio transversal en varones diagnosticados de SAOS. Se recogieron variables demográficas, índice de apneas-hipopneas (IAH), comorbilidad, fármacos, presión arterial, escala Epworth, exploración física, electrocardiograma, índice tobillo-brazo, analítica sanguínea y de orina. La presencia de DE se valoró mediante el cuestionario IIEF-5. Resultados: Se incluyeron 142 pacientes, con una edad media (desviación estándar) de 53 (11) años. La prevalencia de DE fue del 69%. Encontramos diferencias significativas en el IAH entre los pacientes con DE leve y grave (41 [21] frente a 63 [18]; p=0,023). La DE se asoció a la hipertensión arterial [HTA] (odds ratio [OR] 3,56; intervalo de confianza del 95% [IC 95%] 1,64-7,72), hipercolesterolemia (OR 7,19; IC 95% 2,39-21,68), diabetes mellitus tipo 2 (OR 3,07; IC 95% 1,02-9,48) y cardiopatía isquémica (OR 1,51; IC 95% 1,33-1,70), así como al tratamiento con antihipertensivos (OR 4,05; IC 95% 1,76-9,31), hipolipidemiantes (OR 9,71; IC 95% 2,21-22,72), antidiabéticos (OR 3,21; IC 95% 0,69-14,89), antiagregantes y anticoagulantes (OR 6,44; IC 95% 1,45-28,64). Tras el análisis de regresión logística, la DE se asoció con la edad (OR 1,11; IC 95% 1,05-1,16) y la hipercolesterolemia (OR 4,87; IC 95% 1,49-15,96). Conclusiones: Los pacientes con SAOS tienen una alta prevalencia de DE, principalmente en SAOS grave. Los factores que influyen en la presencia de la DE en pacientes con SAOS son fundamentalmente la edad y la hipercolesterolemia. Otros factores que pueden estar relacionados son la HTA, el mal control metabólico, la cardiopatía isquémica y el consumo de antihipertensivos, estatinas y antidiabéticos (AU)

Background and objective: Obstructive sleep apnea (OSA) syndrome can contribute to the development of erectile dysfunction (ED) through multiple mechanisms. The aim was to identify factors influencing the presence of ED in these patients. Patients and methods: Cross sectional study in men diagnosed with OSA by polysomnography. We obtained information about demographic variables, apnea-hypopnea index (AHI), comorbidity, blood pressure, drugs, Epworth Sleepiness Scale, physical examination, electrocardiogram, ankle-brachial index and blood and urine analysis. The presence of ED was assessed by questionnaire IIEF-5. Results: We included 142 patients, mean age was 53 (11) years. The prevalence of ED was 69%. We found significant differences in AHI between patients with mild and severe ED (41 [21] vs 63 [18], P=.023). ED was associated with hypertension (odds ratio [OR]=3.56 [1.64-7.72]), hypercholesterolemia (OR=7.19 [2.39-21.68]), diabetes mellitus type 2 (OR=3.07 [1.02-9.48]) and ischemic heart disease (OR=1.51 [1.33-1.70]); and treatment with antihypertensive (OR=4.05 [1.76-9.31)], lipid-lowering drugs (OR=9.71 [2.2-22.72]), anti-diabetic drugs (OR=3.21 [0.69-14.89]), antiplatelet and anticoagulant agents (OR=6.44 [1.45-28.64]). After logistic regression analysis, only age (OR=1.11 [1.05-1.16]) and hypercholesterolemia (OR=4.87 [1.49-15.96]) were associated with ED. Conclusions: Patients with OSA have a high prevalence of ED, mainly in severe OSA. Factors influencing the presence of ED in patients with OSA are primarily age and hypercholesterolemia. Other factors that may be related include hypertension, poor metabolic control, ischemic heart disease, and treatment with antihypertensive, lipid-lowering and anti-diabetic drugs (AU)

[Factors related with the presence of erectile dysfunction in patients with obstructive sleep apnea]. / Factores relacionados con la presencia de disfunción eréctil en pacientes con síndrome de apnea obstructiva del sueño.

BACKGROUND AND OBJECTIVE: Obstructive sleep apnea (OSA) syndrome can contribute to the development of erectile dysfunction (ED) through multiple mechanisms. The aim was to identify factors influencing the presence of ED in these patients. PATIENTS AND METHODS: Cross sectional study in men diagnosed with OSA by polysomnography. We obtained information about demographic variables, apnea-hypopnea index (AHI), comorbidity, blood pressure, drugs, Epworth Sleepiness Scale, physical examination, electrocardiogram, ankle-brachial index and blood and urine analysis. The presence of ED was assessed by questionnaire IIEF-5. RESULTS: We included 142 patients, mean age was 53 (11) years. The prevalence of ED was 69%. We found significant differences in AHI between patients with mild and severe ED (41 [21] vs 63 [18], P=.023). ED was associated with hypertension (odds ratio [OR]=3.56 [1.64-7.72]), hypercholesterolemia (OR=7.19 [2.39-21.68]), diabetes mellitus type 2 (OR=3.07 [1.02-9.48]) and ischemic heart disease (OR=1.51 [1.33-1.70]); and treatment with antihypertensive (OR=4.05 [1.76-9.31)], lipid-lowering drugs (OR=9.71 [2.2-22.72]), anti-diabetic drugs (OR=3.21 [0.69-14.89]), antiplatelet and anticoagulant agents (OR=6.44 [1.45-28.64]). After logistic regression analysis, only age (OR=1.11 [1.05-1.16]) and hypercholesterolemia (OR=4.87 [1.49-15.96]) were associated with ED. CONCLUSIONS: Patients with OSA have a high prevalence of ED, mainly in severe OSA. Factors influencing the presence of ED in patients with OSA are primarily age and hypercholesterolemia. Other factors that may be related include hypertension, poor metabolic control, ischemic heart disease, and treatment with antihypertensive, lipid-lowering and anti-diabetic drugs.