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2.
Trials ; 20(1): 615, 2019 Oct 29.
Artigo em Inglês | MEDLINE | ID: mdl-31665059

RESUMO

BACKGROUND: The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported. METHODS: This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies. DISCUSSION: Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.


Assuntos
Endoscopia/métodos , Avanço Mandibular/métodos , Polissonografia/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Apneia Obstrutiva do Sono/terapia , Pressão Positiva Contínua nas Vias Aéreas , Estudos Cross-Over , Humanos , Mandíbula , Avanço Mandibular/instrumentação , Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa
3.
Sleep Breath ; 19(2): 433-9, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25487311

RESUMO

PURPOSE: Obstructive sleep apnea (OSA) is characterized by repetitive upper airway collapse during sleep, leading to decreased oxygen blood levels and arousal from sleep. The gold standard treatment option for moderate to severe OSA is considered continuous positive airway pressure (CPAP). In case primary treatment with CPAP fails, a reevaluation of disease severity [by means of the apnea/hypopnea-index (AHI)] can be required. A subset of patients that prefer a CPAP alternative is still using CPAP until the reevaluation polysomnography (PSG), and a so-called washout effect is not ruled out. The purpose of this study is to evaluate the evidence on the existence and duration of this washout effect and its clinical relevance for current practice. METHODS: To identify papers for this review, an extensive literature search was run electronically through MEDLINE and EMBASE databases. RESULTS: An overview of currently available literature on this washout effect and the findings of 13 studies on this topic are discussed. CONCLUSION: There is some evidence that CPAP washout exists in patients with a stable BMI throughout the follow-up period. However, the intensity and duration of this effect remains unclear. Within the limitations of the present study, it seems reasonable to maintain a washout period of 1 week, in case alternative treatments options are considered and especially when a baseline PSG (and subsequent repeat PSG after treatment) is needed in case of clinical trials.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas , Procedimentos Cirúrgicos Otorrinolaringológicos , Polissonografia , Apneia Obstrutiva do Sono/terapia , Índice de Massa Corporal , Ensaios Clínicos como Assunto , Terapia Combinada , Comportamento Cooperativo , Humanos , Comunicação Interdisciplinar , Apneia Obstrutiva do Sono/diagnóstico
4.
Chest ; 144(5): 1495-1502, 2013 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-23928873

RESUMO

BACKGROUND: Assessment of the overall therapeutic effectiveness of oral appliance therapy can only be realized through objectively measured compliance. The aims of this study were to assess objectively measured compliance during oral appliance therapy at 1-year follow-up and to compare these data with self-reported use. METHODS: Fifty-one eligible patients were enrolled in this 1-year prospective clinical study (men, 61%; mean age, 49 ± 10 years; apnea-hypopnea index, 18.0 ± 11.9 events/h sleep; BMI, 26.6 ± 4.1 kg/m²). Objective compliance during oral appliance therapy at 1-year follow-up was assessed with a microsensor thermometer. Subjective compliance was assessed by self-report. Patients with a mean objectively measured use of ≥ 4 h/night on 70% of nights monitored were considered regular users. The mean disease alleviation was calculated as a measure of overall therapeutic effectiveness. RESULTS: High agreement between objective and subjective compliance data at 1-year follow-up was reported (intraclass correlation coefficient, 0.8; 95% CI, 0.5-0.9), showing a mean subjective overestimation of 30 min (95% CI, -3.1 to 1.9; P = .02). The discontinuation rate at 1-year follow-up was 9.8%. The objective mean use rate was 6.4 ± 1.7 h/night at 1-year follow-up in continuing users, with a regular use rate of 83%. The mean disease alleviation was 54.9%. CONCLUSIONS: This study is the first to our knowledge to report the 1-year results of objectively measured compliance during oral appliance therapy. In addition, a high agreement between objective and subjective compliance data were reported, with a mean subjective overestimation of 30 min. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01284881; URL: www.clinicaltrials.gov.


Assuntos
Pressão Positiva Contínua nas Vias Aéreas/instrumentação , Cooperação do Paciente , Autorrelato , Síndromes da Apneia do Sono/terapia , Sono , Desenho de Equipamento , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Monitorização Fisiológica , Polissonografia , Estudos Prospectivos , Síndromes da Apneia do Sono/fisiopatologia , Resultado do Tratamento
5.
Sleep ; 36(6): 947-53, 2013 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-23729939

RESUMO

STUDY OBJECTIVE: To determine variations in interobserver and intraobserver agreement of drug-induced sleep endoscopy (DISE) in a cohort of experienced versus nonexperienced ear, nose, and throat (ENT) surgeons. DESIGN: Prospective, blinded agreement study. SETTING: Ninety-seven ENT surgeons (90 nonexperienced with DISE; seven experienced) observed six different DISE videos and were asked to score the upper airway (UA) level (palate, oropharynx, tongue base, hypopharynx, epiglottis), direction (anteroposterior, concentric, lateral), and degree of collapse (none; partial or complete collapse). Findings were collected and analyzed, determining interobserver and intraobserver agreement [overall agreement (OA), specific agreement (SA)] and kappa values per UA level. MEASUREMENT AND RESULTS: In the nonexperienced group, overall interobserver agreement on presence of tongue base collapse (OA = 0.63; kappa = 0.33) was followed by the agreement on epiglottis (OA = 0.57; kappa = 0.23) and oropharynx collapse (OA = 0.45; kappa = 0.09). Low overall interobserver agreement in this group was found for hypopharyngeal collapse (OA = 0.33; kappa = 0.08). A similar ranking was found for degree of collapse. For direction of collapse, high interobserver agreement was found for the palate (OA = 0.57; kappa = 0.16). Among the experienced observers, overall interobserver agreement was highest for presence of tongue base collapse (OA = 0.93; kappa = 0.71), followed by collapse of the palate (OA = 0.80; kappa = 0.51). In this group, lowest agreement was also found for hypopharyngeal collapse (OA = 0.47; kappa = 0.03). Interob-server agreement on direction of collapse was highest for epiglottis collapse (OA = 0.97; kappa = 0.97). Concerning the degree of collapse, highest agreement was found for degree of oropharyngeal collapse (OA = 0.82; kappa = 0.66). Among the experienced observers a statistically significant higher interobserver agreement was obtained for presence, direction, and degree of oropharyngeal collapse, as well as for presence of tongue base collapse and degree of epiglottis collapse. Among the nonexperienced observers, high intraobserver agreement was found in particular for tongue base and epiglottis collapse. Among the experienced observers, high agreement was found for all levels but to a lesser extent for hypopharyngeal collapse. Intraobserver agreement was statistically significantly higher in the experienced group, for all UA levels expect for the hypopharynx. CONCLUSION: This study indicates that both interobserver and intraobserver agreement was higher in experienced versus nonexperienced ENT surgeons. Agreement ranged from poor to excellent in both groups. The current results suggest that experience in performing DISE is necessary to obtain reliable observations.


Assuntos
Competência Clínica/estatística & dados numéricos , Endoscopia/métodos , Otolaringologia/estatística & dados numéricos , Epiglote/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Orofaringe/fisiopatologia , Otolaringologia/métodos , Otolaringologia/normas , Palato/fisiopatologia , Estudos Prospectivos , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/fisiopatologia , Língua/fisiopatologia
6.
J Sleep Res ; 22(3): 348-55, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23205856

RESUMO

The aim of this study was to assess the value of drug-induced sleep endoscopy (DISE) using a custom-made simulation bite in maximal comfortable protrusion (MCP) of the mandible, in the prediction of treatment outcome for obstructive sleep apnea (OSA) with a mandibular advancement device (MAD). Two hundred patients (74% male; age 46 ± 9 years; apnea-hypopnea index [AHI] 19 ± 13 h(-1) sleep; body mass index [BMI] 27 ± 4 kg m(-2) ) with sleep-disordered breathing underwent DISE with a simulation bite in MCP. One hundred and thirty-five patients with an established diagnosis of OSA commenced MAD treatment. The associations between the findings during DISE with simulation bite and treatment outcome were evaluated. Treatment response was defined as a reduction in AHI following MAD treatment of ≥ 50% compared to baseline. Overall MAD treatment response in the studied population was 69%. The results of this study demonstrated a statistically significant association between a positive effect of the simulation bite on the upper airway patency during DISE and treatment response with MAD (P < 0.01). The results of this study suggest that the use of a simulation bite in maximal comfortable protrusion (MCP) of the mandible, as used during DISE in patients with OSA, tends to be effective in predicting treatment response of MAD treatment.


Assuntos
Endoscopia/instrumentação , Avanço Mandibular/instrumentação , Apneia Obstrutiva do Sono/diagnóstico , Adulto , Endoscopia/métodos , Equipamentos e Provisões/normas , Feminino , Humanos , Masculino , Mandíbula/fisiopatologia , Pessoa de Meia-Idade , Polissonografia , Valor Preditivo dos Testes , Sono/fisiologia , Apneia Obstrutiva do Sono/terapia , Resultado do Tratamento
7.
Sleep Med ; 13(3): 314-6, 2012 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22261243

RESUMO

BACKGROUND: It is still subject to controversy if an increased vertical opening (VO) is beneficial in oral appliance therapy for the treatment of obstructive sleep apnoea. Each oral appliance has a given thickness causing VO. Therefore, evaluation of the effects of the amount of VO on pharyngeal dimensions is mandatory. METHODS: The effects of VO on the cross-sectional area of the upper airway at the level of the tongue base during sleep endoscopy were scored and categorised. RESULTS: The figures demonstrate the possible effects of VO on pharyngeal collapse relative to the baseline cross-sectional area and the maximal comfortable protrusion of the mandible. Thirty-two patients (80%) showed an adverse effect of VO (Fig. 1), one patient (2.5%) had a positive effect (Fig. 2), and seven patients (17.5%) demonstrated an indifferent effect (Fig. 3). CONCLUSION: Based on literature, the effect of VO on pharyngeal collapse is unclear and the therapeutic impact of VO is not determined. The results of the present study indicate that the effect of VO on the degree of pharyngeal collapse as assessed during sleep endoscopy tends to be adverse, causing an increase in collapsibility in the majority of patients.


Assuntos
Avanço Mandibular/efeitos adversos , Avanço Mandibular/instrumentação , Faringe/anatomia & histologia , Faringe/fisiopatologia , Apneia Obstrutiva do Sono/fisiopatologia , Apneia Obstrutiva do Sono/terapia , Adulto , Endoscopia , Feminino , Humanos , Masculino , Mandíbula/anatomia & histologia , Mandíbula/fisiologia , Pessoa de Meia-Idade , Sono , Língua/anatomia & histologia
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