Active clinical trials for "Sleep Apnea, Obstructive"

This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.

Obstructive sleep apnea is defined as a repetitive collapse of the pharynx during sleep (Malhotra, et al. 2012) which cases intermittent hypoxia. Snoring, witnessed apnea, fatigue and morning headache are symptoms of the disease which has severe health effect (Malhotra. et al. 2012) including increased mortality risk (Ensrud. et al. 2012) and effects on quality of life (Kuhn. et al. 2017). Obesity, male sex and age are all risk factors for obstructive sleep apnea (Schwartz. et al. 2010, Edwards. et al. 2010) . Bariatric surgery is known to be a good treatment to achieve a sustained weight loss but the long term effects of bariatric treatment of obstructive sleep apnea is not well studied. The aim of this study is therefore to study the long effects of bariatric surgery as a treatment for obstructive sleep apnea and to find predictors that can be used to predict the severity of the disease.

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

The purpose of this study is to conduct a pilot randomized, controlled trial to evaluate the feasibility and obtain pilot outcome data for a subsequent definitive trial evaluating the effects of postitive airway pressure (PAP) treatment of obstructive sleep-disordered breathing (OSDB) on blood pressure control and maternal and fetal outcomes in hypertensive disorders of pregnancy. The primary aim of the pilot study is to assess feasibility measured as the rates of subject recruitment, adequate (>4h/night) PAP adherence (primary outcome measure) and protocol completion. Secondary aims will be to obtain preliminary data on the effects of PAP on maternal blood pressure, complications of hypertension, arterial stiffness and vascular biomarkers, course of labor and delivery and fetal outcomes including growth restriction, prematurity, and neonatal distress.

Obstructive sleep apnea (OSA) is the most common type of sleep apnea. The marketplace currently does not have an affordable, easy-to-use, over-the-counter, home-based OSA screening device. An affordable, available, FDA-approved and easy-to-use over-the-counter OSA screening tool would allow greater screening of at-risk individuals, especially in underserved communities with low socioeconomic status, hopefully encouraging a greater proportion of such individuals to seek treatment for their condition. Over the past year, this investigative team has engineered a small screening device (Zerify®) for OSA and obtained preliminary evidence of its efficacy in a clinical population under a NIMHD-sponsored Phase I STTR award. Phase I Specific Aims 1 and 2 focused on developing a small (1.5 x 2.5 x 0.2 inches) semiconductor sensor that could store sound/motion data, transfer these data to a computer, and detect non-clinical simulated apnea events with a specificity and specificity exceeding 90%. Phase I Specific Aim 3 established the preliminary psychometric performance data of the screening device in a clinical sample of 52 patients (13% African American, 6% Asian, 4% Mixed or Other Race) against gold-standard polysomnography. Phase II proposal aims to optimize the engineered hardware and associated OSA algorithms, create a patient companion app and wireless healthcare provider dashboard, and compare the efficacy of this screening device to the most commonly utilized sleep apnea screener, the home sleep apnea test (HSAT).

The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

Study of tongue implant for treatment of obstructive sleep apnea

Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth breathers. Research indicates that nasal breathing not only may improve sleep apnea but it also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing rate, and improves overall lung volumes. Thus, the investigators will test whether a single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth breathers.

Improvement in CPAP adherence can be obtained by usingTelemonitoring. T4P® is a telemonitoring unit added on CPAP device allowing to obtain a daily report of usage duration, mask leaks, pressure and apnea-hypopnea index. The purpose of this study is to assess the impact of telemonitoring on the delay to the first technical intervention after CPAP titration night in CPAP-treated obstructive sleep apnea patients managed in the sleep unit. The shortening of this delay could help to improve adherence during the first weeks of treatment. As a secondary aim, the investigators would like to assess the impact of telemonitoring on mean adherence during the first 3 months of treatment, which is a crucial period.

Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months. Phase 2: To evaluate the CPAP device with communication functionality with data upload.