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Obstructive Sleep Apnea clinical trials

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NCT ID: NCT04457583 Completed - Clinical trials for Obstructive Sleep Apnea

Inspiratory Muscle Training on Obstructive Sleep Apnea Syndrome

Start date: December 2015
Phase: N/A
Study type: Interventional

Introduction: Studies have shown the influence of exercise on sleep architecture and efficiency, although its protocols, procedures, effects and mechanisms of action have not been clearly explained and documented in the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS), which is thought to be the main sleep disorder due to its high prevalence and clinical, social and cognitive consequences. Objective: To evaluate the effect of inspiratory muscle training (IMT) in OSAHS, by analyzing their influence on the quality of sleep, inspiratory muscle strength and polysomnography parameters. Patients and Methods: Controlled and randomized clinical trial involving 75 patients with OSAHS diagnosed by polysomnography. Measurements of maximal inspiratory pressure (MIP) will be performed. Pittsburgh scale Epworth, Sleepiness Scale, Short Form-36, and Berlin / Stanford questionnaires will be used for assessment of sleep quality, daytime sleepiness, health related quality of life quality of health, and the evaluation of snoring. Patients of the intervention group will undergo IMT with an initial load of 40% of MIP. The intervention will be performed daily for 12 weeks employing the exercise inspiratory device (POWERbreathe, HaB Ltd, UK). The main end point will be the effect of the training program on the index of apnea/hypopnea (IAH) assessed by polysomnography. Secondary end points will include effects of the training program on: the quality of sleep, inspiratory muscle strength, the health related QOL. Expected Results: if the hypothesis is confirmed, there will be improvements on the apnea / hypopnea index, on the quality of sleep and on the health related QOL.

NCT ID: NCT04449133 Completed - Clinical trials for Obstructive Sleep Apnea

Study of AD128 Versus Placebo in Obstructive Sleep Apnea

Start date: July 3, 2020
Phase: Phase 2
Study type: Interventional

Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment. This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.

NCT ID: NCT04445688 Completed - Clinical trials for Obstructive Sleep Apnea

Crossover Trial of AD036 in Obstructive Sleep Apnea

Start date: July 15, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

NCT ID: NCT04427111 Completed - Clinical trials for Obstructive Sleep Apnea

Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

Start date: December 24, 2015
Phase:
Study type: Observational

An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.

NCT ID: NCT04416542 Completed - Clinical trials for Obstructive Sleep Apnea

Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)

HOME
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation

NCT ID: NCT04372329 Completed - Clinical trials for Obstructive Sleep Apnea

Promoting the Use of CPAP Therapy Among OSA Patients

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients. The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.

NCT ID: NCT04299009 Completed - Clinical trials for Obstructive Sleep Apnea

Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Sleep apnea is one of the most common chronic condition among US military Veterans, causing sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life. Persistent daytime symptoms of sleepiness in individuals with Obstructive Sleep Apnea (OSA) who are using Continuous Positive Airway Pressure (CPAP) are associated with adverse long term medical and functional outcomes. Residual daytime sleepiness (RDS) is associated with reduced occupational and family functioning and overall lower quality of life. Napping is a common behavior among individuals with OSA and RDS and has been linked to both benefits to and decline in health and functioning. Longer nap times may maintain, as opposed to decrease, sleepiness by promoting sleep inertia and can contribute to maintaining subclinical circadian alterations that result in higher night-tonight variability in sleep patterns. Preliminary studies in humans and animal models have shown persisting alterations of circadian rhythms in OSA patients, that fail to normalize with CPAP treatment. CPAP treatment, while effective at correcting respiratory events and night time blood oxygen saturation levels, does not necessarily re-align the circadian system. Current treatment options are limited to stimulants and modafinil, whose long-term safety profile, effectiveness and impact on functional recovery is largely unknown. Supplementary exposure to bright light has beneficial effects on sleep quality and daytime vigilance in healthy individuals and it has been increasingly applied in a variety of sleep and neuropsychiatric conditions. However, no study to date has tested the application of BLT to treat daytime symptoms associated with sleep apnea. The investigators' study will be the first to explore the role of Bright Light Therapy (BLT), a well-established non-pharmacological intervention for circadian disturbances, for the treatment of residual daytime symptoms of OSA which do not respond to CPAP.

NCT ID: NCT04251975 Completed - Clinical trials for Obstructive Sleep Apnea

Masked Hypertensive Patients With Obstructive Sleep Apnea

Masked-OSA
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

The general objective is to evaluate the effect of continuous positive airway pressure (CPAP) treatment in patients with masked hypertension. The secondary objectives are: i) To evaluate the prevalence of different circadian patterns of BP in ambulatory blood pressure monitoring (ABPM) (dipper / non-dipper); ii) To assess in these patients the relationship between compliance with CPAP treatment and the response to nocturnal BP; iii) To identify variables of the ABPM, and biomarkers that are related to the unfavourable pattern of nocturnal BP response in these patients treated with CPAP; iv) To evaluate the change in the profile of biomarkers with the treatment. Methodology: Open, parallel, prospective, randomized and controlled study in which an ABPM will be performed in individuals with masked hypertension referred to the sleep unit and diagnosed of OSA (AHI≥ 30) without sleepiness (Epworth≤18). A total of 64 subjects with OSA and masked hypertension will be recruited. It will be collected blood for the determination of biomarkers. Subsequently, they will be randomized to receive treatment with CPAP (32) or conservative treatment (32). After 3 months of initiation, ABPM and biological determinations will be repeated.

NCT ID: NCT04246320 Completed - Clinical trials for Obstructive Sleep Apnea

Taking Brain Monitoring to the Next Level

HDBRAIN
Start date: January 30, 2020
Phase: N/A
Study type: Interventional

This one arm clinical study will assess the impact of a goal directed therapy intervention, aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months after surgery) to determine the relative impact of anesthetic care on the development of postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI) before and after surgical intervention. Patients will also be asked to participate in an optional blood draw which will take place during their brain imaging visit and post operatively (within 2 days after surgery).

NCT ID: NCT04232410 Completed - Clinical trials for Obstructive Sleep Apnea

Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)

Pcrit-DISE
Start date: January 15, 2020
Phase:
Study type: Observational [Patient Registry]

This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.