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Sleep Apnea Syndromes clinical trials

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NCT ID: NCT05236075 Completed - Sleep Apnea Clinical Trials

Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar (ET-SAOS-OC)

ET-SAOS-OC
Start date: July 18, 2022
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined. OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents. The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor. Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles. Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down. The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure. The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies. The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.

NCT ID: NCT05235984 Completed - Sleep Apnea Clinical Trials

Technical Feasibility Study on Screening Sleep Related Breathing Disturbances and Sleep Apnoea With Wearable Sensors

Screenbeat
Start date: July 18, 2022
Phase:
Study type: Observational [Patient Registry]

In this study the feasibility of detecting sleep apnoeas with unobtrusive wearable sensors and sounds recorded with a smartphone is studied by making an overnight recording to patients with high probability of sleep apnoeas. The data acquired with the aforementioned devices is: ECG, acceleration, bioimpedance of thorax and processed and raw audio. In data analysis phase it will be studied which combinations of these signals would enable detecting sleep apnoeas with high enough sensitivity and specificity when compared to a night polygraphy reference (Nox T3 device using airflow, breathing movements, audio, position, movement, oxygen saturation, pulse and leg EMG).

NCT ID: NCT05232201 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Vitamin D Levels and Heart Rate Variability on Endothelial Function Via RAAS Augmentation in OSA

RAAS_OSA
Start date: February 2022
Phase:
Study type: Observational

The role of obstructive sleep apnea (OSA) in contributing to hyperaldosteronism, which can lead to increased morbidity and mortality, is less well-established. The vitamin D levels and sympathetic activity of patients with obesity and OSA have not been explored in detail. In this cohort, the role of vitamin D and sympathetic activity, either individually or in combination, on augmenting the renin-angiotensin-aldosterone system (RAAS) causing more endothelial dysfunction remains elusive. We aim to evaluate renin angiotensin aldosterone system in OSA population; elucidate relationship between aldosterone and vitamin D levels in patients with OSA; and to determine association between aldosterone level and vitamin D deficiency with cardio-metabolic derangement in patients with OSA. This is a cross-sectional study involving 150 patients confirmed to have OSA. Participants who fulfil study criteria and consent to study will have blood withdrawn for aldosterone, renin, 25OHD levels with bone profile, and metabolic profile; undergo ultrasound flow mediated dilatation of brachial artery to assess endothelial function; ultrasound of hepatobiliary system to assess fatty liver; 24-hour Holter monitoring to assess sympathetic function; WHOQOLBREF to assess quality of life and Pittsburgh Sleep Quality Index to assess sleep quality.

NCT ID: NCT05230394 Suspended - Sleep Apnea Clinical Trials

Patient Outcomes in Unattended and In- Lab Polysomnography

Start date: August 2023
Phase: N/A
Study type: Interventional

This randomized controlled study will directly evaluate whether unattended polysomnography (level 2 sleep study) in individuals referred for sleep apnea or hypersomnia, including those with comorbidities of insomnia and sleep-related movement disorders, provides similar patient outcomes when compared to level 1 sleep studies.

NCT ID: NCT05224180 Recruiting - Lung Cancer Clinical Trials

OSA in Never Smokers With Lung Cancer

Start date: November 3, 2021
Phase:
Study type: Observational

Previous studies have yielded inconsistent findings regarding the association between obstructive sleep apnea and the prevalence and mortality of lung cancer. Smoking history, a common risk factor for lung cancer, chronic obstructive pulmonary disease, and obstructive sleep apnea, may act as a confounding variable, limiting interpretation of the results. The aim of this study is to evaluate the prevalence of obstructive sleep apnea in never smokers with lung cancer and to determine the effect of obstructive sleep apnea on the prognosis of lung cancer. Enrolled patients will undergo respiratory polygraphy before beginning treatment for lung cancer. This prospective cohort includes both cross sectional and longitudinal analyses.

NCT ID: NCT05219591 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea Treatment With CPAP With and Without the Use of Expiratory Pressure Relief Technology

OSAEPR
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Expiratory pressure relief (EPR) is a technology designed to improve patient comfort during continous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA). The investigators hypothesized that the use of CPAP with EPR is less effective in controlling OSA when compared to CPAP without EPR, applied at the same treatment pressure. The investigators also hypothesized that the CPAP pressure necessary to abolish respiratory events during both manual and automatic CPAP titration with EPR will be greater than the pressure titrated with CPAP without EPR. OSA participants will undergo full polysomnography during CPAP and EPR will be turned on and off in order to test the impact of EPR on airflow and residual AHI.

NCT ID: NCT05210998 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Respiratory Muscle Training Combined With Aerobic Exercise in Obstructive Sleep Apnea Syndrome

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In this study, which was planned to evaluate the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in individuals with OSAS; 40 cases over the age of 40 who were diagnosed with severe (AHI: 30 and over) Obstructive Sleep Apnea Syndrome by polysomnography in the Sleep Laboratory of the Department of Chest Diseases of the Istanbul University Istanbul Medical Faculty Hospital will be included. The cases will be divided into two groups with the randomization system and the education of both groups will continue for a total of 8 weeks. In the literature, it is stated that there is a need for studies on the benefits and results of the use of respiratory muscle training as an adjunct therapy to CPAP or oral devices. No studies were found that evaluated the effects of inspiratory and expiratory respiratory muscle training in addition to aerobic exercise in patients with OSAS. For this reason, OSAS patients using regular CPAP were planned as two groups in the treatment part of this study. Control Group: For gradual aerobic exercise training, bicycle ergometer training in the hospital environment and brisk walking at home once a week (3 days a week, 20-40 minutes a day) will be given under supervision two days a week. Training Group: In addition to the aerobic exercise, the training group will be given respiratory muscle training once a day, 5 days a week, as a home program. Intraoral pressure measurements will be repeated once a week to calculate the new threshold load. Respiratory muscle training: Respiratory muscle training in 50% of MIP and 30% of MEP, as ICE + IME (5 days a week, 15 minutes per day, 15 minutes of IMI). Evaluations will be repeated before and after treatment. The original value of this study is that the effects of Respiratory Muscle Training Combined with Aerobic Exercise in addition to CPAP treatment will be investigated in individuals with OSAS.

NCT ID: NCT05209035 Recruiting - Clinical trials for Obstructive Sleep Apnea

Evaluation of Trazodone in OSA-MCI

Start date: May 10, 2022
Phase: Phase 4
Study type: Interventional

Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD. A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.

NCT ID: NCT05206916 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea Syndrome

New Procedures in Treating Patients With Obstructive Sleep Apnea Syndrome

Start date: May 2022
Phase: N/A
Study type: Interventional

Drug-induced sleep endoscopy (DISE) used as diagnostic tool but not yet as a therapeutic procedures to manage the upper airway of snorers and obstructive sleep apnea patients in conditions that mimic natural sleep, there are many aspects that need to be standardized in order to obtain reliable and reproducible information result in cryotherapy at sites of vibration as origin of snoring and site of collapse.

NCT ID: NCT05204004 Completed - Clinical trials for Obstructive Sleep Apnea

The Sunrise OSA Trial

SOSAT
Start date: August 21, 2021
Phase: N/A
Study type: Interventional

A prospective, randomised, blinded pilot study comparing the Sunrise solution and overnight polygraphy for the diagnosis of OSA in adult patients. Patients under investigation for OSA will use both devices simultaneously for a single overnight sleep study. They will be randomised to receive their treatment decision based on either the Sunrise solution or polygraphy. A retrospective check of their diagnosis will be done.