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Apnea clinical trials

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NCT ID: NCT05180890 Completed - Sleep Apnea Clinical Trials

A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea

Start date: March 10, 2022
Phase: Phase 1
Study type: Interventional

The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously. Before starting treatment with danavorexton, participants will keep a sleep diary and use an under-mattress sensor for at least 7 nights to check regular sleep habits. There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants will receive an intravenous (through the vein) infusion of either danavorexton or a placebo starting in the evening and continuing over a 10-hour period. A placebo looks exactly like danavorexton but does not have any medicine in it. Participants will take part in a follow-up phone appointment about a week after the last Treatment Period.

NCT ID: NCT05175287 Completed - Clinical trials for Sleep Apnea, Obstructive

OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

Our study aims to determine the frequency of individuals at high risk of obstructive sleep apnea, and excessive daytime sleepiness, as well as any potential association between these conditions and traffic accidents among a sample of Ecuadorian bus drivers.

NCT ID: NCT05150470 Completed - Clinical trials for Sleep Apnea Syndromes

Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome

DPOAM
Start date: November 25, 2021
Phase: N/A
Study type: Interventional

The DO OAM study is a mono-center, interventional, prospective study carried out in CH VALENCE. It will estimate the prevalence of dental movements in patients treated by oral Appliance for Sleep Apnea syndrome. The investigators will used fingerprinting technique by taking multiple photographs of the teeth that allow for the three-dimensional reconstruction of the teeth this study will provide a better understanding of dental movement caused by oral appliance

NCT ID: NCT05139303 Completed - Clinical trials for Obstructive Sleep Apnea

Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

Start date: November 15, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular advancement device and describe the percentage of advancement (%) needed to reach efficacy, and to retrospectively compare with other MAD designs in the management of obstructive sleep apnea. Additionally, to describe patient compliance and adherence to the therapy with the Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA® mandibular advancement device.

NCT ID: NCT05135494 Completed - Stroke Clinical Trials

Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke

Start date: November 30, 2021
Phase: N/A
Study type: Interventional

The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial. This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program. Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness

NCT ID: NCT05134402 Completed - Clinical trials for Obstructive Sleep Apnea

Recording of Multiple Nights Using a New Contactless Device (Sleepiz One Connect) in Obstructive Sleep Apnea

Start date: December 1, 2021
Phase:
Study type: Observational

The need for multiple night testing is well recognized in sleep medicine because of a considerable and relevant night-to-night variability. In a study with multiple recordings using WatchPAT®, the OSA severity of 24% of patients was misclassified when using one night compared to the average of three nights. On average, pAHI varied by 57% from night-to-night. The variability of pAHI could partially be explained by the variability of time spent in the supine position with more time supine leading to a higher pAHI (Tschopp et al 2021). Smith (2007) suggested that the AHI should be indicated with a confidence interval to indicate the uncertainty regarding its true value. The Minimal Detectable Difference (MDD) is of special interest in sleep medicine, especially when assessing treatment effects. MDD was found to be 12.8/h and the standard error of measurement was 4.6/h for 4 nights of polysomnography (Aarab et al. 2008). For WatchPAT®, measuring two and three nights showed a small reduction in MDD from 19.1/h to 18.0/h (Tschopp et al. 2021, in press). Only one study using pulse oximetry assessed the night-to-night variability over 14 days (Stöberl A. et al 2017). The study confirmed the enormous variability and focused mainly on its impact on OSA severity. While the night-to-night variability has been extensively studied for polysomnography, respiratory polygraphy, and WatchPAT®, little is known about the optimal number of nights to be recorded. There is convincing evidence from the literature, that the recording of multiple nights is the only way to assess the severity of the patient's disease with clinically reasonable accuracy. Moreover, the MDD with only one night's recording is astonishingly high. The question is how many nights should be recorded to achieve acceptable diagnostic accuracy. The precision of the OSA measurement depends on the clinical situation. For example, to diagnose severe OSA, a higher variability might be acceptable without influencing the treatment decision. However, when comparing treatment effects, the MDD should be as small as possible. The recording of multiple nights might be cumbersome for patients (e.g. with polysomnography or respiratory polygraphy) as well as costly. These factors have to be taken into consideration for the clinically feasible number of recordings. Sleepiz One Connect offers the unique opportunity for a contactless recording of breathing combined with conventional pulse oximetry and is a minimally invasive diagnostic tool that allows measurements over several nights. Studies with multiple night recordings will offer a basis for diagnostic recommendations in future guidelines. The study aims to investigate the variability of obstructive sleep apnea at-home sleep apnea testing. By investigating the variability, we want to quantify the improvement in diagnostic accuracy by additional measurements. The hypothesis is that additional recordings offer a significant improvement in diagnostic accuracy by reducing the variability. The reduction in variability will diminish with each additional recording.

NCT ID: NCT05133011 Completed - Clinical trials for Sleep Apnea, Obstructive

Force Sensing Resistor for Obstructive Sleep Apnea Patients After Tongue Base Reduction Surgery

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

Obstructive sleep apnea syndrome (OSA) is a sleep-related breathing disorder defined by repetitive episodes of apnea and hypopnea. These traits include anatomical (narrow/crowded/collapsible upper airway) and nonanatomical (waking up too easily during airway narrowing [a low respiratory arousal threshold], ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control [high loop gain]) components. Oropharyngeal training reduces the snoring times, Apnea-hypopnea Index (AHI) and daytime sleepiness. There is lack of good evaluating tools to distinguish different phenotypes of OSA and the efficacy of combined therapy. The purposes of our study are (1) to evaluate OSA patient by using Polysomonogrphy (PSG), force sensing resistor (FRS), Drug induce sleep endoscopy (DISE) and CT and muscle strength testing, (2) to know the exercise times by using FSR and (3) the efficacy of exercise in different groups.

NCT ID: NCT05127239 Completed - Clinical trials for Obstructive Sleep Apnea

The Effectiveness of Smartphone Application on the Serevity of Obstructive Sleep Apnea

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

A two-year study design is formulated. The overall aim of this study is to examine the effectiveness of the care model combing smartphone application on improve obstructive apnea in obesity adults.

NCT ID: NCT05124093 Completed - Anesthesia Clinical Trials

The Effect of High-flow Nasal Oxygen Flow Rate on Gas Exchange During Apnoea

Apox-HFNO
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

Apnoeic oxygenation refers to oxygenation that occurs through the insufflation of oxygen into the lungs in the absence spontaneous respiration or positive pressure ventilation. It is used to extend the time to desaturation at induction of anaesthesia and as a primary oxygenation technique during airway surgery. The impact of high-flow nasal oxygen flow rate selection on gas exchange is poorly understood. Participants in this study will be randomised to receive a certain nasal oxygen flow rate during apnoea and its effect on gas exchange will be measured by blood gas analysis.

NCT ID: NCT05110352 Completed - Clinical trials for Obstructive Sleep Apnea

Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

RESTECH
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome. It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.