Clinical trials: Obstructive Sleep Apnea-Hypopnea Syndrome
Sleep Disordered Breathing, Obstructive Sleep Apnea
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00922168
- Where
- 2 sites in United States
- Volunteers
- 146 people
- Sponsor
- Cleveland Medical Devices Inc
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
PAP Systems Internal Clinical Studies (ICS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.
- Trial name
- NCT06173050
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Obstructive Sleep Apnea
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5…
- Trial name
- BETTER SLEEP (NCT03763682)
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 4 sites in Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea, Sleep Apnea Syndromes
Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Trial name
- APNEAL-PMCF (NCT07809633)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Mitral
Obstructive Sleep Apnea
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.
- Trial name
- NCT01369576
- Testing
- Zopiclone
- Where
- 4 sites in Canada
- Volunteers
- 264 people
- Sponsor
- OSR Medical Inc.
Apnea (Central and Obstructive)
MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)
A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence.
- Trial name
- MEntA Program (NCT07258264)
- Testing
- Motivational Interviewing (MI), Competency-based learning
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Air Liquide Healthcare Spain
Obstructive Sleep Apnea
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the…
- Trial name
- NCT01797705
- Testing
- DeVilbiss AutoAdjust CPAP with revised algorithm
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DeVilbiss Healthcare LLC
Obstructive Sleep Apnea, Sleep Apnea
The Comfort of Proactive Sleep Apnea Therapy
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question[s] it aims to answer are: To assess if proactive therapy can effectively treat OSA with lower mean therapy…
- Trial name
- NCT06144892
- Testing
- Proactive Therapy
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- NovaResp Technologies Inc
Obstructive Sleep Apnea
Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea
A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device. The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory…
- Trial name
- keePaOSA (NCT04875897)
- Testing
- keepMED PAP device
- Volunteers
- 65 people
- Sponsor
- keepMED Ltd.
Mild-Moderate Obstructive Sleep Disordered Breathing
Non-Inferiority Trial of Acute HFT Versus nCPAP
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
- Trial name
- NCT01860560
- Testing
- High-Flow Therapy, Continuous Positive Airway Pressure
- Where
- United States
- Sponsor
- Vapotherm, Inc.
Obstructive Sleep Apnea
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep…
- Trial name
- NCT03230877
- Testing
- Toffee full face mask with 'Improved Seal', Toffee full face mask with 'Normal Seal'
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a…
- Trial name
- NCT02851628
- Testing
- Alternative sizing model based trial mask, Prototype Full Face Mask
- Where
- 4 sites in New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Oran Park Mask External Clinical Study (3) Marketing Claims Study
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home…
- Trial name
- NCT06079866
- Testing
- Mask A (Oran Park Mask) then Mask B (Evora Mask), Mask B (Evora Mask) then Mask A (Oran Park Mask)
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Patient Perception Questionnaire Validation
Validation of the patient perception questionnaire relating to CPAP use
- Trial name
- NCT02067000
- Testing
- Obstructive Sleep Apnea
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
The purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.
- Trial name
- NCT00672061
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Takeda
Obstructive Sleep Apnea
StimAire Sleep Study
The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor.
- Trial name
- NCT05374941
- Testing
- Injectable and wearable neurostimulator for the hypoglossal nerve
- Where
- Australia
- Volunteers
- 7 people
- Sponsor
- StimAire Australia Pty Ltd
Obstructive Sleep Apnea, Healthy Subjects
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment…
- Trial name
- NCT03471871
- Testing
- Lemborexant 10 mg, Lemborexant 25 mg
- Where
- 11 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea
AD109 Dose Finding in Mild to Moderate OSA
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
- Trial name
- NCT04631107
- Testing
- AD109 dose1- A, AD109 dose2- B
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy.
- Trial name
- NCT01831258
- Testing
- SensAwake On, SensAwake Off
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Fisher and Paykel Healthcare