Clinical trials: Obstructive Sleep Apnea-hypopnea Syndrome
Obstructive Sleep Apnea
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)
The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.
- Trial name
- SEMSAS (NCT04894175)
- Where
- France
- Volunteers
- 302 people
- Sponsor
- Thibaut Gentina
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02730273
- Testing
- Trial Nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
Sleep Apnea, Obstructive
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome.
- Trial name
- HYPNOS (NCT03300037)
- Testing
- Kinesthetic stimulation
- Where
- 5 sites in France
- Volunteers
- 46 people
- Sponsor
- LivaNova
OSAS (Obstructive Sleep Apneas Syndrome)
ISIS 1 Therapeutic Effectiveness
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
- Trial name
- NCT00646477
- Testing
- titration night
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Tyco Healthcare Group
Obstructive Sleep Apnea, Nasal Congestion
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2.
- Conditions
- Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion
- Trial name
- Thermosmart (NCT00665977)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Clayton Sleep Insititute
Obstructive Sleep Apnea
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask.
- Trial name
- NCT02121912
- Testing
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow CPAP mask
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery.
- Trial name
- PREDICTOR (NCT05428839)
- Testing
- Pharyngeal width measurement
- Where
- 10 sites in United States
- Volunteers
- 300 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea, Sleep Apnea
Severe OSA Study (SOS)
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
- Trial name
- NCT05445869
- Testing
- ProSomnus® EVO Sleep and Snore Device
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- ProSomnus Sleep Technologies
Obstructive Sleep Apnea, OSA
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are…
- Conditions
- Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive
- Trial name
- OSPREY (NCT04950894)
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 19 sites in United States
- Volunteers
- 107 people
- Sponsor
- LivaNova
Snoring, Obstructive Sleep Apnea
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or…
- Trial name
- NCT03510403
- Testing
- nastent™
- Where
- 6 sites in France
- Volunteers
- 32 people
- Sponsor
- Seven Dreamers Europe SAS
Obstructive Sleep Apnea
Pediatric Post-Approval Registry
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe…
- Trial name
- NCT04457154
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea (OSA)
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
- Trial name
- AHIBMI PAS (NCT07113288)
- Testing
- Inspire® UAS System
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea, Obstructive, Excessive Daytime Sleepiness
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center…
- Trial name
- NCT06103825
- Testing
- Solriamfetol
- Where
- 26 sites in China
- Volunteers
- 204 people
- Sponsor
- Ignis Therapeutics (Suzhou) Limited
Obstructive Sleep Apnea
PAP-NAP Device Clinical Study
This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment.
- Trial name
- NCT07785310
- Testing
- APL Device
- Volunteers
- 10 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
SLEEP ON Your SIDE (SOS) Study
Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA).
- Trial name
- SOS (NCT04211350)
- Testing
- NightBalance Sleep Position Trainer (SPT), Automatic Positive Airway Pressure (APAP)
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Obstructive Sleep Apnea (OSA) and Obesity
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity not receiving positive airway pressure (PAP)…
- Trial name
- NCT07787260
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea of Adult
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
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…
- Trial name
- NCT03048604
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 3 sites in Australia, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)
The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.
- Trial name
- SEED (NCT05101122)
- Testing
- Dosing 1: Atomoxetine, AD313
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Apnimed