Clinical trials: Obstructive Sleep Apnea
Sleep Apnea, Sleep Apnea, Obstructive
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06635265
- Testing
- Target Stimulation (HGN, AC, GG, Strap muscles)
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Invicta Medical Inc.
Obstructive Sleep Apnea
KPAP Adherence Crossover Study
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive…
- Trial name
- NCT06413134
- Testing
- KPAP, APAP
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with…
- Trial name
- NCT01211444
- Testing
- HGNS Treatment
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Apnex Medical, Inc.
Obstructive Sleep Apnea
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and…
- Trial name
- NCT02297789
- Testing
- Investigative Full Face Mask with Headgear
- Where
- New Zealand
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
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
Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm
This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep…
- Trial name
- NCT03070756
- Testing
- Minimal-Intervention - Specification of device settings
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Heinen und Löwenstein GmbH & Co. KG
Obstructive Sleep Apnea
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM
- Trial name
- PoP IN VAuto (NCT02930460)
- Where
- 8 sites in France
- Volunteers
- 30 people
- Sponsor
- ResMed
Sleep Apnea, Obstructive
Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea
A multicentre, randomized controlled trial (RCT) design.The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on…
- Trial name
- PIMA1-JO-PR (NCT04691479)
- Testing
- Motivational Interview (MI) & Adherence Follow-Up, Adherence Follow-Up
- Where
- Spain
- Volunteers
- 129 people
- Sponsor
- Air Liquide Healthcare Spain
Obstructive Sleep Apnea (OSA)
Study of Min-Max APAP Recommender Tool
Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients.
- Trial name
- SMART (NCT07400861)
- Testing
- CPAP with min-max recommender tool, CPAP with default settings
- Where
- Australia
- Volunteers
- 90 people
- Sponsor
- ResMed
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
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
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Obstructive Sleep Apnea
Pivotal Study of the iNAP® in Adults With OSA
A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)
- Trial name
- NCT03544463
- Testing
- iNAP® Sleep Therapy System
- Where
- Taiwan
- Volunteers
- 32 people
- Sponsor
- Somnics, 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.
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
Sleep Apnea
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
- Trial name
- NCT00906958
- Testing
- Nexus Flow Generator, VPAP Flow Generator 25
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA).
- Trial name
- NCT06008678
- Testing
- RXiBreeze PAP System, Model RXiBreeze 20A
- Where
- 9 sites in United States
- Volunteers
- 146 people
- Sponsor
- Resvent Holding USA LTD