Clinical trials: Sleep Apnea Syndromes, Obstructive
Obstructive Sleep Apnea
AutoSet for Her Clinical Trial Protocol
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.
- Trial name
- NCT01826513
- Testing
- Standard AutoSet algorithm, Modified AutoSet algorithm
- Where
- Australia
- Volunteers
- 25 people
- Sponsor
- ResMed
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.
Sleep Apnea, Obstructive
PIMA - Individualized Adherence Improvement Plan
Continuous positive airway pressure (CPAP) is the first-line treatment for sleep apnoea/hypopnoea syndrome (OSA). The aim of this study is to know the results in adherence to CPAP and health related outcomes in patients with OSA…
- Trial name
- PIMAGASOXMED (NCT04650061)
- Testing
- Motivational Interview (MI) & Adherence Follow-Up, Adherence Follow-Up
- Where
- Portugal
- Volunteers
- 200 people
- Sponsor
- Air Liquide Healthcare Spain
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT02894242
- Testing
- F&P Deimos Nasal Pillows Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 22 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive, Sleep Apnea, Central
Application of Forced Breath Technique While CPAP Therapy for Apnea Classification
This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas during CPAP therapy with a prismaLAB (device name) therapy device.
- Trial name
- FBT-CPAP (NCT03432910)
- Testing
- CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Heinen und Löwenstein GmbH & Co. KG
Obesity Hypoventilation Syndrome
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.
- Trial name
- NCT02486380
- Testing
- Toffee full face mask/toffee nasal mask
- Where
- New Zealand
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
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
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus…
- Trial name
- OREM (NCT05183009)
- Testing
- eXciteOSA
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Signifier Medical Technologies
Snoring, OSA - Obstructive Sleep Apnea
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites.
- Trial name
- NCT07613281
- Testing
- Palatal Implant System
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Serene Sleep, Inc.
Obstructive Sleep Apnea
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or…
- Trial name
- BREATHE (NCT07331285)
- Testing
- This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
- Where
- 2 sites in United States
- Volunteers
- 229 people
- Sponsor
- Nyxoah Inc.
Sleep Apnea, Obstructive
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.
- Trial name
- NCT01943708
- Testing
- SPAP, CPAP
- Where
- New Zealand
- Volunteers
- 74 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05570747
- Testing
- Usability
- Where
- 3 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
SleepFlexTM Treatment of Obstructive Sleep Apnea
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
- Trial name
- NCT04726514
- Testing
- SleepFlex
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Berendo Scientific, LLC
Obstructive Sleep Apnea (OSA)
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA.
- Trial name
- NCT02639884
- Testing
- SedLine EEG, RRa monitoring
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Masimo Corporation
Obstructive Sleep Apnea
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
Minimally invasive electrical stimulation of the nerve hypoglossal for the treatment of obstructive sleep apnea. To demonstrate the correct stimulation of the medial branches of the hypoglossal nerve and tongue protrusion using a…
- Trial name
- NCT05914948
- Testing
- Medtronic 8-contact Vectris subcompact or compact electrode.
- Where
- Colombia
- Volunteers
- 20 people
- Sponsor
- Capri Medical Limited
Obstructive Sleep Apnea
Post Market Clinical Follow up of ResMed Mask Systems
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
- Trial name
- NCT05262439
- Testing
- New generation CPAP mask
- Where
- Australia
- Volunteers
- 500 people
- Sponsor
- ResMed
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 (OSA)
DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.
The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.
- Trial name
- DReAMzz (NCT07635563)
- Testing
- IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
- Where
- 13 sites in United States
- Volunteers
- 120 people
- Sponsor
- Incannex Healthcare Ltd
Obstructive Sleep Apnea
A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose
BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.
- Trial name
- NCT04872387
- Testing
- BAY2586116
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Obesity-Hypoventilation Syndrome (OHS)
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings.
- Trial name
- NIV-OHS (NCT00603096)
- Testing
- GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Tyco Healthcare Group