Clinical trials: Obstructive Apnea
Obstructive Sleep Apnea (OSA)
Vent Flow Study of Prototype Nasal CPAP Mask
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology.
- Trial name
- GVFECT (NCT02805777)
- Testing
- CPAP mask
- Sponsor
- ResMed
Sleep Apnea, Obstructive
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
- Trial name
- NCT00751335
- Testing
- CPAP with ThermoSmart, then CPAP without ThermoSmart, CPAP without ThermoSmart, then CPAP with ThermoSmart
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Study, SHH
The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for sleep apnea screening.
- Trial name
- NCT06633887
- Where
- Taiwan
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
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
Obstructive Sleep Apnea
Targeted Hypoglossal Neurostimulation Study #3
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have…
- Trial name
- THN3 (NCT02263859)
- Testing
- aura6000 System
- Where
- 20 sites in United States, Belgium and 4 more
- Volunteers
- 138 people
- Sponsor
- ImThera Medical, Inc.
Sleep Apnea, Snoring
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study. The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by…
- Trial name
- NCT04250584
- Testing
- iSlpr™, SomnoDent® Classic
- Volunteers
- 66 people
- Sponsor
- BioAnalytics Holdings Pty Ltd
Respiratory Failure, Neuromuscular Disease
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Acute Exacerbation of Respiratory Failure
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients admitted to hospital with acute exacerbation of chronic respiratory failure.
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease
- Trial name
- NCT01174316
- Testing
- AutoVPAP™, VPAPIIIST-A™
- Where
- United Kingdom
- Sponsor
- ResMed
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- NCT01532180
- Testing
- aura6000 System
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- ImThera Medical, Inc.
Sleep Apnea, Obstructive
SensAwake™ Sleep Quality Trial
The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake.
- Trial name
- SASQT (NCT00811213)
- Testing
- SleepStyle 200 Auto Series with SensAwake, SleepStyle 200 Auto Series with out SensAwake
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)
Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data
- Trial name
- NCT02590159
- Testing
- BONGO NASAL EPAP
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InnoMed Healthscience Inc.
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
KPAP vs EPR for Comfort
The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR.
- Trial name
- NCT07530510
- Testing
- APAP + KPAP, APAP + EPR
- Volunteers
- 24 people
- Sponsor
- SleepRes Inc.
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
Obesity, Obstructive Sleep Apnea
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway…
- Trial name
- MARITIME-OSA-1 (NCT07225686)
- Testing
- Maridebart cafraglutide
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 250 people
- Sponsor
- Amgen
Obstructive Sleep Apnea
PAP Systems External Clinical Studies (ECS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
- Trial name
- NCT06562205
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Obstructive Sleep Apnea
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway…
- Trial name
- REPOSA (NCT06146101)
- Testing
- IHL-42X Low Dose, IHL-42X High Dose, IHL-42X (Optimal Dose)
- Where
- 20 sites in United States
- Volunteers
- 121 people
- Sponsor
- Incannex Healthcare Ltd
Obstructive Sleep Apnea (OSA)
Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Not Treated With Positive Airway Pressure (PAP) Therapy
This study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of GZR18 injection in obese subjects with moderate to severe obstructive sleep apnea…
- Trial name
- NCT07493057
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Obstructive Sleep Apnea
Severe Label Expansion for EVO Products Trial
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus…
- Trial name
- SLEEP (NCT07090395)
- Testing
- EVO Sleep and Snore Device
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- ProSomnus Sleep Technologies
Obstructive Sleep Apnea
Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the continuous positive airway pressure (CPAP) group after 90…
- Trial name
- BiPAPRescue (NCT02522442)
- Testing
- CPAP, Auto BiLevel
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Philips Respironics