Clinical trials: Sleep Hypopnea
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
Sleep Apnea
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea.
- Trial name
- NCT03775291
- Testing
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Where
- 6 sites in United States, Ireland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Heart Failure, Congestive, Sleep Apnea Syndromes
Investigation of Heart Failure Status Over Time Using Respiratory Parameters
The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.
- Trial name
- NCT00494117
- Testing
- ApneaLink
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- ResMed
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
Narcolepsy, Obstructive Sleep Apnea
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
The purpose of study JZP110-401 is to evaluate solriamfetol pharmacokinetics (PK) in the breast milk and plasma of healthy postpartum women following the administration of the drug.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence, Excessive Sleepiness
- Trial name
- NCT05008341
- Testing
- Solriamfetol 150 mg Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Axsome Therapeutics, Inc.
Obstructive Sleep Apnea
AutoSet for Her Quality of Life Clinical Trial
Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female…
- Trial name
- FEM-PAP (NCT02400073)
- Testing
- AutoSet for Her
- Where
- 3 sites in Germany, Spain
- Volunteers
- 122 people
- Sponsor
- ResMed
Obstructive Sleep Apnea Syndrome
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
- Trial name
- NCT00685269
- Testing
- Eszopiclone
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Obstructive Sleep Apnea
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (STM) compared to placebo on sleep apnea activity in adult…
- Trial name
- NCT05236842
- Testing
- Sulthiame
- Where
- Belgium
- Volunteers
- 298 people
- Sponsor
- Desitin Arzneimittel GmbH
Obstructive Sleep Apnea, Sleep Apnea
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
- Trial name
- CO-STAR (NCT05608486)
- Testing
- aerSleep II
- Sponsor
- Sommetrics, Inc.
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.