Clinical trials: Obstructive Sleep Apnea-hypopnea Syndrome
Mild Obstructive Sleep Apnea
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
- Trial name
- NCT07492420
- Testing
- MedCline Sleep System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Amenity Health, Inc.
Obstructive Sleep Apnea
Crossover Trial of AD109 in Obstructive Sleep Apnea
This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.
- Trial name
- NCT04580394
- Testing
- AD109, Atomoxetine, R-oxybutynin
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea
Safety and Effectiveness of Slow Wave Device for the Treatment of Obstructive Sleep Apnea
This is a safety and efficacy trial for a Slow Wave, Inc. UASD oral appliance for the treatment of Obstructive Sleep Apnea. This trial will recruit 60-80 participants through our IRB partner.
- Trial name
- NCT06519149
- Testing
- Slow Wave UASD
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Slow Wave, 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
Obesity, Overweight
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA)…
- Conditions
- Obesity, Overweight, Osteoarthritis, Knee, Obstructive Sleep Apnea
- Trial name
- TRIUMPH-1 (NCT05929066)
- Testing
- Retatrutide
- Where
- 134 sites in United States, Australia and 10 more
- Volunteers
- 2,335 people
- Sponsor
- Eli Lilly and Company
Sleep Apnea, Obstructive
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard…
- Trial name
- NCT01517763
- Testing
- Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Workflow Validation of an In-home Auto-titrating Mandibular Positioner
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance…
- Trial name
- NCT02933112
- Testing
- Auto-titrating mandibular positioner test
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Zephyr Sleep Technologies
Sleep Apnea, Obstructive
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification.
- Trial name
- NCT00681083
- Testing
- Heated breathing tube (CPAP with ThermoSmart), Non heated breathing tube (CPAP with conventional humidification)
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)
Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation
- Trial name
- HOME (NCT04416542)
- Testing
- Home Sleep Testing
- Where
- 5 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- 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.
Obstructive Sleep Apnea
PAP Systems Internal Clinical Studies (ICS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.
- Trial name
- NCT06173050
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Positive Airway Pressure Therapy, Obstructive Sleep Apnea
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy…
- Trial name
- NCT04615832
- Testing
- Toffee Full Face Mask
- Where
- 3 sites in New Zealand
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Obstructive Sleep Apnea
Crossover Trial of AD036 in Obstructive Sleep Apnea
This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.
- Trial name
- NCT04445688
- Testing
- AD036, Atomoxetine
- Where
- 5 sites in United States
- Volunteers
- 62 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea, Preoperative Evaluation
Systematic Screening for Obstructive Sleep Apnea During Preoperative Consultation Using AI-preoperative Agents
The goal of this observational study is to evaluate the feasibility of a systematic screening protocol for Obstructive Sleep Apnea (OSA) during preoperative anesthesia consultations in adults aged 50 and older undergoing elective…
- Trial name
- DASCA (NCT06779682)
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Intelligence Anesthesia
Obstructive Sleep Apnea
Evaluation of an Incentive-based Intervention to Improve 90-day Adherence in PAP-Naive Patients
This is a prospective, randomized, open-label study to evaluate effectiveness of applying financial and social incentives via a smartphone-based app in helping participants achieve adherence to PAP therapy.
- Trial name
- Project Dahlia (NCT03851094)
- Testing
- Wellth app
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Whitsundays (Nasal) Mask Take Home Study (90 Days)
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea.
- Trial name
- NCT06036329
- Testing
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- ResMed
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
Sleep, Obstructive Sleep Apnea
Study Watch Sleep Metric Performance Characterization Study
This is a multi-center, single-arm, prospective performance evaluation study designed to assess performance of sleep metrics calculated from sensor data that is collected from two versions of the Verily Study Watch as compared to…
- Conditions
- Sleep, Obstructive Sleep Apnea, Insomnia
- Trial name
- NCT05276362
- Testing
- Study Watch, Actiwatch
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Verily Life Sciences LLC