Clinical trials: Sleep Hypopnea
Sleep Apnea, Obstructive
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline…
- Trial name
- NCT00467324
- Testing
- Aspire Medical Advance System
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Aspire Medical
Sleep Apnea, Obstructive, Hypopnea Syndrome
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous…
- Conditions
- Sleep Apnea, Obstructive, Hypopnea Syndrome, Excessive Daytime Sleepiness
- Trial name
- NCT00620659
- Testing
- Comparator: MK0249, Comparator: modafinil
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.
- Trial name
- NCT06994650
- Testing
- HRS9531
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
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
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
The goal of this randomised four-period cross-over Phase I study is to assess bioavailability, bioequivalence and tolerability of IHL-42X compared to the reference drugs in healthy volunteers.
- Trial name
- NCT05857384
- Testing
- IHL42X, Acetazolamide 250 MG, Dronabinol 2.5 MG
- Where
- 4 sites in Australia
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Incannex Healthcare Ltd
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
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
Sleep Apnea - Obstructive
A Study of the Sleepnet Elara APAP Device
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
- Trial name
- NCT07559708
- Testing
- Sleepnet Elara Treatment
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Sleepnet Corporation
Obstructive Sleep Apnea
Clinical Evaluation of a Wearable Sleep Diagnosis Technology
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
- Trial name
- NCT03544086
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Acurable Ltd.
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
An Exploratory Investigation of the Use of Drive App to Measure Sleep Parameters in Users of CPAP Therapy
The purpose of this study is to evaluate the usability and suitability of the Drive app (app under test) to measure sleep parameters during CPAP use.
- Trial name
- NCT04500327
- Testing
- Drive app, Non contact motion sensor
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- ResMed
Obstructive Sleep Apnea (OSA)
A Post-marketing Surveillance of the Negative Pressure Sleep Therapy System to Treat Obstructive Sleep Apnea
This is a post-marketing surveillance study to investigate the efficacy and safety of the Negative Pressure Sleep Therapy System for the treatment of obstructive sleep apnea.
- Trial name
- NCT02698059
- Testing
- iNAP® Sleep Therapy System (iNAP)
- Where
- 8 sites in Germany, Taiwan
- Volunteers
- 63 people
- Sponsor
- Somnics, Inc.
Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA)
EURO-STIM Registry
The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits.
- Trial name
- EURO-STIM (NCT06971796)
- Testing
- Inspire UAS System
- Where
- 21 sites in Austria, Belgium and 5 more
- Volunteers
- 1,000 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and…
- Trial name
- NCT07476313
- Testing
- SleepView+
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beacon Biosignals
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation
- Trial name
- ROSTER (NCT07907068)
- Testing
- Phrenic nerve stimulation
- Volunteers
- 300 people
- Sponsor
- Zoll Medical Corporation
Sleep Apnea
Validation of a Contactless Vital Signs Measurement Sensor
The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography.
- Trial name
- NCT04676191
- Testing
- Sleepiz One+, Polysomnography
- Where
- Switzerland
- Volunteers
- 64 people
- Sponsor
- Sleepiz AG
Obstructive Sleep Apnea
CPAP In-home Assessment Australia
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
- Trial name
- NCT02809794
- Testing
- Fisher & Paykel Healthcare CPAP Device
- Where
- 3 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Narcolepsy, Obstructive Sleep Apnea
The Nuvigil and Provigil Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- Trial name
- NCT01792583
- Testing
- Modafinil/armodafinil
- Where
- United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Cephalon, Inc.
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