Clinical trials: Sleep Hypopnea
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
Pediatric Down Syndrome Post-Approval Study
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea.
- Trial name
- NCT06851338
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst.
- Trial name
- NCT01010438
- Where
- 3 sites in Israel
- Volunteers
- 59 people
- Sponsor
- Oridion
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
Central Sleep Apnea
Post Approval Study of the remedē System
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
- Trial name
- NCT03425188
- Where
- 17 sites in United States, Germany
- Volunteers
- 53 people
- Sponsor
- Respicardia, Inc.
Apnea, Sleep
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in…
- Trial name
- NCT02349893
- Testing
- RFA treatment
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Olympus Surgical Technologies Europe
Obstructive Sleep Apnea
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with…
- Trial name
- NCT01211444
- Testing
- HGNS Treatment
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Apnex Medical, Inc.
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.
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 Disordered Breathing, Cheyne Stokes Respiration
Chronic Evaluation of Respicardia Therapy
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA).
- Conditions
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea
- Trial name
- NCT01124370
- Testing
- remedē (TM) system
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Respicardia, Inc.
Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Evaluation of F&P Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P mask in a home environment.
- Trial name
- NCT07847814
- Testing
- F&P Mask
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea…
- Conditions
- Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
- Trial name
- AERO C009E (NCT00849043)
- Where
- 13 sites in United States
- Volunteers
- 65 people
- Sponsor
- Ventus Medical, Inc.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
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.
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
OSA
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data.
- Trial name
- REMAP (NCT05435794)
- Testing
- CPAP, MAD
- Where
- 9 sites in France
- Volunteers
- 400 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
- Trial name
- NCT01186926
- Testing
- HGNS Treatment
- Volunteers
- 40 people
- Sponsor
- Apnex Medical, Inc.
Diastolic Heart Failure
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV device; therapy group).
- Trial name
- ParadiseHF (NCT02254382)
- Testing
- Adaptive servo ventilation (ASV)
- Where
- 2 sites in Germany
- Volunteers
- 2 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Trial name
- NCT02312479
- Testing
- Nyxoah SAT system
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- Nyxoah S.A.