Clinical trials: Obstructive Sleep Apnea of Adult
Obstructive Sleep Apnea
Evaluation of the Restera™ Serene™ System in Adults With Obstructive Sleep Apnea
The purpose of this multi-center proof-of-concept safety and efficacy study is to collect chronic sleep-related data following percutaneous placement of electrode arrays near the hypoglossal nerve and the ansa cervicalis in…
- Trial name
- REST-HGN+AC (NCT07303452)
- Testing
- Neurostimulation
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Restera, Inc.
Apnea, Sleep Disorders
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive…
- Conditions
- Apnea, Sleep Disorders, Overweight and/or Obesity
- Trial name
- NCT07823608
- Testing
- Berobenatide
- Where
- 6 sites in United States
- Volunteers
- 258 people
- Sponsor
- Pfizer
Obstructive Sleep Apnea, Snoring
LinguaFlex Tongue Retractor (LTR) for the Treatment of OSA and Snoring in Adults
The LinguaFlex™ Tongue Retractor (LTR) is an investigational medical device that is inserted into the tongue to lessen its backward movement during sleep.
- Trial name
- NCT04129229
- Testing
- LinguaFlex Tongue Retractor (LTR)
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Linguaflex, Inc.
Obstructive Sleep Apnea
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
The goal of this clinical trial is to identify which settings of proactive therapy work best in OSA patients who regularly adhere to PAP therapy at home.
- Trial name
- NCT07898254
- Testing
- Dynamic cMAP, Direct cMAP
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- NovaResp Technologies Inc
Sleep Apnea, Sleep Apnea, Obstructive
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06635265
- Testing
- Target Stimulation (HGN, AC, GG, Strap muscles)
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Invicta Medical Inc.
Obstructive Sleep Apnea
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5…
- Trial name
- BETTER SLEEP (NCT03763682)
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 4 sites in Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea, Sleep Apnea Syndromes
Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Trial name
- APNEAL-PMCF (NCT07809633)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Mitral
Obstructive Sleep Apnea
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
- Trial name
- DREAM (NCT03868618)
- Testing
- Genio™ system
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 115 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea of Adult
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe…
- Trial name
- ARCTIC-3 (NCT06008626)
- Testing
- Cryosa Procedure
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cryosa, Inc.
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to [>=] 45 to less than [<] 65…
- Conditions
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
- Trial name
- NCT04647383
- Testing
- Lemborexant 10 mg
- Where
- 11 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea
Effect of Zopiclone on Compliance With Continuous Positive Airway Pressure in Obstructive Sleep Apnea
The clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed OSA who are not currently taking hypnotics for concomitantly diagnosed insomnia.
- Trial name
- NCT01369576
- Testing
- Zopiclone
- Where
- 4 sites in Canada
- Volunteers
- 264 people
- Sponsor
- OSR Medical Inc.
Obstructive Sleep Apnea, Healthy Subjects
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment…
- Trial name
- NCT03471871
- Testing
- Lemborexant 10 mg, Lemborexant 25 mg
- Where
- 11 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
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 of Adult
Baseline Sleep Apnea Study #2
This is a single group, unblinded, prospective clinical study. This study seeks to understand patient diagnostic and treatment journey and positive airway pressure (PAP) therapy compliance for Verily Sleep Apnea (VSA) program/app…
- Trial name
- NCT04599803
- Testing
- Verily Sleep Apnea (VSA) Program/App
- Where
- United States
- Volunteers
- 187 people
- Sponsor
- Verily Life Sciences LLC
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
Obstructive Sleep Apnea of Adult
Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA
ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.
- Trial name
- ARCTIC-1 (NCT04864652)
- Testing
- CHILLS Procedure
- Where
- 2 sites in Panama, Paraguay
- Volunteers
- 84 people
- Sponsor
- Cryosa, Inc.
Obstructive Sleep Apnea of Adult
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep…
- Trial name
- NCT03048604
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 3 sites in Australia, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Nyxoah S.A.
Sleep Apnea, Obstructive
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.
- Trial name
- NCT03796026
- Testing
- Seltorexant 40 mg
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC