Clinical trials: Obstructive Apnea
Obstructive Sleep Apnea
Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation
The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or…
- Trial name
- BREATHE (NCT07331285)
- Testing
- This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
- Where
- 2 sites in United States
- Volunteers
- 229 people
- Sponsor
- Nyxoah Inc.
Obstructive Sleep Apnea, OSA
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are…
- Conditions
- Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive
- Trial name
- OSPREY (NCT04950894)
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 19 sites in United States
- Volunteers
- 107 people
- Sponsor
- LivaNova
Obstructive Sleep Apnea
Oran Park Mask External Clinical Study (3) Marketing Claims Study
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home…
- Trial name
- NCT06079866
- Testing
- Mask A (Oran Park Mask) then Mask B (Evora Mask), Mask B (Evora Mask) then Mask A (Oran Park Mask)
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Obesity
UBT251 Injection Phase Ⅲ Study (OSA-PAP)
UBT251 will be compared with placebo (an inactive substance identical in appearance) to evaluate its therapeutic effect in participants with moderate-to-severe obstructive sleep apnea maintained on positive airway pressure…
- Trial name
- UNISHAPE-OSA-2 (NCT07806851)
- Testing
- UBT251
- Volunteers
- 150 people
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
Sleep Apnea Central, Cheyne-Stokes Respiration
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying…
- Conditions
- Sleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
- Trial name
- NCT01175031
- Testing
- Manipulation of Positive Airway Pressure (PAP)
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Philips Respironics
Weight Management
A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea
- Trial name
- NCT06565871
- Testing
- HRS9531 Injection
- Volunteers
- 108 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea Syndrome
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in…
- Trial name
- NCT00086281
- Testing
- Xyrem (X), Zolpidem (Z), Modafinil (M)
- Where
- 2 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea
Humidification Needs
A study undertaken to investigate mouth leak for airway discomfort/dryness while using CPAP. This study will also measure how much humidification is required to treat subsequent upper airway discomfort/dryness from mouth leak by…
- Trial name
- NCT03247907
- Testing
- Condition A: CPAP with No Humidification, Condition B: CPAP with No Humidification, Condition C: CPAP with Cold Passover
- Where
- New Zealand
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Pressure Relief Algorithm Eval
The PRA Effect on APAP Therapy Pressure Study is a randomized, controlled, crossover study in PAP-adherent participants with OSA.
- Trial name
- NCT06407999
- Testing
- Expiratory Pressure Relief
- Where
- United States
- Sponsor
- SleepRes Inc.
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT02894242
- Testing
- F&P Deimos Nasal Pillows Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 22 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02730273
- Testing
- Trial Nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Sleep Apnea, Obstructive
Proof-of-Concept Study to Determine the Flow Changes When Stimulating Two Neural Targets for the Treatment of Obstructive Sleep Apnea
This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes
- Trial name
- NCT06415981
- Testing
- Hypoglossal nerve and/or Ansa Cervicalis stimulation
- Where
- United Kingdom
- Volunteers
- 7 people
- Sponsor
- Invicta Medical Inc.
Down Syndrome, Obstructive Sleep Apnea
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome…
- Trial name
- NCT04801771
- Testing
- Inspire Upper Airway Stimulation (UAS) System
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea
SleepFlexTM Treatment of Obstructive Sleep Apnea
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
- Trial name
- NCT04726514
- Testing
- SleepFlex
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Berendo Scientific, LLC
Sleep Apnea, Obstructive
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy.
- Trial name
- PBSW (NCT01031914)
- Testing
- Paced Breathing
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Philips Respironics
Atrial Fibrillation, Obstructive Sleep Apnea
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive…
- Trial name
- AFOSA (NCT04519489)
- Testing
- PAP therapy with telemonitoring, AF standard management and OSA general care
- Where
- 2 sites in China
- Volunteers
- 129 people
- Sponsor
- Philips (China) Investment CO., LTD
Obstructive Sleep Apnea
Validation of a Simplified MATRx Plus
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing.
- Trial name
- NCT03812692
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Zephyr Sleep Technologies
Obstructive Sleep Apnea
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
- Trial name
- NCT02942446
- Testing
- Investigative Headgear with CPAP mask
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Study of TAK-925 in Participants With Obstructive Sleep Apnea (OSA) Who Are Experiencing Excessive Daytime Sleepiness (EDS) Despite Adequate Use of Continuous Positive Airway Pressure (CPAP)
The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adults with obstructive sleep apnea (OSA) who are experiencing excessive daytime…
- Trial name
- NCT04091425
- Testing
- TAK-925
- Where
- 18 sites in United States
- Volunteers
- 25 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Obstructive Sleep Apnea (OSA)
INFORMing Patients With Oximetry Data to Improve MAD Engagement
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.
- Trial name
- INFORM (NCT07564310)
- Testing
- Narval MRD device, MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
- Volunteers
- 120 people
- Sponsor
- ResMed