Clinical trials: Obstructive Sleep Apnea-Hypopnea Syndrome
Right to Left Shunt, Patent Foramen Ovale
Right to Left Cardiac Shunt Detection
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal…
- Conditions
- Right to Left Shunt, Patent Foramen Ovale, Atrial Septal Defect
- Trial name
- PFO Detection (NCT01773252)
- Testing
- Flow Detection System
- Where
- 8 sites in United States
- Volunteers
- 141 people
- Sponsor
- Cardiox Corporation
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea…
- Trial name
- NCT03605485
- Testing
- Nasal Pillows CPAP mask
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Fisher and Paykel Healthcare
OSA
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
- Trial name
- NCT05811247
- Testing
- AD109
- Where
- 64 sites in United States
- Volunteers
- 660 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.
- Trial name
- NCT05496062
- Testing
- F&P Toffee Nasal and Toffee Nasal Pillows Masks
- Where
- 2 sites in United States
- Volunteers
- 91 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Alesis OSA-1 Obstructive Sleep Apnea Treatment
The goal of randomized clinical trial is to determine if the Alesis OSA-1 low laser light therapy device can reduce apnea-hypopnea index scores and treat sleep apnea in adult participants over the age of 18 who are diagnosed with…
- Trial name
- OSA (NCT06949969)
- Testing
- OSA LLLT treatment device
- Where
- 2 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Photonica USA, LLC
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 Hypopnea, OSA
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs.
- Conditions
- Obstructive Sleep Apnea Hypopnea, OSA, OSAH
- Trial name
- AERO (NCT00772044)
- Testing
- Provent Professional Sleep Apnea Therapy Device
- Where
- 17 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ventus Medical, Inc.
Obstructive Sleep Apnea of Adult
Pilot Study of the CHILLS Cryotherapy System for the Treatment of OSA
This is a prospective, multicenter, non-randomized single-arm safety and efficacy study to: Collect data to evaluate the safety of CHILLS cryotherapy to treat OSA in patients with moderate to severe disease.
- Trial name
- ARCTIC-2 (NCT05542082)
- Testing
- CHILLS Procedure
- Where
- 2 sites in Panama
- Volunteers
- 22 people
- Sponsor
- Cryosa, Inc.
Sleep Apnea, Obstructive
Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography
Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and…
- Trial name
- NCT00697424
- Testing
- SleepStyle 200 Auto Series CPAP Humidifier
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea
Implantable Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
The objective of this study is to evaluate the safety and preliminary effectiveness of an implantable hypoglossal nerve stimulation system for moderate-to-severe obstructive sleep apnea (OSA).
- Conditions
- Obstructive Sleep Apnea (OSA), Syndrome, Obstructive Sleep Apnea, Respiration Disorders, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT07711678
- Testing
- Implantable Hypoglossal Nerve Stimulation System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Beijing Pins Medical Co., Ltd
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.