Clinical trials: Obstructive Apnea
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
Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).
- Trial name
- UNMASK (NCT01683721)
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- ApniCure, Inc.
Positive Airway Pressure Therapy, Obstructive Sleep Apnea
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy…
- Trial name
- NCT04615832
- Testing
- Toffee Full Face Mask
- Where
- 3 sites in New Zealand
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
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
Metabolic Syndrome, Obesity Hypoventilation Syndrome
Obesity-hypoventilation in Metabolic Syndrom Patients
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
- Conditions
- Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography
- Trial name
- NCT04839419
- Where
- France
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- SOS Oxygene Mediterranee
Obstructive Sleep Apnea (OSA)
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance.
- Trial name
- NCT02214238
- Testing
- PAP device
- Where
- New Zealand
- Volunteers
- 49 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea, Sleep Apnea
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
- Trial name
- CO-STAR (NCT05608486)
- Testing
- aerSleep II
- Sponsor
- Sommetrics, Inc.
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Obstructive Sleep Apnea
AD109 Dose Finding in Mild to Moderate OSA
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
- Trial name
- NCT04631107
- Testing
- AD109 dose1- A, AD109 dose2- B
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)
The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.
- Trial name
- SEMSAS (NCT04894175)
- Where
- France
- Volunteers
- 302 people
- Sponsor
- Thibaut Gentina
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
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
Sleep Apnea, Obstructive
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome.
- Trial name
- HYPNOS (NCT03300037)
- Testing
- Kinesthetic stimulation
- Where
- 5 sites in France
- Volunteers
- 46 people
- Sponsor
- LivaNova
OSAS (Obstructive Sleep Apneas Syndrome)
ISIS 1 Therapeutic Effectiveness
The study is a prospective field evaluation to assess the therapeutic value of the CPAP/autoCPAP Sandman in 24 new diagnosed Obstructive Sleep Apneic patients.
- Trial name
- NCT00646477
- Testing
- titration night
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Tyco Healthcare Group
Obstructive Sleep Apnea, Nasal Congestion
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2.
- Conditions
- Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion
- Trial name
- Thermosmart (NCT00665977)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Clayton Sleep Insititute
Obstructive Sleep Apnea
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask.
- Trial name
- NCT02121912
- Testing
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow CPAP mask
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery.
- Trial name
- PREDICTOR (NCT05428839)
- Testing
- Pharyngeal width measurement
- Where
- 10 sites in United States
- Volunteers
- 300 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea, Sleep Apnea
Severe OSA Study (SOS)
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
- Trial name
- NCT05445869
- Testing
- ProSomnus® EVO Sleep and Snore Device
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- ProSomnus Sleep Technologies
Obesity Hypoventilation Syndrome
Obesity Hypoventilation Syndrome Prevalence Study
This is an observational study to characterize the prevalence of Obesity Hypoventilation Syndrome in patients referred to the sleep lab.
- Trial name
- NCT01964339
- Testing
- BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study., BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Philips Respironics