Clinical trials: Obstructive Apnea
Obstructive Sleep Apnea (OSA)
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites).
- Trial name
- NCT04744038
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- 2 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- ResMed
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Obstructive Sleep Apnea
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
- Trial name
- NCT05573763
- Testing
- F&P Toffee
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a…
- Trial name
- NCT02851628
- Testing
- Alternative sizing model based trial mask, Prototype Full Face Mask
- Where
- 4 sites in New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
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.
Sleep Apnea, Obstructive
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index…
- Conditions
- Sleep Apnea, Obstructive, Obesity
- Trial name
- NCT06931028
- Testing
- IBI362
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Obesity Hypoventilation Syndrome
AVAPS-AE Efficacy Study
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV)…
- Trial name
- NCT01368614
- Testing
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP…
- Trial name
- NCT01742949
- Testing
- Heated humidification (ThermoSmart), No Humidification
- Where
- 4 sites in France
- Volunteers
- 40 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
Excessive Sleepiness
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have…
- Trial name
- NCT00711516
- Testing
- Armodafinil
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cephalon
Obstructive Sleep Apnea
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Trial name
- NCT03329352
- Testing
- F&P Full-Face Mask
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea of Adult
An Extension Study to Assess the Long-term Safety of the Genio® System
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a…
- Trial name
- OLE (NCT05939141)
- Testing
- Genio System
- Where
- 7 sites in Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.
- Trial name
- NCT04932486
- Testing
- Transcutaneous electrical stimulation
- Where
- Belgium
- Volunteers
- 42 people
- Sponsor
- Sunrise
Sleep Apnea, Obstructive
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults
Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by intermittent partial and/or complete upper airway obstruction during sleep.
- Trial name
- APAP (NCT01210261)
- Testing
- Compumedics Somnilink SPAP - Auto-titrating CPAP, Resmed Autoset S8 - Auto-titrating CPAP
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Compumedics Limited
Obstructive Sleep Apnea
Whitsundays (Nasal) Mask Take Home Study (90 Days)
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea.
- Trial name
- NCT06036329
- Testing
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Clinical Study for the BONGO Device in the Treatment of Obstructive Sleep Apnea (OSA)
Prospective, non-randomized, open label study
- Trial name
- NCT02878590
- Testing
- BONGO DEVICE
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- InnoMed Healthscience Inc.
Obstructive Sleep Apnea
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system.
- Trial name
- NCT02255539
- Testing
- Geelong Prototype Mask
- Where
- Australia
- Volunteers
- 42 people
- Sponsor
- ResMed
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
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Nasal Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants.
- Trial name
- NCT03752580
- Testing
- User Instructions of novel nasal mask
- Where
- New Zealand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Sleep, Insomnia
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT04943562
- Testing
- ACT+EEG
- Where
- 2 sites in Brazil
- Volunteers
- 96 people
- Sponsor
- SleepUp Tecnologia em Saúde Ltda