Clinical trials: Apnea
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 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
Obstructive Sleep Apnea
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.
- Trial name
- NCT04028011
- Testing
- Novel Wearable device
- Where
- Spain
- Volunteers
- 150 people
- Sponsor
- Acurable Ltd.
Obstructive Sleep Apnea
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
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
Sleep Apnea
Janus II Feasibility
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
- Trial name
- NCT06556693
- Testing
- Dual Channel Stimulation
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Mild-Moderate Obstructive Sleep Disordered Breathing
Non-Inferiority Trial of Acute HFT Versus nCPAP
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
- Trial name
- NCT01860560
- Testing
- High-Flow Therapy, Continuous Positive Airway Pressure
- Where
- United States
- Sponsor
- Vapotherm, Inc.
Obstructive Sleep Apnea
Nexus Compliance Study
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP).
- Trial name
- NCT01013207
- Testing
- CPAP Pre Nexus (S9), Nexus (S9), CPAP Post Nexus (S9)
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- ResMed
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
Apnea, Bradycardia
microEEG for Neonatal Apnea, Bradycardia and Desaturation
The study utilizes microEEG (a novel miniaturized, FDA approved EEG device) to prospectively investigate the cerebral electrical activity of infants with Apnea, Bradycardia and Desaturation events.
- Conditions
- Apnea, Bradycardia, Premature Birth, Seizures
- Trial name
- NCT02436616
- Testing
- microEEG
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Bio-Signal Group Corp.
Obstructive Sleep Apnea (OSA) and Obesity
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP)…
- Trial name
- NCT07794397
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy.
- Trial name
- NCT01421654
- Testing
- S9 Elite with Acclimate, S9 Elite
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- 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.
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Sleep Apnea, Sleep Apnea Syndromes in Children
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- Trial name
- NCT06218186
- Testing
- Medical Device: Wesper Lab Home Sleep Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Wesper Inc
Sleep, Sleep Apnea
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients
This study aims to evaluate the accuracy of apnea detection and automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a…
- Trial name
- NCT03657329
- Testing
- Dreem
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Dreem
Airway Obstruction, Apnea
Effectiveness of Continuous Negative External Pressure in Preventing Upper Airway Impairment During Routine Colonoscopy
The primary goal of this study is to determine the effectiveness and safety of delivering continuous negative external pressure (cNEP) to the upper airway as a means of preventing episodes of respiratory impairment (RI) such as…
- Conditions
- Airway Obstruction, Apnea, Hypopnea
- Trial name
- NCT01895062
- Testing
- Airway Management System (AMS)
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- 5i Sciences, Inc.
Obstructive Sleep Apnea (OSA)
Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
This study will take between 1-2 months (with first patient first visit to last patient last visit). Each participant will use the supplied PAP device and mask for a period of up to 14 nights.
- Trial name
- NCT04741854
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- Australia
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ResMed
Excessive Daytime Sleepiness, Narcolepsy
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, Chronic Shift Work Sleep Disorder
- Trial name
- NCT00228553
- Testing
- Armodafinil 100 to 250 mg/day
- Where
- 100 sites in United States, Australia and 5 more
- Volunteers
- 743 people
- Sponsor
- Cephalon