Clinical trials: Sleep Hypopnea
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
Sleep Apnea
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
- Trial name
- NCT04031950
- Testing
- Novel wearable paediatric device
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Acurable Ltd.
Sleep Disordered Breathing, Congestion, Nasal
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic…
- Trial name
- NCT03105297
- Testing
- Prototype nasal dilator strip, No strip
- Where
- Australia
- Volunteers
- 91 people
- Sponsor
- GlaxoSmithKline
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 Apnea
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
- Trial name
- MAPs (NCT01981590)
- Testing
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Where
- 2 sites in Netherlands, Sweden
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
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
Obstructive Sleep Apnea
A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance…
- Trial name
- NCT03049982
- Testing
- Auto-titrating mandibular positioner test
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Zephyr Sleep Technologies
Apnea (Central and Obstructive)
MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)
A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence.
- Trial name
- MEntA Program (NCT07258264)
- Testing
- Motivational Interviewing (MI), Competency-based learning
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Air Liquide Healthcare Spain
Sleep Apnea, Obstructive
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard…
- Trial name
- NCT01517763
- Testing
- Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a 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 full face and nasal mask amongst Obstructive Sleep…
- Trial name
- NCT03142438
- Testing
- F&P Seal Improvement Project
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
- Trial name
- NCT02972970
- Testing
- Aveera
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Metamason
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06283030
- Testing
- Hypoglossal nerve stimulation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Invicta Medical Inc.