Clinical trials: Sleep-disordered Breathing
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
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
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
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
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
Chronic Heart Failure, Central Sleep Apnea
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation…
- Trial name
- FACE (NCT01831128)
- Testing
- ASV Treatment
- Where
- 18 sites in France
- Volunteers
- 509 people
- Sponsor
- ResMed
Heart Failure (HF)
SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions…
- Trial name
- NCT02301689
- Where
- Germany
- Volunteers
- 4,749 people
- Sponsor
- ResMed
Central Sleep Apnea, Complex Sleep Apnea
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions.
- Conditions
- Central Sleep Apnea, Complex Sleep Apnea, Obstructive Sleep Apnea, Mixed Sleep Apnea
- Trial name
- READ-ASV (NCT03032029)
- Testing
- Adaptive Servo-Ventilation
- Where
- 29 sites in Denmark, France and 4 more
- Volunteers
- 847 people
- Sponsor
- ResMed
Breathing-Related Sleep Disorder
A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- STOP-BBACK (NCT02446769)
- Testing
- AVAPS-AE Non-invasive ventilation therapy
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Philips Respironics
Snoring, OSA - Obstructive Sleep Apnea
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites.
- Trial name
- NCT07613281
- Testing
- Palatal Implant System
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Serene Sleep, Inc.
Sleep Apnea
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed
Sleep Disordered Breathing (SDB), Sleep Apnea
Detection of Sleep Stages and Arousals Using Neural Network Classifiers
The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1/N2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the…
- Trial name
- SSAM (NCT07136272)
- Testing
- SSAM, Polysomnography, EnsoSleep
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Obstructive Sleep Apnea Syndrome
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
The goal of this trial is to assess the performance of the OxiplexTS-an absolute near-infrared oximeter-as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of…
- Trial name
- NIRS-OSAS (NCT00591591)
- Testing
- OxiplexTS
- Where
- 4 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- ISS, Inc.
Sleep-disordered Breathing
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Trial name
- NCT03470493
- Testing
- ApneaLink Air
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
- Trial name
- NCT01799265
- Testing
- Somnetics Transcend Auto, Respironics REMstar Auto with C-Flex
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Somnetics International, Inc.
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF)
Clinical Trials for Elderly Patients With Multiple Disease
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other…
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
- Trial name
- CHROMED (NCT01960907)
- Testing
- CHROMED monitoring system
- Where
- 6 sites in Estonia, Slovenia and 3 more
- Volunteers
- 312 people
- Sponsor
- Restech Srl
Insomnia, Sleep-Disordered Breathing
CPAP vs ASV for Insomnia
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
- Trial name
- P2P (NCT02365064)
- Testing
- AirCurve 10 ASV
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- ResMed