Clinical trials: Sleep Disordered Breathing (SDB)
Sleep-Disordered Breathing, Obstructive Sleep Apnea
A Multi-Center Study to Assess the Performance of Saturation Patterns.
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.
- Conditions
- Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00775346
- Where
- 3 sites in United States
- Volunteers
- 92 people
- Sponsor
- Medtronic - MITG
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
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.
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
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.
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 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
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
- Trial name
- NCT05647746
- Testing
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Where
- Australia
- Volunteers
- 108 people
- Sponsor
- Compumedics Limited
Heart Failure, Congestive, Sleep Apnea Syndromes
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
- Trial name
- NCT00493948
- Testing
- ApneaLink
- Where
- Australia
- Volunteers
- 35 people
- Sponsor
- ResMed
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
Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography.
- Trial name
- NCT02368639
- Testing
- Fisher & Paykel Healthcare PAP Device
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
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.
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
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
Sleep Apnea, Central Sleep Disordered Breathing
The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e.
- Trial name
- TREAT-CSA (NCT02577445)
- Where
- 10 sites in Germany, Spain
- Volunteers
- 31 people
- Sponsor
- LivaNova