Clinical trials: Sleep Hypopnea
Obstructive Sleep Apnea
CPAP In-home Assessment NZ
Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
- Trial name
- NCT02804919
- Testing
- Fisher & Paykel Healthcare CPAP Device
- Where
- New Zealand
- Volunteers
- 30 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a Novel Nasal Pillows 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 nasal pillows mask amongst Obstructive Sleep Apnea…
- Trial name
- NCT03605485
- Testing
- Nasal Pillows CPAP mask
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Sleep Apnea, Obstructive
Nebula Study - Screener Apps and HSAT vs. PSG Comparison
This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.
- Trial name
- NCT04597749
- Testing
- PSG, Home Sleep Apnea Test with FDA cleared devices, Non-Contact Screening App
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ResMed
Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis)
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the…
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis), Chronic Opioid Use
- Trial name
- NCT01462084
- Testing
- Adaptive servo-ventilation (ASV), Bi-Level PAP
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- ResMed
Sleep Apnea, Sleep Apnea, Obstructive
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06635265
- Testing
- Target Stimulation (HGN, AC, GG, Strap muscles)
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Invicta Medical Inc.
Overweight and Obesity, Cardiovascular Diseases
Study Consortium for Evaluation of RNPC Program in Obese and Overweight Patients (SCOOP-RNPC)
The investigators hypothesize that weight loss obtained with the French RNPC weight reduction program is beneficial for the general health of overweight/obese patients in the medium term.
- Conditions
- Overweight and Obesity, Cardiovascular Diseases, Metabolic Disease, Diabete Type 2
- Trial name
- SCOOP-RNPC (NCT05857319)
- Testing
- Nutritional Psycho-Behavioral Reeducation Program
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Groupe Éthique et Santé
Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Evaluation of the F&P Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
- Trial name
- NCT07826429
- Testing
- F&P Licorice Mask
- Where
- United States
- Volunteers
- 45 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
Obstructive Sleep Apnea Hypopnea, OSA
Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea
Primary Endpoints: •Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs.
- Conditions
- Obstructive Sleep Apnea Hypopnea, OSA, OSAH
- Trial name
- AERO (NCT00772044)
- Testing
- Provent Professional Sleep Apnea Therapy Device
- Where
- 17 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ventus Medical, Inc.
Obstructive Sleep Apnea
Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.
The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea.
- Trial name
- NCT04018547
- Testing
- Patient wears a wrist sensor oximeter device for one to two nights.
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Oxitone Medical Ltd.
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
Heart Failure, Congestive, Sleep Apnea Syndromes
Investigation of Heart Failure Status Over Time Using Respiratory Parameters
The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.
- Trial name
- NCT00494117
- Testing
- ApneaLink
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- ResMed
Sleep Apnea, Sleep Apnea, Obstructive
Assessing the Performance of Wesper Lab for Obstructive and Central Sleep Apnea
The goal of this clinical trial is to evaluate the effectiveness of the Wesper Lab home sleep apnea test as a tool to aid in the diagnosis of sleep apnea in adult patients (age ≥21 years) who are recommended for an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea, Central
- Trial name
- NCT07095413
- Testing
- Wesper Lab Home Sleep Apnea Test
- Volunteers
- 100 people
- Sponsor
- Wesper Inc
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy
- Conditions
- Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
- Trial name
- NCT02726048
- Testing
- Simplus/Eson
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, Duke
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06351878
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Obstructive Sleep Apnea
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and…
- Trial name
- NCT02297789
- Testing
- Investigative Full Face Mask with Headgear
- Where
- New Zealand
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Post-Market Observational Study of the WINX Sleep Therapy for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).
- Trial name
- UNMASK (NCT01683721)
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- ApniCure, Inc.
Positive Airway Pressure Therapy, Obstructive Sleep Apnea
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy…
- Trial name
- NCT04615832
- Testing
- Toffee Full Face Mask
- Where
- 3 sites in New Zealand
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea Syndromes
Sleep Disordered Breathing and Chronic Pain
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
- Trial name
- NCT01457014
- Testing
- servo ventilation auto, Continuous positive airway pressure, servo ventilation manual
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- Philips Respironics