Clinical trials: Sleep Hypopnea
Sleep Disordered Breathing, Sleep Hypopnea
Apnea Hypopnea Index Severity Versus Head Position During Sleep
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
- Conditions
- Sleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea, Sleep Apnea, Obstructive
- Trial name
- NCT04086407
- Testing
- Dual-axis inclinometer attached to the subject's forehead with tape
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sleep Systems
Sleep Apnea Syndromes, Insomnia
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire
The study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial "triage" of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea…
- Conditions
- Sleep Apnea Syndromes, Insomnia, Insufficient Sleep Syndrome, Circadian Rhythm Disorders
- Trial name
- NCT03468400
- Where
- 2 sites in United States, Israel
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Dayzz Live Well Ltd.
Obstructive Sleep Apnea, Sleep Apnea Syndromes
Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Trial name
- APNEAL-PMCF (NCT07809633)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Mitral
Sleep Apnea, Obstructives, Sleep Apnea Central
Development of a Torso Patch Sensor (C-TraQ) as a Companion Device to a Fingertip Sensor (TipTraQ) for Direct Monitoring of Respiratory Effort
The existing PranaQ system utilizes a fingertip sensor that captures PPG(Photoplethysmography) and accelerometer data, and its clinical validation is well-established.
- Trial name
- NCT07744854
- Where
- Taiwan
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Heart Failure, Sleep Disordered Breathing
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic…
- Trial name
- Serve-HF (NCT00733343)
- Testing
- Europe: AutoSet CS (USA: VPAP Adapt SV)
- Where
- 267 sites in Australia, Czechia and 9 more
- Volunteers
- 1,325 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Obstructive Sleep Apnea (OSA)
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe…
- Trial name
- NCT07021833
- Testing
- Cryosa Procedure
- Sponsor
- Cryosa, Inc.
Cardiac Diseases, Muscular Weakness
Biomarker for Pompe Disease (BioPompe)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe disease from blood (plasma)
- Conditions
- Cardiac Diseases, Muscular Weakness, Hepato-splenomegaly, Lung Disease
- Trial name
- BioPompe (NCT01457443)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Obstructive Sleep Apnea Syndrome
Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)
The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea…
- Trial name
- ORCADES (NCT01326143)
- Testing
- ORM Narval MRD
- Where
- 26 sites in France
- Volunteers
- 360 people
- Sponsor
- ResMed
Obstructive Sleep Apnea (OSA)
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites).
- Trial name
- NCT04744038
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- 2 sites in United States, Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- ResMed
Excessive Daytime Sleepiness
A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA
The objective of this study is to demonstrate the efficacy and safety of pitolisant versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep…
- Trial name
- NCT05223166
- Testing
- Pitolisant
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Citrine Medicine Limited
Sleep Apnea
Evaluation of Compumedics "Somfit" Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
- Trial name
- NCT04326127
- Testing
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
Obstructive Sleep Apnea
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
- Trial name
- NCT05573763
- Testing
- F&P Toffee
- Where
- United States
- Volunteers
- 40 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
Down Syndrome, Obstructive Sleep Apnea
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome…
- Trial name
- NCT04801771
- Testing
- Inspire Upper Airway Stimulation (UAS) System
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea, Obstructive
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index…
- Conditions
- Sleep Apnea, Obstructive, Obesity
- Trial name
- NCT06931028
- Testing
- IBI362
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Obesity Hypoventilation Syndrome
AVAPS-AE Efficacy Study
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV)…
- Trial name
- NCT01368614
- Testing
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP…
- Trial name
- NCT01742949
- Testing
- Heated humidification (ThermoSmart), No Humidification
- Where
- 4 sites in France
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Obesity
BLOOM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of…
- Trial name
- NCT00395135
- Testing
- Lorcaserin 10 mg BID
- Where
- United States
- Volunteers
- 3,182 people
- Sponsor
- Eisai Inc.
OSA
Parallel Arm Trial of AD109 and Placebo With Patients With OSA (LunAIRo)
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 1-year Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
- Trial name
- NCT05811247
- Testing
- AD109
- Where
- 64 sites in United States
- Volunteers
- 660 people
- Sponsor
- Apnimed