Clinical trials: Sleep-disordered Breathing
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Sleep Disordered Breathing
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern.
- Trial name
- NCT01082575
- Testing
- Oxygen Monitoring
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Sleep Disordered Breathing, Cheyne-Stokes Respiration
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas).
- Conditions
- Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea
- Trial name
- NCT00909259
- Testing
- Phrenic stimulation device
- Where
- 5 sites in United States, China and 1 more
- Volunteers
- 50 people
- Sponsor
- Respicardia, Inc.
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Full-face Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter…
- Trial name
- NCT02938208
- Testing
- Jupiter Full Face Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
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
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
Congestive Heart Failure, Left Ventricular Systolic Dysfunction
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.
- Trial name
- SchlaHF (NCT01500759)
- Where
- 199 sites in Australia, Germany
- Volunteers
- 6,876 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous…
- Trial name
- TESLA-MICRON (NCT07343362)
- Testing
- ZeusOSA, CPAP
- Volunteers
- 186 people
- Sponsor
- Zeus Sleep Ltd
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
Sleep-Disordered Breathing
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
- Trial name
- Snoring (NCT00773591)
- Testing
- NT 201, a Botulinum neurotoxin type A, free of complexing proteins
- Sponsor
- Merz Pharmaceuticals GmbH
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Sleep-disordered Breathing, Hypercapnia
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support.
- Trial name
- NCT04926805
- Testing
- CPAP with Mask A, CPAP with Mask B
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Pregnancy Related, Sleep
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and…
- Conditions
- Pregnancy Related, Sleep, Sleep-Disordered Breathing, Sleep Disturbance
- Trial name
- SLeeP AID4 (NCT05376475)
- Testing
- Infrared video-audio camera, Level III home sleep apnea test, Maternal-fetal transabdominal electrocardiographic heart rate monitor
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 1 (NCT06883617)
- Testing
- Neuro stimulator Implant
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Sleep Apnea, Sleep Apnea, Obstructive
Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy
Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated. Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure (CPAP), entails use of a nose mask to deliver…
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disordered Breathing
- Trial name
- NCT03217383
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 75 people
- Sponsor
- Zephyr Sleep Technologies
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
Sleep Apnea, Sleep-Disordered Breathing
Alice PDx User/Validation Extended Trial
The objective of this study is to test the usability of the Alice PDx device by both the end user (patient/participant) and the sleep technician.
- Trial name
- NCT00841906
- Testing
- Alice PDx with only written instructions, Alice PDx with written and verbal instructions
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Philips Respironics
Sleep-Disordered Breathing
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
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
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