Clinical trials: Sleep-disordered Breathing (SDB)
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.
Obstructive Sleep Apnea Syndrome
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in…
- Trial name
- NCT00086281
- Testing
- Xyrem (X), Zolpidem (Z), Modafinil (M)
- Where
- 2 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Jazz Pharmaceuticals
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 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
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
Perennial Allergic Rhinitis, Obstructive Sleep Apnea
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated…
- Conditions
- Perennial Allergic Rhinitis, Obstructive Sleep Apnea, Sleep Disorder
- Trial name
- NCT00359216
- Testing
- Mometasone furoate nasal spray
- Volunteers
- 30 people
- Sponsor
- Organon and Co
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 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
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.
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
Chronic Heart Failure
Adaptive Servo-ventilation Monitoring Study
Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients.
- Trial name
- NCT02133859
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- ResMed
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
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 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
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
Sleep Disordered Breathing, Congestive Heart Failure
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
- Trial name
- NCT02152566
- Testing
- Nasal High flow therapy device
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing (SDB)
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 2 (NCT07243405)
- Testing
- Neuro stimulator implant
- Where
- Panama
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
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
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
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