Clinical trials: Obstructive Apnea
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06283030
- Testing
- Hypoglossal nerve stimulation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Invicta Medical 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
CPAP Device In-lab Assessment NZ
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
- Trial name
- NCT02948010
- Testing
- Auto CPAP + comfort feature A, Auto CPAP with comfort feature B, Auto CPAP with no comfort feature
- Where
- New Zealand
- Volunteers
- 104 people
- Sponsor
- Fisher and Paykel Healthcare
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing.
- Trial name
- NCT06972589
- Testing
- Investigational Mask, Conventional mask
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
DeVilbiss AutoAdjust With SmartFlex Comparative Study
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Trial name
- NCT01203956
- Testing
- SmartFlex, Standard
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- DeVilbiss Healthcare LLC
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Obstructive Sleep Apnea
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
- Trial name
- DREAM (NCT03868618)
- Testing
- Genio™ system
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 115 people
- Sponsor
- Nyxoah S.A.
Snoring, Obstructive Sleep Apnea
Safety, and Tolerability of the ZENS Device (PLUTO)
The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea.
- Trial name
- NCT04063917
- Testing
- ZENS
- Where
- 2 sites in Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Zennea Technologies Inc.
Obstructive Sleep Apnea of Adult
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep…
- Trial name
- NCT03048604
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 3 sites in Australia, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Nyxoah S.A.
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 (OSA)
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
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
- NCT00773721
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Obstructive Sleep Apnea
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep…
- Trial name
- NCT03230877
- Testing
- Toffee full face mask with 'Improved Seal', Toffee full face mask with 'Normal Seal'
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
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
Obese, Sleep Apnea, Obstructive
Eval EarlySense Bet Lowenstein Sleeplab
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs.
- Conditions
- Obese, Sleep Apnea, Obstructive, Central Apnea, Sleep Disorders
- Trial name
- NCT01978340
- Where
- Israel
- Volunteers
- healthy volunteers welcome
- Sponsor
- EarlySense Ltd.
Obstructive Sleep Apnoea (OSA)
Assessment of the Performance of a New Reduced Noise Mask Vent
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent.
- Trial name
- NCT01575210
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 31 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Investigative Headgear With CPAP Mask
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.
- Trial name
- NCT02323035
- Testing
- Headgear
- Where
- New Zealand
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA…
- Trial name
- ATLAST (NCT01146782)
- Testing
- Attune Sleep Apnea System
- Where
- 6 sites in United States
- Volunteers
- 367 people
- Sponsor
- ApniCure, Inc.
Obstructive Sleep Apnea
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM
- Trial name
- PoP IN VAuto (NCT02930460)
- Where
- 8 sites in France
- Volunteers
- 30 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA…
- Trial name
- NCT03075722
- Testing
- Saturn nasal mask
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare