Clinical trials: Sleep Apnea Hypopnea Syndrome
Obstructive Sleep Apnea (OSA)
INFORMing Patients With Oximetry Data to Improve MAD Engagement
Obstructive sleep apnea (OSA) is common and associated with impaired daytime functioning, reduced quality of life and increased cardiovascular, metabolic and perioperative risk.
- Trial name
- INFORM (NCT07564310)
- Testing
- Narval MRD device, MyNarval intervention (Narval CC MAD + O2 ring + MyNarval smartphone application),
- Volunteers
- 120 people
- Sponsor
- ResMed
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- NCT01532180
- Testing
- aura6000 System
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- ImThera Medical, Inc.
Mild Obstructive Sleep Apnea
MedCline Investigational Study for the Treatment of Mild OSA With Positional Therapy
The purpose of this study is to evaluate the safety and effectiveness of the MedCline Sleep System in reducing symptoms related to mild OSA.
- Trial name
- NCT07492420
- Testing
- MedCline Sleep System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Amenity Health, Inc.
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
- Trial name
- NCT03092921
- Testing
- F&P Mask Seal, F&P Mask
- Where
- New Zealand
- Volunteers
- 18 people
- Sponsor
- Fisher and Paykel Healthcare
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
Obstructive Sleep Apnea
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
- Trial name
- NCT02972970
- Testing
- Aveera
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Metamason
Sleep Apnea, Obstructive
eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA…
- Trial name
- ELMO (NCT05252156)
- Testing
- eXciteOSA
- Where
- 7 sites in United States
- Volunteers
- 62 people
- Sponsor
- Signifier Medical Technologies
Obstructive Sleep Apnea
Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment.
- Trial name
- NCT02699463
- Testing
- Continous Positive Airway Pressure, Control Group
- Where
- 11 sites in United Kingdom
- Volunteers
- 301 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3)…
- Trial name
- NCT02907398
- Testing
- Inspire therapy, No intervention
- Where
- 64 sites in United States, Belgium and 3 more
- Volunteers
- 5,000 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea, Obstructive
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline…
- Trial name
- NCT00467324
- Testing
- Aspire Medical Advance System
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Aspire Medical
Obstructive Sleep Apnea
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use.
- Trial name
- IRIS (NCT02348970)
- Testing
- ONIRIS®, TALI
- Where
- 10 sites in France
- Volunteers
- 211 people
- Sponsor
- ONIRIS
Obstructive Sleep Apnea
CPAP In-home Assessment Australia
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
- NCT02809794
- Testing
- Fisher & Paykel Healthcare CPAP Device
- Where
- 3 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea
The purpose of this study is to assess the safety of ramelteon, once daily (QD), in individuals with obstructive sleep apnea.
- Trial name
- NCT00672061
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Takeda
Sleep Apnea
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight…
- Trial name
- NCT00745251
- Testing
- VI-0521
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- VIVUS LLC
Sleep Apnea, Obstructive
Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the…
- Trial name
- NCT00750165
- Testing
- SleepStyle 200 Auto Series CPAP Humidifier
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea of Adult
An Extension Study to Assess the Long-term Safety of the Genio® System
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a…
- Trial name
- OLE (NCT05939141)
- Testing
- Genio System
- Where
- 7 sites in Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Metabolism and Nutrition Disorder, Obesity
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.
- Conditions
- Metabolism and Nutrition Disorder, Obesity, Obstructive Sleep Apnoea
- Trial name
- NCT01557166
- Testing
- liraglutide
- Where
- 42 sites in United States, Canada
- Volunteers
- 359 people
- Sponsor
- Novo Nordisk A/S
Sleep Apnea Syndromes
Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no Treatment
The sleep apnea-hypopnea syndrome is characterized by the occurrence, during sleep, of abnormally frequent episodes of interruption of ventilation (apnea), or significant reduction in ventilation (hypopnea).
- Trial name
- NCT05477719
- Testing
- Wearing of specific compression stockings
- Where
- France
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sigvaris France
Obstructive Sleep Apnea
Inspire® Upper Airway Stimulation System
The purpose of this post-market study is to assess safety and effectiveness of Inspire Upper Airway System (UAS) in a commercial setting.
- Trial name
- RCT (NCT02675816)
- Testing
- Inspire® Upper Airway Stimulation (UAS) System
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Inspire Medical Systems, Inc.
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