Clinical trials: Hypopnea Syndrome, open to volunteers
Sleep Apnea Syndromes
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care.
- Trial name
- SESAME (NCT06578390)
- Testing
- Apneal device
- Where
- 11 sites in France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Mitral
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 Disorder
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders.
- Trial name
- NCT06093633
- Where
- 3 sites in United States, Israel
- Volunteers
- 600 people
- Sponsor
- Itamar-Medical, Israel
Obstructive Sleep Apnea
Pediatric Post-Approval Registry
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe…
- Trial name
- NCT04457154
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea (OSA)
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
- Trial name
- AHIBMI PAS (NCT07113288)
- Testing
- Inspire® UAS System
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Inspire Medical Systems, Inc.
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.