Sleep Apnea : Diagnosis and Monitoring (ApneaBand)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: ApneaBand

Study type: Observational

Funder types: Other

Identifiers

NCT03571477

38RC18.010

Details and patient eligibility

About

This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.

Full description

The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.

40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).

Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with moderate or severe obstructive sleep apnea (OSA), diagnosed by polygraphy or PSG for less than 2 years, and not treated for that.
• Non apneic person (Berlin score = 0 or 1)
• Person be able to use the personal health monitoring device ApneaBand
• Be legally able to give consent
• Person affiliated to social security

Exclusion criteria

• Patient already treated for OSA
• Patient equipped with an electric medical device (non-exhaustive examples: cardiac pace maker, cochlear implant, neuro-stimulator)
• Being unable to understand and to follow recommendations for the study due to cognition or language problems
• Pregnant women, feeding and parturient
• Person under administrative or judicial control, or who is protected under the act
• Person in exclusion period for another study
• Person which would perceive more than 4500 euros of compensation because of its participation in other clinical studies in 12 months preceding this study