Sleep Apnea : Diagnosis and Monitoring
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Performance of the ApneaBand to detect sleep apnea
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Performance of the ApneaBand to detect sleep apnea
Time Frame: 3 days
Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG
Secondary Outcomes
- Performance of the ApneaBand to mesure the apnea severity(3 days)
- Internal reproductibility of AHI measurement by the ApneaBand(3 days)
- ApneaBand algorith validation for AHI measurement(3 days)
- Skin tone variability(3 days)
- External reproductibility of AHI measurement by the ApneaBand(3 days)
- Sleep stage detection by ApneaBand(3 days)