Sleep Apnea : Diagnosis and Monitoring
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT03571477
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance of the ApneaBand to detect sleep apnea 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 Outcome Measures
Name Time Method Performance of the ApneaBand to mesure the apnea severity 3 days Performance of the ApneaBand device in detecting sleep apnea according to its severity (2 pre-specified thresholds of AHI: \> 5 and ≥ 30), in comparison with PSG
Internal reproductibility of AHI measurement by the ApneaBand 3 days Reproducibility between different AHI mesures from ApneaBand
ApneaBand algorith validation for AHI measurement 3 days External validation of the ApneaBand algorithm
Skin tone variability 3 days To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones
External reproductibility of AHI measurement by the ApneaBand 3 days Reproducibility between AHI from polysomnography and ApneaBand
Sleep stage detection by ApneaBand 3 days To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages
Trial Locations
- Locations (1)
Chu Grenoble-Alpes
🇫🇷La Tronche, Isère, France