Sleep Apnea : Diagnosis and Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sleep Apnea : Diagnosis and Monitoring

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: ApneaBand


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ApneaBand|Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the ApneaBand to detect sleep apnea | 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 | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the ApneaBand to mesure the apnea severity | 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 | 3 days | 
| External reproductibility of AHI measurement by the ApneaBand | Reproducibility between AHI from polysomnography and ApneaBand | 3 days | 
| Internal reproductibility of AHI measurement by the ApneaBand | Reproducibility between different AHI mesures from ApneaBand | 3 days | 
| ApneaBand algorith validation for AHI measurement | External validation of the ApneaBand algorithm | 3 days | 
| Sleep stage detection by ApneaBand | To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages | 3 days | 
| Skin tone variability | To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea diagnosis, Sleep apnea monitoring