Clinical trial NCT03571477: Sleep Apnea : Diagnosis and Monitoring
Official title: Sleep Apnea : Diagnosis and Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Sleep apnea diagnosis
Sleep apnea monitoring
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
name: AIRFAN
name: AGIR à Dom
First posted: 2018-06-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with OSA and not treated for that
* Non apneic subjects or unknown apneic subjects wishing to explore their sleep
* Different skin tones from Fitzpatrick's phototypes I to VI.

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.

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

Primary outcomes:
measure: Performance of the ApneaBand to detect sleep apnea
timeFrame: 3 days
Secondary outcomes:
measure: Performance of the ApneaBand to mesure the apnea severity
timeFrame: 3 days
measure: External reproductibility of AHI measurement by the ApneaBand
timeFrame: 3 days
measure: Internal reproductibility of AHI measurement by the ApneaBand
timeFrame: 3 days
measure: ApneaBand algorith validation for AHI measurement
timeFrame: 3 days
measure: Sleep stage detection by ApneaBand
timeFrame: 3 days
measure: Skin tone variability
timeFrame: 3 days
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Chu Grenoble-Alpes
state: Isère
Study officials:
affiliation: CHU Grenoble Alpes
name: Jean-Louis PEPIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: