Clinical trial NCT04496843: Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
Official title: Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for an in-lab polysomnography

Brief summary: Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals: movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the present study is to validate the diagnostic performance of the Withings HWA09 for the detection of SAS compared to PSG.

Detailed description: Subjects are patients having a prescription for a one-night polysomnographic consultation in order to diagnose potential sleep disorders. The investigator will collect the consent before including any patient in this study. The study last one night per patient, during which saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch, in comparison to the polysomnography.

Eligibility criteria: Inclusion Criteria:

* Adults, men and women, between 18 and 70 y/o
* Patient addressed for a polysomnography because of a suspicion of sleep respiratory disorders
* Subject having expressed his/her consent to take part in the study

Exclusion Criteria:

* Recording under continuous positive pressure
* Subject having refuse to give his/her consent
* Vulnerable subjects according to regulation in force :
* Pregnant, parturient or breastfeeding women
* Subjects having a known allergy to one of the components of the sensor (silicon, stainless steel, sapphire glass)
* Subjects deprived of liberty by a court, medical or administrative order
* Subjects legally protected or unable to express their non-opposition to take part in the study
* Subjects unable to express their consent due to linguistic or mental incapacities

Primary outcomes:
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG
timeFrame: 1 year
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG
timeFrame: 1 year
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity and Specificity of the desaturation detected by Withings HWA09
timeFrame: 1 year
measure: Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG
timeFrame: 1 year
measure: Impact of the proportion of apnea events on the performance of Withings HWA09
timeFrame: 1 year
measure: Impact of the proportion of hypopnea events on the performance of Withings HWA09
timeFrame: 1 year
measure: Influence of the position of the sleeper (supine vs prone/lateral decubitus position) on the error of the AHI predicted by Withings HWA09 compared with PSG
timeFrame: 1 year
measure: Reliability of Withings HWA09
timeFrame: 1 year
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: St Pierre Hospital
city: Clamart
country: France
facility: Antoine Béclère Hospital
state: Ile-de-France
Study officials:
affiliation: Antoine Béclère Hospital
name: Gabriel Roisman
role: PRINCIPAL_INVESTIGATOR
References: