Clinical trial NCT04234828: Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome
Official title: Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Keywords: Sleep Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Apnea
Lead sponsor: Withings
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for an in-lab PSG exam

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 Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep for the detection of SAS compared to PSG.


Eligibility criteria: Inclusion Criteria:

* adults, men or women, aged between 18 and 70
* patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing

Exclusion Criteria:

* children less than 18 years of age
* patients treated with continuous positive airway pressure
* person not giving her consent
* vulnerable subject according to current regulation:
* pregnant woman, parturient or breastfeeding
* subject deprived of freedom by judicial, medical or administrative decision
* subject legally protected or unable to express his consent
* subject non-beneficiary of healthcare
* subject falling into more than one of the above categories
* subject in linguistic or psychic incapacity to express his consent

Primary outcomes:
measure: Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG
timeFrame: immediately after intervention
measure: Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG
timeFrame: immediately after intervention
Secondary outcomes:
measure: Sensitivity and specificity of polygraphy (PG)
timeFrame: immediately after intervention
measure: Sensitivity and specificity of PG
timeFrame: immediately after intervention
measure: Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG
timeFrame: immediately after intervention
measure: Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG
timeFrame: immediately after intervention
measure: Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG
timeFrame: immediately after intervention
measure: Influence of the position of the sleeper (decubitus dorsal vs decubitus latero-ventral) on the error of the AHI predicted by Withings Sleep compared with PSG
timeFrame: immediately after intervention
measure: Impact of the proportion of hypopnea events on the performance of Withings Sleep
timeFrame: immediately after intervention
measure: Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.
timeFrame: immediately after intervention
measure: Reliability of Withings Sleep
timeFrame: immediately after intervention
measure: Reliability of PSG
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre
city: Clamart
country: France
facility: Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère
Study officials:
affiliation: Hôpital Antoine Béclère
name: Garbiel Roisman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edouard P, Campo D, Bartet P, Yang RY, Bruyneel M, Roisman G, Escourrou P. Validation of the Withings Sleep Analyzer, an under-the-mattress device for the detection of moderate-severe sleep apnea syndrome. J Clin Sleep Med. 2021 Jun 1;17(6):1217-1227. doi: 10.5664/jcsm.9168.