Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

Sleep Apnea Syndromes Clinical Trial

— VPASS  

Official title:

Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04234828
• Other study ID #: 2019-A00977-50
• Status: Recruiting
• Start date: July 3, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: January 2020
• Source: Withings
• Contact: David Campo
• Phone: +33 1 41 46 04 60
• Email: david.campo[@]withings.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Syndrome

Locations

Country	Name	City	State
Belgium	Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre	Brussels
France	Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG	Sensitivity and specificity for SAS detection by Withings Sleep compared to polysomnography (PSG) at apnea-hypopnea index (AHI) threshold value of 15/h in PSG.	immediately after intervention
Primary	Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG	Sensitivity and specificity for SAS detection by Withings Sleep compared to PSG at AHI threshold value of 30/h in PSG.	immediately after intervention
Secondary	Sensitivity and specificity of polygraphy (PG)	Sensitivity and specificity for SAS detection by polygraphy (PG) compared to PSG at AHI threshold values of 15/h in PSG.	immediately after intervention
Secondary	Sensitivity and specificity of PG	Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.	immediately after intervention
Secondary	Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG	Bias and mean absolute error (MAE)	immediately after intervention
Secondary	Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG	Bias and MAE	immediately after intervention
Secondary	Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG	Bias and MAE	immediately after intervention
Secondary	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	Mean group difference between sleepers more than 50% of TST in decubitus dorsal or not.	immediately after intervention
Secondary	Impact of the proportion of hypopnea events on the performance of Withings Sleep	Mean group difference between patients with a majority of apnea events and patients with a majority of hypopnea events.	immediately after intervention
Secondary	Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events.	Mean group difference between patients with a majority of central or mixed apnea events and patients with a majority of obstructive apnea events.	immediately after intervention
Secondary	Reliability of Withings Sleep	Rate of unusable or lost nights.	immediately after intervention
Secondary	Reliability of PSG	Rate of unusable or lost nights.	immediately after intervention