Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

Sleep Apnea Clinical Trial

— VPASH  

Official title:

Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496843
• Other study ID #: 2019-A01347-50
• Status: Recruiting
• Start date: January 16, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2020
• Source: Withings
• Contact: Delphine Ladarré, PhD
• Phone: +33 6 75 12 23 80
• Email: delphine.ladarre[@]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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• HWA09 Measurement
Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.

Locations

Country	Name	City	State
Belgium	St Pierre Hospital	Brussels
France	Antoine Béclère Hospital	Clamart	Ile-de-France

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 HWA09 at AHI threshold value of 5/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.	1 year
Primary	Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.	1 year
Primary	Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG	Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.	1 year
Secondary	Sensitivity and Specificity of the desaturation detected by Withings HWA09	Sensitivity and specificity of the desaturation detection by Withings HWA09 compared to an oximeter with the Oxygen Desaturation Index (ODI)	1 year
Secondary	Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG	Bias and mean absolute error (MAE)	1 year
Secondary	Impact of the proportion of apnea events on the performance of Withings HWA09	Bias and MAE for apnea index (AI) estimated by Withings HWA09 compared to PSG results	1 year
Secondary	Impact of the proportion of hypopnea events on the performance of Withings HWA09	Bias and MAE for hypopnea index (HI) estimated by Withings HWA09 compared to PSG results	1 year
Secondary	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	Average difference of AHI between Withings HWA09 and the PSG in each position	1 year
Secondary	Reliability of Withings HWA09	Rate of unusable of lost nights	1 year