Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Apnea Syndromes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients referred for an overnight in-lab PSG<br>Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG | Bias and mean absolute error (MAE) | immediately after intervention | 
| Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG | Bias and MAE | immediately after intervention | 
| Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG | Bias and MAE | immediately after intervention | 
| 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 | 
| 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 | 
| 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 | 
| Reliability of Withings Sleep | Rate of unusable or lost nights. | immediately after intervention | 
| Reliability of PSG | Rate of unusable or lost nights. | immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnea, 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