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Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome (VPASS)

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ClinicalTrials.gov Identifier: NCT04234828
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Withings

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.


Condition or disease
Sleep Apnea Syndromes

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of the Diagnostic Performance of the Withings Sleep Device in Detecting Sleep Apnea Syndrome
Actual Study Start Date : July 3, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
Patients referred for an overnight in-lab PSG
Simultaneous assessment of SAS with Withings Sleep Device and overnight PSG



Primary Outcome Measures :
  1. Sensitivity and specificity of Withings Sleep at AHI threshold value of 15/h in PSG [ Time Frame: immediately after intervention ]
    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.

  2. Sensitivity and specificity of Withings Sleep at AHI threshold value of 30/h in PSG [ Time Frame: immediately after intervention ]
    Sensitivity and specificity for SAS detection by Withings Sleep compared to PSG at AHI threshold value of 30/h in PSG.


Secondary Outcome Measures :
  1. Sensitivity and specificity of polygraphy (PG) [ Time Frame: immediately after intervention ]
    Sensitivity and specificity for SAS detection by polygraphy (PG) compared to PSG at AHI threshold values of 15/h in PSG.

  2. Sensitivity and specificity of PG [ Time Frame: immediately after intervention ]
    Sensitivity and specificity for SAS detection by PG compared to PSG at AHI threshold values of 30/h in PSG.

  3. Accuracy of Withings Sleep to estimate total sleep time (TST) given by PSG [ Time Frame: immediately after intervention ]
    Bias and mean absolute error (MAE)

  4. Accuracy of Withings Sleep to estimate sleep efficiency (SE) given by PSG [ Time Frame: immediately after intervention ]
    Bias and MAE

  5. Accuracy of Withings Sleep to estimate wake after sleep onset (WASO) given by PSG [ Time Frame: immediately after intervention ]
    Bias and MAE

  6. 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 [ Time Frame: immediately after intervention ]
    Mean group difference between sleepers more than 50% of TST in decubitus dorsal or not.

  7. Impact of the proportion of hypopnea events on the performance of Withings Sleep [ Time Frame: immediately after intervention ]
    Mean group difference between patients with a majority of apnea events and patients with a majority of hypopnea events.

  8. Mean group difference between patients with central or mixed apnea and patients with obstructive apnea events. [ Time Frame: immediately after intervention ]
    Mean group difference between patients with a majority of central or mixed apnea events and patients with a majority of obstructive apnea events.

  9. Reliability of Withings Sleep [ Time Frame: immediately after intervention ]
    Rate of unusable or lost nights.

  10. Reliability of PSG [ Time Frame: immediately after intervention ]
    Rate of unusable or lost nights.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for an in-lab PSG exam
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234828


Contacts
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Contact: David Campo +33 1 41 46 04 60 david.campo@withings.com
Contact: Pierre Escourrou, PhD +33 6 81 71 79 03 pierre.escourrou@aphp.fr

Locations
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Belgium
Service de pneumologie - Laboratoire du sommeil - CHU St-Pierre Active, not recruiting
Brussels, Belgium, 1000
France
Service Explorations Fonctionnelles - Centre de Médecine du Sommeil - Hôpital Antoine Béclère Recruiting
Clamart, France, 92140
Contact: Pierre Escourrou    +33 6 81 71 79 03    pierre.escourrou@aphp.fr   
Principal Investigator: Gabriel Roisman         
Sub-Investigator: Michel Petitjean         
Sponsors and Collaborators
Withings
Investigators
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Principal Investigator: Garbiel Roisman Hôpital Antoine Béclère

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Responsible Party: Withings
ClinicalTrials.gov Identifier: NCT04234828    
Other Study ID Numbers: 2019-A00977-50
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Withings:
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
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases