Status:
UNKNOWN
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
Lead Sponsor:
Withings
Conditions:
Sleep Apnea
Eligibility:
All Genders
18-70 years
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 t...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2021
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04496843
Start Date
January 16 2020
End Date
January 31 2021
Last Update
August 3 2020
Active Locations (2)
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1
St Pierre Hospital
Brussels, Belgium, 1000
2
Antoine Béclère Hospital
Clamart, Île-de-France Region, France, 92140