Clinical Trials Directory

Trials / Unknown

UnknownNCT04759482

Validation of a New Algorithm for Screening Sleep Apnea Syndrome From Electrocardiogram

Validation of an Innovative Algorithm for Screening Sleep Apnea Syndrome From an Electrocardiographic Recording During Sleep

Status
Unknown
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases The gold standard for the diagnosis of sleep apnea is the polysomnography. But polysomnography is time-consuming and very expensive. We developed an algorithm for screening sleep apnea from electrocardiographic signal. This would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. The validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (AHI) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the Center for Sleep Medicine and Research in Nancy, with the AHI resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTpolysomnographyPolysomnography consisted in recording sleep parameters during one night, using a non-invasive multi-channels device, including respiratory sensors, electrocardiogram and electroencephalogram

Timeline

Start date
2021-03-01
Primary completion
2021-04-01
Completion
2021-05-01
First posted
2021-02-18
Last updated
2021-02-18

Source: ClinicalTrials.gov record NCT04759482. Inclusion in this directory is not an endorsement.