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NCT04759482 Clinical Trial

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

Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04759482
Other study ID # 2020PI046
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date May 1, 2021

Study information
Verified date February 2021
Source Central Hospital, Nancy, France
Contact Nicolas Carpentier
Phone 0033383858585
Email n.carpentier@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date May 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients with a polysomnography recorded in the Center for Sleep Medecine and Research (CSMR) in Nancy from january 2019 and june 2020 - results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (AHI) superior to 5 Exclusion Criteria: - refusal to participate

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• polysomnography
Polysomnography consisted in recording sleep parameters during one night, using a non-invasive multi-channels device, including respiratory sensors, electrocardiogram and electroencephalogram

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome
Type Measure Description Time frame Safety issue
Primary Concordance of the number of sleep hypopnea and apnea between an algorithm computerizing the electrocardiographic signal and the standard interpretation of the polysomnography by an expert in sleep scoring (gold standard) 18 months
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