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

NCT04759482 | Unknown DMC

• 1 other identifier: 2020PI046
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Sleep Apnea

Keywords

sleep; electrocardiogram; screening; apnea; polysomnography; algorithm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with sleep apnea

We selected 150 patients recorded by polysomnography between january 2019 and june 2020 in the Center for Sleep Medecine and Research in Nancy.

Diagnostic Test: polysomnography

Interventions

polysomnography DIAGNOSTIC_TEST

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

Patients with sleep apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient refered to the CSMR, for which sleep apnea are supected

You may qualify if:

• 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

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Apnea

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• El Mehdi Siaghy

  Research and Innovation Department

  STUDY CHAIR

Central Study Contacts

Nicolas Carpentier

CONTACT

0033383858585; n.carpentier@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 18, 2021

Record last verified: 2021-02