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

NCT ID: NCT04759482

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

polysomnography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

El Mehdi Siaghy

Role: STUDY_CHAIR

Research and Innovation Department

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicolas Carpentier

Role: CONTACT

0033383858585

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020PI046

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Apnea Screening
NCT02569749 TERMINATED