Comparing cardiac variability in sleep apnea and healthy individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze cardiac variability in patients with severe sleep apnea syndrome (SAS) compared to healthy individuals. The research focuses on measuring variations in cardiac variability during REM sleep, a critical phase for sleep apnea risk. By employing a machine learning system, the study seeks to establish a reliable and accessible screening method for SAS in outpatient settings. The methodology will also extend to other sleep phases and correlate findings with established cardiac variability markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Group healthy subjects - 1): absence of sleep disorder referenced in the ICSD-3.

  * Epworth Sleep Scale \< 11
  * Pittsburgh Quality Sleep Index \< 6
  * Berlin Questionnaire: \< 2 positive categories
  * STOP BANG \<3
  * HADS normal
  * No RLS
* Group 2 (subjects with severe SAS - 2): AHI \> 30/h obstructive

Exclusion Criteria:

Non-inclusion criteria:

* Cardiac rhythm disorder
* Neurological or psychiatric pathology impacting on ANS
* Control group (healthy subjects - 1)

  * Complaint of sleep disorder
  * Known sleep disorder
* Experimental group (subjects with severe SAS - 2):

  o Associated sleep pathology at diagnosis of severe SAS
* Administrative reasons:

  * Unable to receive informed information,
  * Unable to participate in the entire study
  * Lack of social security coverage
  * Refusal to sign consent Exclusion criteria
* Control group (healthy subjects - 1):

  * Sleep pathology detected by polysomnography
  * Total sleep time less than 4 hours
  * Recording technically not usable

Where it's running

• Service de Neurophysiologie - unité de médecine du Sommeil - CHU Lille
  Lille, France Recruiting

Study contacts

• Principal investigator: Philippe DERAMBURE, MD — University Hospital, Lille
• Study coordinator: Philippe DERAMBURE, PR
• Email: Philippe.DERAMBURE@chu-lille.fr
• Phone: 0320445962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.