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Search / Trial NCT06808464

New Approach in the Study of the Autonomic Nervous System Through Cardiac Variability in Sleep Apnea Syndrome.

Launched by UNIVERSITY HOSPITAL, LILLE · Jan 29, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Sleep Apnea Hypopnea Syndrome Autonomic Nervous System Cardiac Variability Automatic Detection Machine Learning

ClinConnect Summary

This clinical trial is looking at how the autonomic nervous system, which helps control bodily functions like heart rate, behaves in people with severe sleep apnea compared to healthy individuals. The researchers will focus on measuring heart rate variations during different stages of sleep, especially during REM sleep when sleep apnea episodes are most likely to occur. By studying these differences, the aim is to develop a simpler and more effective way to screen for sleep apnea using advanced technology.

To be eligible for this study, participants must be between the ages of 65 and 75 and fall into one of two groups: healthy individuals without any sleep disorders or those diagnosed with severe sleep apnea, which means they experience more than 30 breathing interruptions per hour during sleep. Participants can expect to undergo sleep studies and heart monitoring to help researchers gather important information. This trial is not yet recruiting participants, but it promises to contribute valuable insights into better diagnosing and understanding sleep apnea in the future.

Gender

ALL

Eligibility criteria

  • 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

About University Hospital, Lille

University Hospital Lille is a leading academic medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to enhancing therapeutic options and improving patient outcomes, University Hospital Lille collaborates with researchers, healthcare professionals, and industry partners to ensure rigorous scientific standards and ethical practices in all clinical trials.

Locations

Lille, , France

Patients applied

0 patients applied

Trial Officials

Philippe DERAMBURE, MD

Principal Investigator

University Hospital, Lille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported