MedTrace Logo

19/5000 (SYNAPSOT21) Predictive Factors of Sleep Apnea Syndrome in Down Syndrome

NCT03445962 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-12-29

No results posted yet for this study

Summary

The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.

The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.

OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.

Conditions

  • Down Syndrome
  • Sleep Apnea, Obstructive
  • Polysomnography

Interventions

DIAGNOSTIC_TEST

Assessment of OSAS predictive factors

All subjects of the two groups realized the same assessment: * Anthropometric evaluation * biological examination (hormonal, inflammatory and complete blood count, and lipidic profile) * rest electrocardiogram * motor assessment (strenght, flexibility and balance) * actigraphy * Autonomic nervous system assessment during sleep * Autonomic nervous system assessment during head up tilt test before and after physical exercise * maximal treadmill test (VO2 max measure) * polysomnography * seismocardiography * questionnaires :sleep and physical activity

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Stéphane DOUTRELEAU, MD · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2019-07-11
Completion
2019-07-11

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445962 on ClinicalTrials.gov