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

NCT03445962 | Completed

• 1 other identifier: 38RC17.161
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autonomic nervous system; Heart rate variability; Physical Activity; exercise; biological parameters; cephalometry; body composition; actigraphy; motor capacity; physical fitness; aerobic capacity; seismocardiography

Outcome Measures

Primary Outcomes (1)

• Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects

  OSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).

  4 months

Secondary Outcomes (12)

• dysautonomia role on OSAS in DS

  1 day

• Investigation of autonomic nervous system

  1 day

• Oxygenation and dysautonomia

  1 day

• Investigation of dysautonomia during sleep

  3 nignts

• Biological profile

  1 day

Study Arms (1)

Down Syndrome (DS)

Assessment of OSAS predictive factors in Down Syndrome without or without OSAS

Diagnostic Test: Assessment of OSAS predictive factors

Interventions

Assessment of OSAS predictive factors DIAGNOSTIC_TEST

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

Down Syndrome (DS)

Eligibility Criteria

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

Study Population

Adults with Down syndome voluntary to participated

You may qualify if:

• Subjects with Down syndrome, able to practice physical activity all participants have received information all have signed the consent form

You may not qualify if:

• pregnant women
• Pharmacological treatment altering autonomic nervous system (ANS)
• Contra-indication to physical exercise, such as atlanto-axial instability

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble Alpes

Échirolles, 38130, France

Location

Related Publications (4)

• Leti T, Guinot M, Favre-Juvin A, Bricout VA. Difference of catecholamine responses to exercise in men with trisomy 21, with or without chronotropic incompetence. Physiol Behav. 2015 Apr 1;142:97-103. doi: 10.1016/j.physbeh.2015.02.007. Epub 2015 Feb 4.

  PMID: 25660758 BACKGROUND

• Bricout VA, Guinot M, Faure P, Flore P, Eberhard Y, Garnier P, Juvin AF. Are hormonal responses to exercise in young men with Down's syndrome related to reduced endurance performance? J Neuroendocrinol. 2008 May;20(5):558-65. doi: 10.1111/j.1365-2826.2008.01695.x. Epub 2008 Mar 15.

  PMID: 18363810 BACKGROUND

• Flore P, Bricout VA, van Biesen D, Guinot M, Laporte F, Pepin JL, Eberhard Y, Favre-Juvin A, Wuyam B, van de Vliet P, Faure P. Oxidative stress and metabolism at rest and during exercise in persons with Down syndrome. Eur J Cardiovasc Prev Rehabil. 2008 Feb;15(1):35-42. doi: 10.1097/HJR.0b013e3282f2bff3.

  PMID: 18277183 BACKGROUND

• Nguyen TD, Baillieul S, Guinot M, Doutreleau S, Bricout VA. Classification of Factors Effect on Sleep in Individuals with Down Syndrome. Brain Sci. 2021 Nov 12;11(11):1500. doi: 10.3390/brainsci11111500.

  PMID: 34827499 RESULT

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Behavior

Study Officials

• Stéphane DOUTRELEAU, MD

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 26, 2018
• Study Start: November 15, 2017
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (1)