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

NCT ID: NCT03445962

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2019-07-11

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.

Detailed Description

The predictive factors for OSA that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test.

All these factors will be linked to the data obtained by:

1. polysomnography

2. by the joint use of seismocardiography

OSAS lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this OSAS:

(i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with OSAS may increase insulin resistance through the involvement of an inflammatory state and oxidative stress.

(iii) a significant level of diurnal fatigue limiting activities, thus promoting a sedentary lifestyle and increasing cardiovascular risk factors.

Several secondary objectives will therefore be studied:

1. Can OSAS be predicted by the existence of autonomic dysfunction?

2. Can OSAS be predicted by specific biological disturbances?

3. Can OSAS be predicted by the presence of a specific cranial structure?

4. Can OSAS be predicted by an insufficient level of physical activity?

Finally does the use seismocardiography make it possible to identify quickly and early these risk factors linked to OSAS?

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Down Syndrome (DS)

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

Assessment of OSAS predictive factors

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphane DOUTRELEAU, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

CHU Grenoble Alpes

Échirolles, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 25660758 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18363810 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18277183 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34827499 (View on PubMed)

Other Identifiers

38RC17.161

Identifier Type: -

Identifier Source: org_study_id