NCT03445962

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

SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-07-11
• Completion: 2019-07-11
• First posted: 2018-02-26
• Last updated: 2025-12-29

Locations

1 site across 1 country: France