Clinical trial NCT03445962: 19/5000 (SYNAPSOT21) Predictive Factors of Sleep Apnea Syndrome in Down Syndrome
Official title: SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with Down syndome voluntary to participated

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?

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

Primary outcomes:
measure: Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects
timeFrame: 4 months
Secondary outcomes:
measure: dysautonomia role on OSAS in DS
timeFrame: 1 day
measure: Investigation of autonomic nervous system
timeFrame: 1 day
measure: Oxygenation and dysautonomia
timeFrame: 1 day
measure: Investigation of dysautonomia during sleep
timeFrame: 3 nignts
measure: Biological profile
timeFrame: 1 day
measure: anthropometric characteristics role on OSAS in DS
timeFrame: 1 day
measure: Metabolic syndrome
timeFrame: 1 day
measure: morphologic parameters
timeFrame: 1 day
measure: Quantification of physical activity
timeFrame: 15 days
measure: Motor skills
timeFrame: 15 days
measure: questionnaire of physical activity
timeFrame: 15 days
measure: Sleep questionnaire
timeFrame: 15 days
Other outcomes:
Locations:
city: Échirolles
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Stéphane DOUTRELEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.