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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Polysomnography
Down Syndrome
Sleep Apnea, Obstructive

Treatments

Diagnostic Test: Assessment of OSAS predictive factors

Study type

Observational

Funder types

Other

Identifiers

NCT03445962
38RC17.161

Details and patient eligibility

About

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.

Full 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: polysomnography 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: Can OSAS be predicted by the existence of autonomic dysfunction? Can OSAS be predicted by specific biological disturbances? Can OSAS be predicted by the presence of a specific cranial structure? 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?

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Down Syndrome (DS)
Description:
Assessment of OSAS predictive factors in Down Syndrome without or without OSAS
Treatment:
Diagnostic Test: Assessment of OSAS predictive factors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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