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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03445962
Acronym
SYNAPSOT21
Enrollment
40
Registered
2018-02-26
Start date
2017-11-15
Completion date
2019-07-11
Last updated
2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Polysomnography, Sleep Apnea, Obstructive

Keywords

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

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?

Interventions

DIAGNOSTIC_TESTAssessment 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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects4 monthsOSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).

Secondary

MeasureTime frameDescription
Investigation of autonomic nervous system1 dayspectral variations of blood pressure and heart rate variability during head-up tilt test : (spectral density in ms² and normalized units)
Oxygenation and dysautonomia1 dayCerebral and peripheral oxygenation parameters measured with near-infrared spectroscopy during head-up tilt test (delta Hbtot between supine and head up tilt positions) \- Cardiac response during exercise (existence of chronotropic incompetence)
Investigation of dysautonomia during sleep3 nigntsspectral variations of heart rate variability (spectral density in ms² and normalized units)
Biological profile1 dayDisorders in blood parameters will be assessed by different inflammatory, corticotropic, thyroid and glycemic values in comparison with reference values.
anthropometric characteristics role on OSAS in DS1 dayExistence of morphologic specificities will be investigated: Craniofacial abnormalities with orthopantomogram (degree)
dysautonomia role on OSAS in DS1 dayCardiac response during exercise (existence of chronotropic incompetence %HR(reserve)lower than 80%)
morphologic parameters1 dayExistence of morphologic specificities will be investigated: Body fat composition (%)
Quantification of physical activity15 daysPhysical activity level will be assessed with actigraphy (min or h per day)
Motor skills15 daysmotor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)
questionnaire of physical activity15 daysG- PAQ and parental perceptions of physical activity (score)
Sleep questionnaire15 daysEpworth and Pittsburg questionnaire (score)
Metabolic syndrome1 dayExistence of morphologic specificities will be investigated: Neck, waist and hips circumferences (cm)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026