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Completed

NCT Number: NCT03445962

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

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Apnea Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Intellectual Disability Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Polysomnography Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble Alpes

Échirolles, 38130, France

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment of OSAS predictive factors

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

Primary outcomes

  1. Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects

    Time frame: 4 months

    OSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).

Secondary outcomes

  1. dysautonomia role on OSAS in DS

    Time frame: 1 day

    Cardiac response during exercise (existence of chronotropic incompetence

    %HR(reserve)lower than 80%)

  2. Investigation of autonomic nervous system

    Time frame: 1 day

    spectral variations of blood pressure and heart rate variability during head-up tilt test : (spectral density in ms² and normalized units)

  3. Oxygenation and dysautonomia

    Time frame: 1 day

    Cerebral 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)

  4. Investigation of dysautonomia during sleep

    Time frame: 3 nignts

    spectral variations of heart rate variability (spectral density in ms² and normalized units)

  5. Biological profile

    Time frame: 1 day

    Disorders in blood parameters will be assessed by different inflammatory, corticotropic, thyroid and glycemic values in comparison with reference values.

  6. anthropometric characteristics role on OSAS in DS

    Time frame: 1 day

    Existence of morphologic specificities will be investigated:

    Craniofacial abnormalities with orthopantomogram (degree)

  7. Metabolic syndrome

    Time frame: 1 day

    Existence of morphologic specificities will be investigated:

    Neck, waist and hips circumferences (cm)

  8. morphologic parameters

    Time frame: 1 day

    Existence of morphologic specificities will be investigated:

    Body fat composition (%)

  9. Quantification of physical activity

    Time frame: 15 days

    Physical activity level will be assessed with actigraphy (min or h per day)

  10. Motor skills

    Time frame: 15 days

    motor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)

  11. questionnaire of physical activity

    Time frame: 15 days

    G- PAQ and parental perceptions of physical activity (score)

  12. Sleep questionnaire

    Time frame: 15 days

    Epworth and Pittsburg questionnaire (score)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: SYNAPSOT21

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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