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

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ClinicalTrials.gov Identifier: NCT03445962
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment
Down Syndrome Sleep Apnea, Obstructive Polysomnography Diagnostic Test: Assessment of OSAS predictive factors

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?


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: SLEEP APNEA SYNDROME AND TRISOMY 21 : Exploration of the Predictive Factors in the Population With Trisomy 21
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Down Syndrome (DS)
Assessment of OSAS predictive factors in Down Syndrome without or without OSAS
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with Down syndome voluntary to participated
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445962


Contacts
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Contact: Véronique A BRICOUT, Phd +33 476 76 72 26 VBricout@chu-grenoble.fr
Contact: Tiphaine MONTAGNON +33 4 76 76 68 14 TMontagnon@chu-grenoble.fr

Locations
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France
CHU Grenoble Alpes Recruiting
Échirolles, France, 38130
Contact: Tiphaine Montagnon    +33 4 76 76 68 14    tmontagnon@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Stéphane DOUTRELEAU, MD CHU Grenoble Alpes

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03445962     History of Changes
Other Study ID Numbers: 38RC17.161
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
Autonomic nervous system
Heart rate variability
Physical Activity
exercise
biological parameters
cephalometry
body composition
actigraphy
motor capacity
physical fitness
aerobic capacity
seismocardiography

Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn