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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445962
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date January 17, 2018
First Posted Date February 26, 2018
Last Update Posted Date October 8, 2019
Actual Study Start Date November 15, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 19, 2018)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 19, 2018)
  • dysautonomia role on OSAS in DS [ Time Frame: 1 day ]
    Cardiac response during exercise (existence of chronotropic incompetence %HR(reserve)lower than 80%)
  • 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)
  • 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)
  • Investigation of dysautonomia during sleep [ Time Frame: 3 nignts ]
    spectral variations of heart rate variability (spectral density in ms² and normalized units)
  • 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.
  • anthropometric characteristics role on OSAS in DS [ Time Frame: 1 day ]
    Existence of morphologic specificities will be investigated: Craniofacial abnormalities with orthopantomogram (degree)
  • Metabolic syndrome [ Time Frame: 1 day ]
    Existence of morphologic specificities will be investigated: Neck, waist and hips circumferences (cm)
  • morphologic parameters [ Time Frame: 1 day ]
    Existence of morphologic specificities will be investigated: Body fat composition (%)
  • Quantification of physical activity [ Time Frame: 15 days ]
    Physical activity level will be assessed with actigraphy (min or h per day)
  • Motor skills [ Time Frame: 15 days ]
    motor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)
  • questionnaire of physical activity [ Time Frame: 15 days ]
    G- PAQ and parental perceptions of physical activity (score)
  • Sleep questionnaire [ Time Frame: 15 days ]
    Epworth and Pittsburg questionnaire (score)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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?

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adults with Down syndome voluntary to participated
Condition
  • Down Syndrome
  • Sleep Apnea, Obstructive
  • Polysomnography
Intervention 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
Study Groups/Cohorts Down Syndrome (DS)
Assessment of OSAS predictive factors in Down Syndrome without or without OSAS
Intervention: Diagnostic Test: Assessment of OSAS predictive factors
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 19, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03445962
Other Study ID Numbers 38RC17.161
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Stéphane DOUTRELEAU, MD CHU Grenoble Alpes
PRS Account University Hospital, Grenoble
Verification Date April 2019