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NCT Number: NCT06061562

Down Syndrome, Physical Activity and Sleep Apnea

To realize a sleep phenotyping in a population with Down syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Apnea Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Wake Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

La Tronche, 38043, France

Location status: Recruiting

Location contact

Véronique BRICOUT, PHD

CONTACT

[email protected]

About this study

Sleep disorders are widely observed in the Down's syndrome population, due to a number of risk factors, and can become established in early childhood. Diagnosis of sleep disorders in Down's syndrome is difficult and often delayed, which can contribute to poor health in children with Down's syndrome. Phenotyping sleep characteristics in this Down Syndrome population will enable early identification of the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21

Exclusion criteria

  • People with abnormal electrocardiographic tracings,
  • Existence of heart failure or cardiovascular disease, as determined by any abnormalities in cardiovascular adaptations to exercise.
  • Existence of a declared or uncontrolled progressive disease.
  • pregnant or breast-feeding women.

Treatment and study plan

Primary outcomes

  1. phenotyping of sleep in a population with Down's syndrome, its determinants, and the consequences of these disorders, with a specific focus on sleep apnea syndrome, whose origin is multisystemic

    Time frame: Visite 2: 2 nights

    Diagnosis of Sleep Apnea Syndrome using calculation of apnea hypopnea index (AHI)>15 events/h

Secondary outcomes

  1. Sleep-disordered breathing associated with dysautonomia

    Time frame: Visite 2: 1 night

    Polysomnography

  2. Sleep-disordered breathing associated with dysautonomia

    Time frame: Visite 2: up to 3 nights

    Heart rate (beat per min) recording using a cardiofrequency meter to measure the RR interval (in milliseconds); measured over 3 nights max in an ecological environment

  3. Sleep-disordered breathing associated with dysautonomia

    Time frame: Visite 2: up to 3 nights

    The variables used to assess the autonomic profile will be obtained by calculating LF and LF(low and high frequency in ms² and normalized units) spectral variations and the LF/HF ratio

  4. Sleep-disordered breathing associated with specific abnormalities of the biological work-up

    Time frame: Visite 1: the morning before the physical activity

    Biological disturbances will be assessed by differences in thyroid function, and other biological variables (NFS, lipid and hormone levels, iron levels) in comparison with standards. This biological assessment is obtained by blood sampling.

  5. Sleep-disordered breathing associated with a specific cranial structure

    Time frame: Day 0

    The existence of cranial anatomical variations, in particular anomalies specific to the oral sphere (modification of the gonia angle (in degrees), and prognatism (in cm)) will be investigated by cephalometry.

  6. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Day 0 and visite 1

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by questionnaires (scores).

  7. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: From inclusion to last visit of the patient: up to 90 days

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by actimetry (min per day)

  8. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Day 0 and visite 1: 1 time

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by anthropometric variables (Weight (kg)

  9. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Day 0 and visite 1: 1 time

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by Height (m)

  10. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Day 0 and visite 1: 1 time

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by BMI (kg/m²)

  11. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Visite 1: up to 1 hour

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by determinants of physical fitness (measurement of strength (Newton)

  12. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Visite 1: up to 1 hour

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by flexibility (cm)

  13. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Visite 1: up to 1 hour

    Abnormalities in the physiological response to exercise (VO2 (in mL/kg/min) compared with the predicted value) will be investigated and linked to the level of physical activity measured by balance variables (seconds).

  14. Sleep-disordered breathing associated with inadequate physical activity

    Time frame: Visite 1: up to 1 hour

    Effort response (% chronotropic response) will also be calculated to complete the autonomic profile.

  15. Sleep-disordered breathing associated with specific neurobehavioral disorders

    Time frame: Day 0

    A neurobehavioral profile assessment will be carried out using several tests, in order to verify the possible impact of TdS on cognitive function:

    • Intelligence quotient (Wechsler scale), if not previously performed (score)
    • Stroop task (inhibitory control) (score)
    • Reaction time using a light device (seconds)
    • Ability to perform a double cognitive-motor task, (score)
    • BRIEF questionnaire (to explore executive function) (score)
    • ADHD rating scale (to explore signs of attention deficit/hyperactivity disorder). (score)

Study contacts

Contact information is provided by the study sponsor or research team.

Veronique BRICOUT

CONTACT

[email protected]

0476767226

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: TAPAS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2023
Registry last updated
Jan 17, 2024

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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