Clinical trial NCT06061562: Down Syndrome, Physical Activity and Sleep Apnea
Official title: Down Syndrome, Physical Activity and Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Down Syndrome
Keywords: Down syndrome
sleep disorders
Apnea
physical activity
neurocognition
autonomic nervous system
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Down syndrome is associated with numerous clinical expressions. The most frequent are deficits in cognitive development, autonomic nervous system dysfunctions, cardiovascular dysfunctions, and osteoarticular specificities. Taken together, these clinical features can lead to a sedentary and overweight lifestyle, directly responsible for the onset of early fatigue and effort limitation. Numerous co-morbidities are also reported, such as the presence of sleep apnea syndrome.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Visite 2: 2 nights
Secondary outcomes:
measure: Sleep-disordered breathing associated with dysautonomia
timeFrame: Visite 2: 1 night
measure: Sleep-disordered breathing associated with dysautonomia
timeFrame: Visite 2: up to 3 nights
measure: Sleep-disordered breathing associated with dysautonomia
timeFrame: Visite 2: up to 3 nights
measure: Sleep-disordered breathing associated with specific abnormalities of the biological work-up
timeFrame: Visite 1: the morning before the physical activity
measure: Sleep-disordered breathing associated with a specific cranial structure
timeFrame: Day 0
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Day 0 and visite 1
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: From inclusion to last visit of the patient: up to 90 days
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Day 0 and visite 1: 1 time
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Day 0 and visite 1: 1 time
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Day 0 and visite 1: 1 time
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Visite 1: up to 1 hour
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Visite 1: up to 1 hour
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Visite 1: up to 1 hour
measure: Sleep-disordered breathing associated with inadequate physical activity
timeFrame: Visite 1: up to 1 hour
measure: Sleep-disordered breathing associated with specific neurobehavioral disorders
timeFrame: Day 0
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Grenoble Hospital
name: Sébastien BAILLIEUL
role: PRINCIPAL_INVESTIGATOR
References: