Down Syndrome, Physical Activity and Sleep Apnea

Recruiting

• Conditions: Down Syndrome

• Registration Number: NCT06061562
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-29
• Status Verified: 2024-01
• Study Start: 2024-01-11
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Visite 2: 2 nights	Diagnosis of Sleep Apnea Syndrome using calculation of apnea hypopnea index (AHI)\>15 events/h

Secondary Outcome Measures

Name	Time	Method
Sleep-disordered breathing associated with dysautonomia	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
Sleep-disordered breathing associated with a specific cranial structure	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.
Sleep-disordered breathing associated with inadequate physical activity	Visite 1: up to 1 hour	Effort response (% chronotropic response) will also be calculated to complete the autonomic profile.
Sleep-disordered breathing associated with specific abnormalities of the biological work-up	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.
Sleep-disordered breathing associated with specific neurobehavioral disorders	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)

Trial Locations

Locations (1)

Chu Grenoble Alpes; 🇫🇷 La Tronche, France