Down Syndrome, Physical Activity and Sleep Apnea

Down Syndrome Clinical Trial

— TAPAS  

Official title:

Down Syndrome, Physical Activity and Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061562
• Other study ID #: 38RC23.0146
• Status: Recruiting
• Start date: January 11, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: Veronique BRICOUT
• Phone: 0476767226
• Email: VBricout[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Down Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnosis of Sleep Apnea Syndrome using calculation of apnea hypopnea index (AHI)>15 events/h	Visite 2: 2 nights
Secondary	Sleep-disordered breathing associated with dysautonomia	Polysomnography	Visite 2: 1 night
Secondary	Sleep-disordered breathing associated with dysautonomia	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	Visite 2: up to 3 nights
Secondary	Sleep-disordered breathing associated with dysautonomia	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	Visite 2: up to 3 nights
Secondary	Sleep-disordered breathing associated with specific abnormalities of the biological work-up	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.	Visite 1: the morning before the physical activity
Secondary	Sleep-disordered breathing associated with a specific cranial structure	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.	Day 0
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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).	Day 0 and visite 1
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	From inclusion to last visit of the patient: up to 90 days
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	Day 0 and visite 1: 1 time
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	Day 0 and visite 1: 1 time
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	Day 0 and visite 1: 1 time
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	Visite 1: up to 1 hour
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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)	Visite 1: up to 1 hour
Secondary	Sleep-disordered breathing associated with inadequate physical activity	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).	Visite 1: up to 1 hour
Secondary	Sleep-disordered breathing associated with inadequate physical activity	Effort response (% chronotropic response) will also be calculated to complete the autonomic profile.	Visite 1: up to 1 hour
Secondary	Sleep-disordered breathing associated with specific neurobehavioral disorders	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)	Day 0