An observational study in Down Syndrome, sponsored by University Hospital, Grenoble. Recruiting at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by University Hospital, Grenoble · Observational
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.
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 141 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
A cohort of participants (child, teenager, or adult), with or without sleep disorders
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
Time frame: Visite 2: 2 nights
Sleep-disordered breathing associated with dysautonomia
Polysomnography
Time frame: Visite 2: 1 night
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
Time frame: Visite 2: up to 3 nights
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
Time frame: Visite 2: up to 3 nights
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.
Time frame: Visite 1: the morning before the physical activity
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.
Time frame: Day 0
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).
Time frame: Day 0 and visite 1
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)
Time frame: From inclusion to last visit of the patient: up to 90 days
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)
Time frame: Day 0 and visite 1: 1 time
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)
Time frame: Day 0 and visite 1: 1 time
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)
Time frame: Day 0 and visite 1: 1 time
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)
Time frame: Visite 1: up to 1 hour
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)
Time frame: Visite 1: up to 1 hour
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).
Time frame: Visite 1: up to 1 hour
Sleep-disordered breathing associated with inadequate physical activity
Effort response (% chronotropic response) will also be calculated to complete the autonomic profile.
Time frame: Visite 1: up to 1 hour
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)
Time frame: Day 0
Plan to share: Undecided
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University Hospital, Grenoble