Down SyndromeTAPASNCT06061562
Down Syndrome, Physical Activity and Sleep Apnea
An observational study of Down Syndrome, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Down Syndrome
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2024to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
La Tronche, 38043
Véronique BRICOUT, PHD, VBRICOUT@chu-grenoble.fr
About this study
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.
Read the 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.
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, sleep disorders, Apnea, physical activity, neurocognition, autonomic nervous system
- Medical subject headings
- Down Syndrome, Sleep Wake Disorders, Apnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DS group | A cohort of participants (child, teenager, or adult), with or without sleep disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visite 2: 2 nights
Secondary outcomes (15)
Sleep-disordered breathing associated with dysautonomia
Polysomnography
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start11 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien BAILLIEUL, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061562
- Sponsor's protocol ID
- 38RC23.0146
- Acronym
- TAPAS
- Status last verified
- Jan 2024
- First submitted
- 15 Jun 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Down Syndrome, Physical Activity and Sleep Apnea
- ClinicalTrials.gov ID
- NCT06061562
- Acronym / sponsor ID
- TAPAS / 38RC23.0146
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, sleep disorders, Apnea, physical activity, neurocognition, autonomic nervous system
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS group | – | –A cohort of participants (child, teenager, or adult), with or without sleep disorders |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Total autosomal trisomy caused by the presence of a third copy (partial or total) of chromosome 21
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
15 secondary outcomes
Sleep-disordered breathing associated with dysautonomia
Time frame: Visite 2: 1 night
Sleep-disordered breathing associated with dysautonomia
Time frame: Visite 2: up to 3 nights
Sleep-disordered breathing associated with dysautonomia
Time frame: Visite 2: up to 3 nights
Sleep-disordered breathing associated with specific abnormalities of the biological work-up
Time frame: Visite 1: the morning before the physical activity
Sleep-disordered breathing associated with a specific cranial structure
Time frame: Day 0
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Day 0 and visite 1
Sleep-disordered breathing associated with inadequate physical activity
Time frame: From inclusion to last visit of the patient: up to 90 days
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Day 0 and visite 1: 1 time
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Day 0 and visite 1: 1 time
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Day 0 and visite 1: 1 time
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Visite 1: up to 1 hour
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Visite 1: up to 1 hour
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Visite 1: up to 1 hour
Sleep-disordered breathing associated with inadequate physical activity
Time frame: Visite 1: up to 1 hour
Sleep-disordered breathing associated with specific neurobehavioral disorders
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sébastien BAILLIEUL principal investigator
University Grenoble Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronique BRICOUT (0476767226, VBricout@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Visite 2: 2 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.