Down Syndrome, Physical Activity and Sleep Apnea
NCT06061562, Recruiting, University Hospital, Grenoble
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Down Syndrome, Physical Activity and Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT06061562 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Grenoble | ClinicalTrials.gov |
| Conditions | Down Syndrome | ClinicalTrials.gov |
| First posted | 2023-09-29 | ClinicalTrials.gov |
| Last updated | 2024-01-17 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| 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 | Visite 2: 2 nights | Diagnosis of Sleep Apnea Syndrome using calculation of apnea hypopnea index (AHI)\>15 events/h | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with dysautonomia | Visite 2: 1 night | Polysomnography | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with dysautonomia | Visite 2: up to 3 nights | 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 | ClinicalTrials.gov |
| Secondary | 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 | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Day 0 and visite 1 | 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). | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | From inclusion to last visit of the patient: up to 90 days | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Day 0 and visite 1: 1 time | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Day 0 and visite 1: 1 time | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Day 0 and visite 1: 1 time | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Visite 1: up to 1 hour | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Visite 1: up to 1 hour | 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) | ClinicalTrials.gov |
| Secondary | Sleep-disordered breathing associated with inadequate physical activity | Visite 1: up to 1 hour | 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). | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)