An observational study in Down Syndrome, Sleep Apnea, Obstructive and Polysomnography, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by University Hospital, Grenoble · Observational
Among 40 studies in Down Syndrome with a site in France — 12 open to participants now, 12 under way, none of them phase 3. Down Syndrome · France.
Among the 40 studies in Down Syndrome with a site in France, this one is the 19th largest by enrollment of the 23 observational ones that give a count, is one of 2 that started in 2017, is one of 23 observational ones, and was the 20th registered.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
Browse Down Syndrome studies →12 of the 40 studies in Down Syndrome with a site in France are open now. Recruiting first, the newest first:
Hospices Civils de Lyon · Sites in France
Hospices Civils de Lyon · Sites in France
Aelis Farma · Sites in France, Italy, Spain
Hôpital le Vinatier · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2
First in 2000; this study’s year is marked. 2 started in 2017.
This study's enrollment of 40 is below the median of 158 across 145 observational studies indexed under Down Syndrome.
Median enrollment 150 across the 17 interventional studies, 100 across the 23 observational. Of the 24 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 40 have an industry lead sponsor. The 10 most frequent:
University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
University Hospital, Grenoble has 3 studies filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Down Syndrome with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06061562University Hospital, GrenobleDown Syndrome, Physical Activity and Sleep Apnea | 2026-12-31 |
| NCT05970965Assistance Publique - Hôpitaux de ParisPeriodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples | 2027-04-30 |
| NCT06866925Hôpital le VinatiertDCS for Catatonic Depression in Down Syndrome: A Pilot Study | 2027-08-01 |
Among the 40 studies in Down Syndrome with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The obstructive sleep apnea syndrome (OSAS) is frequently reported in subjects with trisomy 21. The consequences of this syndrome are expressed in various disorders such as cognitive and cardiovascular alterations. It is also reported a premature exhaustion with the achievement of various professional or recreational activities, as well as an increase in the frequency of daytime sleepiness. In trisomy 21, there are factors that are systematically associated with obstructive apnea. The identification of these factors would make it possible to diagnose OSAS earlier, under-diagnosed in the population with trisomy 21 even though these OSAS are associated with increased cardiovascular risks.
The aim of this study is to identify the predictive factors associated with sleep apnea in the trisomy population in order to propose early detection.
OSAS treatment in a young adult with Down syndrome could reduce physical fatigue apparition during various activities, reduce daytime sleepiness, and have a positive impact on physical fitness, and therefore more broadly on health.
The predictive factors for OSA that will be studied are: physical activity level, dentofacial disharmonies, blood parameters, motor disabilities, heart rate variability parameters measured during sleep and during autonomic nervous stimulation by orthostatic test.
All these factors will be linked to the data obtained by:
OSAS lead to many associated disorders, which identified early can be better supported to limit the deleterious effects of this OSAS:
(i) a sudden and repeated activation of the sympathetic nervous system triggered by sleep fragmentation (ii) intermittent hypoxia associated with OSAS may increase insulin resistance through the involvement of an inflammatory state and oxidative stress.
(iii) a significant level of diurnal fatigue limiting activities, thus promoting a sedentary lifestyle and increasing cardiovascular risk factors.
Several secondary objectives will therefore be studied:
Finally does the use seismocardiography make it possible to identify quickly and early these risk factors linked to OSAS?
Adults with Down syndome voluntary to participated
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects with Down syndrome, able to practice physical activity all participants have received information all have signed the consent form
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Assessment of OSAS predictive factors in Down Syndrome without or without OSAS
Diagnostic Test: Assessment of OSAS predictive factors
All subjects of the two groups realized the same assessment: * Anthropometric evaluation * biological examination (hormonal, inflammatory and complete blood count, and lipidic profile) * rest electrocardiogram * motor assessment (strenght, flexibility and balance) * actigraphy * Autonomic nervous system assessment during sleep * Autonomic nervous system assessment during head up tilt test before and after physical exercise * maximal treadmill test (VO2 max measure) * polysomnography * seismocardiography * questionnaires :sleep and physical activity
Identification of predictive factors associated to obstructive sleep apnea syndrome in DS subjects
OSAS will be diagnosed with polysomnography and seismocardiography. AHI threshold will be 15 to diagnose an OSAS (score).
Time frame: 4 months
dysautonomia role on OSAS in DS
Cardiac response during exercise (existence of chronotropic incompetence %HR(reserve)lower than 80%)
Time frame: 1 day
Investigation of autonomic nervous system
spectral variations of blood pressure and heart rate variability during head-up tilt test : (spectral density in ms² and normalized units)
Time frame: 1 day
Oxygenation and dysautonomia
Cerebral and peripheral oxygenation parameters measured with near-infrared spectroscopy during head-up tilt test (delta Hbtot between supine and head up tilt positions) \- Cardiac response during exercise (existence of chronotropic incompetence)
Time frame: 1 day
Investigation of dysautonomia during sleep
spectral variations of heart rate variability (spectral density in ms² and normalized units)
Time frame: 3 nignts
Biological profile
Disorders in blood parameters will be assessed by different inflammatory, corticotropic, thyroid and glycemic values in comparison with reference values.
Time frame: 1 day
anthropometric characteristics role on OSAS in DS
Existence of morphologic specificities will be investigated: Craniofacial abnormalities with orthopantomogram (degree)
Time frame: 1 day
Metabolic syndrome
Existence of morphologic specificities will be investigated: Neck, waist and hips circumferences (cm)
Time frame: 1 day
morphologic parameters
Existence of morphologic specificities will be investigated: Body fat composition (%)
Time frame: 1 day
Quantification of physical activity
Physical activity level will be assessed with actigraphy (min or h per day)
Time frame: 15 days
Motor skills
motor capacities : strength (explosive leg power (cm) and handgrip measure), flexibility (cm), balance (cm)
Time frame: 15 days
questionnaire of physical activity
G- PAQ and parental perceptions of physical activity (score)
Time frame: 15 days
Sleep questionnaire
Epworth and Pittsburg questionnaire (score)
Time frame: 15 days
Ran from Nov 2017 to primary completion in Jul 2019, 19 months.
Of 40 non-industry observational studies under Down Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 71. This study's 19 months is below that.
Counting every sponsor, half of 55 studies reached it within 34 months; a quarter within 19 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble →