Status:
NOT_YET_RECRUITING
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Obstructive Sleep Apnea
Down Syndrome (Trisomy 21)
Eligibility:
All Genders
5-6 years
Brief Summary
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In...
Eligibility Criteria
Inclusion
- (infants with Down Syndrome)
- Aged 6 months (±3 weeks)
- Diagnosed with Trisomy 21
- Affiliated to a social security scheme
- With informed consent of the 2 legal representatives
Exclusion
- Diagnosed with mosaic Down syndrome
- Born preterm (gestation age at birth \<37 weeks)
- Treated for OSA with Continuous Positive Airway Pressure
- Known allergy to silicone
- Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies
- Refusal from legal representatives.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07195253
Start Date
October 1 2025
End Date
October 1 2027
Last Update
September 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service d'épileptologie clinique, des troubles du sommeil et de neurologie fonctionnelle de l'enfant
Bron, France, 69500