Status:
COMPLETED
Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Hypohidrotic Ectodermal Dysplasia
Eligibility:
MALE
3-40 years
Phase:
NA
Brief Summary
The aim of the study is to compare sleep efficiency by means of actigraphy in patients with hypohidrotic ectodermal dysplasia with healthy controls. Sleep efficiency, assessed on actigraphy, sleep ar...
Detailed Description
Ectodermal dysplasias (ED) are rare genetic diseases characterized by a developmental abnormality of at least two of the following ectodermal derivatives: teeth, nails, pilosity and glands. In the hyp...
Eligibility Criteria
Inclusion
- Male patients with molecularly confirmed hypohidrotic ectodermal dysplasia (HED), children over 3 years of age and adults under 40 years of age. Patients will be separated into 3 age groups (3 to 6 years old, 7 to 12 years old, 13 years old and over)
- Healthy controls (control subjects), of same age group, recruited if possible within the patient's direct entourage
- Written informed consent
Exclusion
- No social insurance
- Presence of an associated pathology known to alter the quality of sleep (neurological, cardiac, psychiatric, severe sleep apnea syndrome)
- Presence of an associated pathology causing significant psychomotor retardation, behavioral disorders with impossible cooperation or significant agitation
- Treatment with psychotropic drugs or drugs stimulating vigilance
- Patient under guardianship/curatorship
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05378932
Start Date
June 10 2022
End Date
January 16 2024
Last Update
September 12 2025
Active Locations (1)
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1
Hôpital Necker-Enfants Malades
Paris, France, 75015