Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia
NCT ID: NCT05378932
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2022-06-10
2024-01-16
Brief Summary
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Sleep efficiency, assessed on actigraphy, sleep architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the patients with hypohidrotic ectodermal dysplasia with healthy controls.
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Detailed Description
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Core body temperature is one of the players of the internal biological clock that regulates sleep. Indeed, sleep is induced by a decrease in core body temperature concomitant with a peak of melatonin secretion. Consequently, the absence of sweating in HED and therefore the inability to lower core body temperature may explain the poor sleep quality reported by patients. However, sleep disturbances have not been analyzed in the literature nor the relationship between sleep quality and core body temperature in patients with HED.
The sleep of patients with HED who are followed at the national reference center for rare diseases of the skin and mucous membranes of genetic origin (MAGEC center) of the Necker-Enfants Malades hospital will be evaluated and compared to sleep of healthy controls screened within in the patient's family.
The main objective of the study is to compare the sleep efficiency evaluated on actigraphy between HED patients and healthy controls.
Sleep efficiency will be measured by means of actigraphy during 10 days and one overnight polysomnography, together with continuous recording of proximal and distal skin temperature during 10 days, one-off measurement of sweating by a sweat test and urine melatonin assay over 24 hours.
Subjective sleep quality will also be assessed by means of questionnaires in patients and healthy controls. Finally, patients with HED will also have a standardized psychological and neuropsychological assessment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Hypohidrotic ectodermal dysplasia
Patients aged 3 to 40 years old with hypohidrotic ectodermal dysplasia.
Actigraphy
Sleep efficiency recording at home by means of actigraphy during 10 consecutive days.
Recording of proximal and distal skin temperature and temperature of the bedroom
Recording of proximal and distal skin temperature at home by data loggers placed on the skin during 10 consecutive days.
Recording of temperature of the bedroom by a data logger during 10 consecutive days.
Questionnaires assessing subjective sleep quality
One-off questionnaires assessing subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality with questions about sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction during the last month.
The Epworth Sleepiness Scale evaluates daytime sleepiness and comprises 8 items (situations) during which individuals assess how likely they would fall asleep.
Sweat test
One-off measurement of sweating by a sweat test at the hospital.
Urine melatonin assay
Two urine melatonin at home during 24 hours, one during a week day and one during the weekend
Polysomnography
Sleep architecture assessed by a polysomnography during one night at home.
Standardized psychological and neuropsychological assessment
One-off psychological and neuropsychological assessment of patients with HED during a hospital visit
Healthy controls
Healthy controls aged 3 to 40 years old without hypohidrotic ectodermal dysplasia.
Actigraphy
Sleep efficiency recording at home by means of actigraphy during 10 consecutive days.
Recording of proximal and distal skin temperature and temperature of the bedroom
Recording of proximal and distal skin temperature at home by data loggers placed on the skin during 10 consecutive days.
Recording of temperature of the bedroom by a data logger during 10 consecutive days.
Questionnaires assessing subjective sleep quality
One-off questionnaires assessing subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality with questions about sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction during the last month.
The Epworth Sleepiness Scale evaluates daytime sleepiness and comprises 8 items (situations) during which individuals assess how likely they would fall asleep.
Sweat test
One-off measurement of sweating by a sweat test at the hospital.
Urine melatonin assay
Two urine melatonin at home during 24 hours, one during a week day and one during the weekend
Polysomnography
Sleep architecture assessed by a polysomnography during one night at home.
Interventions
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Actigraphy
Sleep efficiency recording at home by means of actigraphy during 10 consecutive days.
Recording of proximal and distal skin temperature and temperature of the bedroom
Recording of proximal and distal skin temperature at home by data loggers placed on the skin during 10 consecutive days.
Recording of temperature of the bedroom by a data logger during 10 consecutive days.
Questionnaires assessing subjective sleep quality
One-off questionnaires assessing subjective sleep quality. The Pittsburgh Sleep Quality Index (PSQI) evaluates sleep quality with questions about sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction during the last month.
The Epworth Sleepiness Scale evaluates daytime sleepiness and comprises 8 items (situations) during which individuals assess how likely they would fall asleep.
Sweat test
One-off measurement of sweating by a sweat test at the hospital.
Urine melatonin assay
Two urine melatonin at home during 24 hours, one during a week day and one during the weekend
Polysomnography
Sleep architecture assessed by a polysomnography during one night at home.
Standardized psychological and neuropsychological assessment
One-off psychological and neuropsychological assessment of patients with HED during a hospital visit
Eligibility Criteria
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Inclusion Criteria
* Healthy controls (control subjects), of same age group, recruited if possible within the patient's direct entourage
* Written informed consent
Exclusion Criteria
* 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
3 Years
40 Years
MALE
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Lucie Griffon, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Brigitte Fauroux, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Smail Hadj-Rabia, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker-Enfants Malades
Paris, , France
Countries
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Other Identifiers
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2021-A02736-35
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220045
Identifier Type: -
Identifier Source: org_study_id
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