Impact of Dysregulation of Core Body Temperature on Sleep in Patients With Hypohidrotic Ectodermal Dysplasia

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 architecture assessed on on polysomnography, body temperature and urine melatonin levels will be compared between the patients with hypohidrotic ectodermal dysplasia with healthy controls.

Conditions

• Hypohidrotic Ectodermal Dysplasia

Interventions

OTHER

Actigraphy

Sleep efficiency recording at home by means of actigraphy during 10 consecutive days.

OTHER

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.

OTHER

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.

OTHER

Sweat test

One-off measurement of sweating by a sweat test at the hospital.

OTHER

Urine melatonin assay

Two urine melatonin at home during 24 hours, one during a week day and one during the weekend

OTHER

Polysomnography

Sleep architecture assessed by a polysomnography during one night at home.

OTHER

Standardized psychological and neuropsychological assessment

One-off psychological and neuropsychological assessment of patients with HED during a hospital visit

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Lucie Griffon, MD · Assistance Publique - Hôpitaux de Paris

• Brigitte Fauroux, MD, PhD · Assistance Publique - Hôpitaux de Paris

• Smail Hadj-Rabia, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-10

Primary Completion

2024-01-16

Completion

2024-01-16

Countries

• France

Study Locations