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Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Quality of Life (QoL) can also be evaluated retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data retrospectively introduces a significant recall bias that can be addressed by collecting data in Real World (RW). Real World data collection is prospective and take place within the patient's own environment. While data collection is generally done with diaries, it has been demonstrated that smartphone and connected devices were able to produce more precise and granular data than traditional methods.
The main objective of the study is to demonstrate a medical hypothesis using a wristband actigraph: patients with moderate to severe atopic dermatitis have a poorer quality and quantity of sleep than healthy subject.
Secondary objetives are to assess the interest of a smartphone application in evaluating the quality of life of patients with moderate to severe atopic dermatitis in regard of those of healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
|
|
| Healthy Volunteers | Active Comparator | Wear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electronic-Patient Report Outcome and wear of a wristband actigraph | Other | Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | Measure of sleep quality | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quantity | Measure of sleep quantity | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | electronic patient report outcome on a secured mobile application | two times a day for 15 days |
Inclusion Criteria:
Patients :
A moderate to severe atopic dermatitis corresponds to:
Healthy volunters :
Non inclusion Criteria:
-Illiterate subjects
Subjects not proficient in French
Subject with a primary insomnia*
*Insomnia, sleep apnea and hypersomnia will be evaluated with respectively 3 tests:
Insomnia Severity Index (ISI);
Berlin Sleep Apnea Scale;
Epworth Scale
Subjects treated by hypnotic drugs
Pregnant woman
Subjects under guardianship
Exclusion criteria:
If a participant is taking hypnotic treatments during his study participation, he will be excluded from the clinical trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint-Louis | Paris | France |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 7, 2021 | |
| Reset | Jan 27, 2021 | |
| Release | Jun 24, 2021 |
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Investigators will first enroll patients, then healthy volunters. Healthy volunters will be matched to patients on age, sexe and wake up at a programmed time
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| Reset | Jul 13, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 7, 2021 | Jan 27, 2021 | |||
| Jun 24, 2021 | Jul 13, 2021 |