Back to resultsSleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy (ACTISLEEP)
Primary Purpose
Atopic Dermatitis Eczema
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electronic-Patient Report Outcome and wear of a wristband actigraph
Sponsored by
About this trial
This is an interventional other trial for Atopic Dermatitis Eczema
Eligibility Criteria
Inclusion Criteria:
Patients :
- Subjects using a smartphone running Apple operating system (iOS 7 and above) or Android (version 2.2 and above)
- Subjects agreeing to wear the actigraphy wristband at night
- Subjects 18 years old or older
- Subjects affiliated to French Health Insurance
- Subjects treated for moderate to severe atopic dermatitis or atopic dermatitis exacerbation* *The stage of the atopic dermatitis will be assessed by using the Eczema Area and Severity Index (EASI), Body Surface Area (BSA) and Investigator Global Assessment (IGA). The EASI is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis. The EASI was identified as one of the best-validated outcome measures for atopic dermatitis.
A moderate to severe atopic dermatitis corresponds to:
- Eczema Area and Severity Index score ≥ 7.1
- Investigator Global Assessment ≥ 3
- Body Surface Area ≥ 10
Healthy volunters :
- Subjects using a smartphone running iOS (iOS 7 and above) or Android (version 2.2 and above)
- Subjects agreeing to wear the actigraphy wristband at night
- Subjects 18 years old or older
- Subjects affiliated to French Health Insurance
- Subjects without a dermatology disease
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.
Sites / Locations
- Hôpital Saint-Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients
Healthy Volunteers
Arm Description
Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application: sleep diary Pruritus dermatology life quality index
Wear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application: sleep diary Pruritus dermatology life quality index
Outcomes
Primary Outcome Measures
Sleep quality
Measure of sleep quality
Secondary Outcome Measures
Sleep quantity
Measure of sleep quantity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03090178
Brief Title
Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy
Acronym
ACTISLEEP
Official Title
Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on Real-world Data Collection With a Smartphone Application and a Validated Actigraphy Wristband
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ad scientiam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
sleep diary
Pruritus
dermatology life quality index
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
Wear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
sleep diary
Pruritus
dermatology life quality index
Intervention Type
Other
Intervention Name(s)
electronic-Patient Report Outcome and wear of a wristband actigraph
Intervention Description
Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome
Primary Outcome Measure Information:
Title
Sleep quality
Description
Measure of sleep quality
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Sleep quantity
Description
Measure of sleep quantity
Time Frame
15 days
Other Pre-specified Outcome Measures:
Title
Quality of life
Description
electronic patient report outcome on a secured mobile application
Time Frame
two times a day for 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients :
Subjects using a smartphone running Apple operating system (iOS 7 and above) or Android (version 2.2 and above)
Subjects agreeing to wear the actigraphy wristband at night
Subjects 18 years old or older
Subjects affiliated to French Health Insurance
Subjects treated for moderate to severe atopic dermatitis or atopic dermatitis exacerbation* *The stage of the atopic dermatitis will be assessed by using the Eczema Area and Severity Index (EASI), Body Surface Area (BSA) and Investigator Global Assessment (IGA). The EASI is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis. The EASI was identified as one of the best-validated outcome measures for atopic dermatitis.
A moderate to severe atopic dermatitis corresponds to:
Eczema Area and Severity Index score ≥ 7.1
Investigator Global Assessment ≥ 3
Body Surface Area ≥ 10
Healthy volunters :
Subjects using a smartphone running iOS (iOS 7 and above) or Android (version 2.2 and above)
Subjects agreeing to wear the actigraphy wristband at night
Subjects 18 years old or older
Subjects affiliated to French Health Insurance
Subjects without a dermatology disease
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.
Facility Information:
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy
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