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Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on E-diary on a Smartphone Application and Actigraphy (ACTISLEEP)

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ClinicalTrials.gov Identifier: NCT03090178
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ad scientiam

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Other: electronic-Patient Report Outcome and wear of a wristband actigraph Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Other
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
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : June 15, 2018
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients

Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:

  • sleep diary
  • Pruritus
  • dermatology life quality index
 Other: electronic-Patient Report Outcome and wear of a wristband actigraph
Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome
Active Comparator: Healthy Volunteers

Wear of a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:

  • sleep diary
  • Pruritus
  • dermatology life quality index
 Other: electronic-Patient Report Outcome and wear of a wristband actigraph
Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome


Outcome Measures
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Primary Outcome Measures :
  1. Sleep quality [ Time Frame: 15 days ]
    Measure of sleep quality


Secondary Outcome Measures :
  1. Sleep quantity [ Time Frame: 15 days ]
    Measure of sleep quantity


Other Outcome Measures:
  1. Quality of life [ Time Frame: two times a day for 15 days ]
    electronic patient report outcome on a secured mobile application


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090178


Locations
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France
Hôpital Saint-Louis
Paris, France
Sponsors and Collaborators
Ad scientiam
More Information
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Responsible Party: Ad scientiam
ClinicalTrials.gov Identifier: NCT03090178     History of Changes
Other Study ID Numbers: P004
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases