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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Other: electronic-Patient Report Outcome and wear of a wristband actigraph

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital Saint-Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality	Measure of sleep quality	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quantity	Measure of sleep quantity	15 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	electronic patient report outcome on a secured mobile application	two times a day for 15 days

Collaborators and Investigators

• Sponsor: Ad scientiam

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2017
• Primary Completion (ACTUAL): June 15, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: P004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No