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

NCT03090178 | Completed

• 1 other identifier: P004
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Measure of sleep quality

  15 days

Secondary Outcomes (1)

• Sleep quantity

  15 days

Other Outcomes (1)

• Quality of life

  two times a day for 15 days

Study Arms (2)

Patients

EXPERIMENTAL

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

Healthy Volunteers

ACTIVE COMPARATOR

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

Interventions

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

Healthy Volunteers; Patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If a participant is taking hypnotic treatments during his study participation, he will be excluded from the clinical trial.

Sponsors & Collaborators

• Ad scientiam: lead

Study Sites (1)

Hôpital Saint-Louis

Paris, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: June 2, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

FR (1)