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Completed

NCT Number: NCT03090178

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

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.

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Key information

Conditions

Atopic Dermatitis Eczema

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-Louis

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Sleep quality

    Time frame: 15 days

    Measure of sleep quality

Secondary outcomes

  1. Sleep quantity

    Time frame: 15 days

    Measure of sleep quantity

Other outcomes

  1. Quality of life

    Time frame: two times a day for 15 days

    electronic patient report outcome on a secured mobile application

Sponsors and collaborators

Lead sponsor

Ad scientiam

Other

Registry information

Official study 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

Acronym: ACTISLEEP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2017
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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