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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ad scientiam
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Patients
Wear a wristband actigraph while sleeping and answer to quality of questionnaires on a smartphone application:
- sleep diary
- Pruritus
- dermatology life quality index
干预措施: electronic-Patient Report Outcome and wear of a wristband actigraph (Other)
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
干预措施: electronic-Patient Report Outcome and wear of a wristband actigraph (Other)
结局指标
主要结局
Sleep quality
时间窗: 15 days
Measure of sleep quality
次要结局
- Sleep quantity(15 days)