ACTISLEEP Study: Sleep disorders in patients with atopic dermatitis
Introduction & objective : Atopic dermatitis (AD) is a chronic inflammatory disease of the skin with a significant impact on the quality of life particularly related to sleep disorders secondary to pruritus. This study aims to evaluate the sleep of patients with AD and compare it to that of healthy volunteers (HV) using wrist actigraphy and a smartphone application (Actisleep) developed by Ad Scientiam, Brain and Spine Institute (ICM), Pitié-Salpêtrière Hospital (Paris, France).
Design : 32 patients with moderate to severe AD (EASI score ≥ 7.1, IGA ≥ 3 and BSA ≥ 10) and 20 HV were included.
Sleep data were recorded during 14 days (Actisleep smartphone application, morning and evening) and 14 nights (non-dominant wrist actigraphy, Motionwatch8, CamNtech, Cambridge, United Kingdom)
Parameters analysed were Total Sleep Time (TST), Sleep Efficiency (SE), Time In Bed (TIB), Wake-up After Sleep Onset (WASO), number and duration of awakenings, and the Fragmentation Index (FI). The severity of the disease was assessed at the beginning of the study. Quality of Life (DLQI) was also assessed once a week.
Population : Statistical analysis was conducted using linear mixed model (LMM) to take into account the repetition of the measurements in the same subject.
To compare quality and quantity of sleep, participants should have Actisleep morning records and actigraph data for at least 4 consecutive days in the week, without considering weekend.
For correlations analysis, participants should have at least 6 days in common between e-questionnaire and actigraphy. Among the 52 participants enrolled in the study, 15 patients and 18 HV fulfil statistical criteria for comparisons between groups (426 morning questionnaires and 435 actigraph data) and 15 patients and 19 HV for correlation analysis between actigraphy and Actisleep application (410 morning questionnaires and actigraph data). Patients and volunteers mean age was similar: 33 years ± 11 vs 31 years ± 10 (p=0.61). The ratio of women to men was 2.75 in patients and 2 in HV (p=0.72). The 2 populations were comparable for age and sex criteria.
Results : 83% of patients and HV had analyzable data from the application (75% for the actigraphy). Actigraphy revealed that the TST, the WASO, the SE and the FI were significantly different between patients and HV. The Actisleep application revealed that the Number of awakenings, the WASO and the SE were significantly different between patients and HV. In both cases the TIB was not significantly different between patients and HV. Bedtime, falling asleep time, wake-up time and get up time were strongly correlated between the Actigraphy and the Actisleep application. Unsurprisingly, the DLQI questionnaire reported an alteration of the quality of life in patients (100%) versus HV (5%).