Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in AD patients. However, there has been no large randomized controlled trials. Hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with AD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
National Taiwan University Hospital
Taipei, Taiwan
Objective sleep measures as measured by actigraphs and SCORAD
actigraph parameters including sleep latency, sleep efficiency, total sleep time, and wake episodes and duration; SCORAD and objective SCORAD for disease severity assessment
Time frame: 4 weeks
urine and serum cytokines
serum levels of melatonin, urinary levels of 6-hydroxymelatonin sulfate, and serum levels of cytokines associated with sleep regulation including IL-10, IL-6, IL-4, IL-1b, and IL-31
Time frame: 4 weeks
total and allergen-specific IgE
total serum IgE and allergen specific IgE to Derp, Derf, SEA, and SEB
Time frame: 4 weeks
sleep parameters measured by polysomnography
sleep onset latency, sleep efficiency, wake episodes and duration, total sleep time, sleep stages, limb movement index
Time frame: 4 weeks
subjective improvement in symptoms
subjective assessment of whether sleep and dermatitis improved after treatment
Time frame: 4 weeks
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