The aim of the study is to assess the effect of exogenous melatonin, 2 mg SR, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study.
Eligible participants will be contacted by the research team to provide informed consent for the study. Once the screening phase is completed, they will be ready to start the study consisting of: A) a \~2-week ambulatory phase at home with melatonin or placebo treatment; B) a 2-week wash-out period; C) same as A with the opposite treatment; Part A: The research project will start with a 16-day ambulatory data-collection period during which participants will receive either melatonin or a placebo. They will take 2 mg of exogenous melatonin in a slow release formulation (or placebo), 60 mins prior to bedtime for 15 days. Participants will be instructed to go to bed at a regular time and stay in darkness for 8 consecutive hours each night, trying to sleep. Part B: Throughout this period, all participants will stop taking their melatonin/placebo pills. After at least 2 weeks, they will prepare to participate to the other study condition. Parts C: Repetition of Ambulatory phase 1 (Part A) except that participants who received the active treatment will now receive placebo and vice versa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
Centre for Study and Treatment of Circadian Rhythms
Montreal, Quebec, Canada
Change in sleep duration
Sleep recorded with a portable device
Time frame: Change from baseline sleep duration at treatment day 15
Change in wake after sleep onset
Sleep recorded with a portable device
Time frame: Change from baseline sleep duration at treatment day 15
Change in sleep efficiency
Sleep recorded with a portable device
Time frame: Change from baseline sleep duration at treatment day 15
Urinary 6-sulfatoxy-melatonin levels
Urinary samples
Time frame: During sleep periods during the last 3 days of each treatment phase
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
A self-rated 19-item questionnaire, each of which has a range of 0 (no difficulty) to 3 (severe difficulty) points.These 19 items are combined to form 7 component scores reflecting different aspects of sleep quality. The 7 component scores are then added to yield one global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all area.
Time frame: Change between treatment conditions in PSQI score at treatment day 15
Nocturnal skin temperature
Skin measured around the nocturnal sleep periods
Time frame: Change between treatment conditions at bedtime at treatment days 14-15
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