Clinical trial NCT05440734: Exogenous Melatonin in Postmenopausal Women with Insomnia
Official title: Sleep and Circadian Rhythms in Men and Women - Protocol 4
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Keywords: menopause
aging
melatonin
circadian rhythms
sleep
alertness
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-07-01
Enrollment: 6
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover placebo-controlled study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Insomniac women will meet the diagnostic criteria for persistent insomnia as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). They will report subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months. Sleep disturbances will be coincident with the onset of the menopausal transition.
* Postmenopausal women will have amenorrhea for at least 12 months.
* Participants will be drug-free at the time of study, and will have a history of only moderate or no use of coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week), or other compounds.

Exclusion Criteria:

* Evidence of psychopathology on the Structured Clinical Interview for DSM-5, the Seasonal Pattern Assessment Questionnaire, the Beck Depression Inventory, and the Spielberger State Trait Anxiety Inventory.
* A history of prior gynecological pathology or medical condition that can affect the study results, including bilateral oophorectomy or endocrinopathy, and will not have used investigational drugs within 4 weeks of the study.
* A history of night work or transmeridian travel (across \>2 time zones) in the 2 months prior to the study.
* Evidence of sleep apnea (apnea/hypopnea index \> 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of PLMs \>15 per hour of sleep).

Primary outcomes:
measure: Change in sleep duration
timeFrame: Change from baseline sleep duration at treatment day 15
measure: Change in wake after sleep onset
timeFrame: Change from baseline sleep duration at treatment day 15
measure: Change in sleep efficiency
timeFrame: Change from baseline sleep duration at treatment day 15
measure: Urinary 6-sulfatoxy-melatonin levels
timeFrame: During sleep periods during the last 3 days of each treatment phase
Secondary outcomes:
measure: Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change between treatment conditions in PSQI score at treatment day 15
measure: Nocturnal skin temperature
timeFrame: Change between treatment conditions at bedtime at treatment days 14-15
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre for Study and Treatment of Circadian Rhythms
state: Quebec
Study officials:
affiliation: Douglas Hospital Research Centre
name: Diane B Boivin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: