Exogenous Melatonin in Postmenopausal Women With Insomnia

Insomnia Clinical Trial

Official title:

Sleep and Circadian Rhythms in Men and Women - Protocol 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440734
• Other study ID #: 2018-175
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Douglas Mental Health University Institute
• Contact: Diane B Boivin, MD, PhD
• Phone: 514-761-6131
• Email: diane.boivin[@]douglas.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Melatonin
2 Mg Oral Tablet, slow release
• Placebo
placebo pill identical to the treatment pill

Locations

Country	Name	City	State
Canada	Centre for Study and Treatment of Circadian Rhythms	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep duration	Sleep recorded with a portable device	Change from baseline sleep duration at treatment day 15
Primary	Change in wake after sleep onset	Sleep recorded with a portable device	Change from baseline sleep duration at treatment day 15
Primary	Change in sleep efficiency	Sleep recorded with a portable device	Change from baseline sleep duration at treatment day 15
Primary	Urinary 6-sulfatoxy-melatonin levels	Urinary samples	During sleep periods during the last 3 days of each treatment phase
Secondary	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.	Change between treatment conditions in PSQI score at treatment day 15
Secondary	Nocturnal skin temperature	Skin measured around the nocturnal sleep periods	Change between treatment conditions at bedtime at treatment days 14-15