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Exogenous Melatonin in Postmenopausal Women With Insomnia

Primary Purpose

Insomnia

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Melatonin

Placebo

About this trial

This is an interventional treatment trial for Insomnia focused on measuring menopause, aging, melatonin, circadian rhythms, sleep, alertness

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Centre for Study and Treatment of Circadian RhythmsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days

2 mg oral tablet, 1x 60 min before bedtime for 15 days

Outcomes

Primary Outcome Measures

Change in sleep duration

Sleep recorded with a portable device

Change in wake after sleep onset

Sleep recorded with a portable device

Change in sleep efficiency

Sleep recorded with a portable device

Urinary 6-sulfatoxy-melatonin levels

Urinary samples

Secondary Outcome Measures

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.

Nocturnal skin temperature

Skin measured around the nocturnal sleep periods

Full Information

NCT ID

NCT05440734

First Posted

June 17, 2022

Last Updated

October 25, 2022

Sponsor

Douglas Mental Health University Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT05440734

Brief Title

Exogenous Melatonin in Postmenopausal Women With Insomnia

Official Title

Sleep and Circadian Rhythms in Men and Women - Protocol 4

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 17, 2022 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Douglas Mental Health University Institute

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

menopause, aging, melatonin, circadian rhythms, sleep, alertness

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized crossover placebo-controlled study

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

The nature of the treatment (melatonin vs placebo) will only be unrevealed when the key parameters have been determined (e.g, PSG sleep scoring, alertness levels, vasomotor symptoms, adverse effects, hormone levels).

Allocation

Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Melatonin

Arm Type

Experimental

Arm Description

2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 mg oral tablet, 1x 60 min before bedtime for 15 days

Intervention Type

Drug

Intervention Name(s)

Melatonin

Intervention Description

2 Mg Oral Tablet, slow release

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo pill identical to the treatment pill

Primary Outcome Measure Information:

Title

Change in sleep duration

Description

Sleep recorded with a portable device

Time Frame

Change from baseline sleep duration at treatment day 15

Title

Change in wake after sleep onset

Description

Sleep recorded with a portable device

Time Frame

Change from baseline sleep duration at treatment day 15

Title

Change in sleep efficiency

Description

Sleep recorded with a portable device

Time Frame

Change from baseline sleep duration at treatment day 15

Title

Urinary 6-sulfatoxy-melatonin levels

Description

Urinary samples

Time Frame

During sleep periods during the last 3 days of each treatment phase

Secondary Outcome Measure Information:

Title

Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)

Description

Time Frame

Change between treatment conditions in PSQI score at treatment day 15

Title

Nocturnal skin temperature

Description

Skin measured around the nocturnal sleep periods

Time Frame

Change between treatment conditions at bedtime at treatment days 14-15

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diane B Boivin, MD, PhD

Phone

514-761-6131

Ext

2397

diane.boivin@douglas.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane B Boivin, MD, PhD

Organizational Affiliation

Douglas Hospital Research Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Study and Treatment of Circadian Rhythms

City

Montréal

State/Province

Quebec

ZIP/Postal Code

J4J5L8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rafael Pérez Medina Carballo

Phone

514-731-6131

Ext

2395

rafael.perez@douglas.mcgill.ca

12. IPD Sharing Statement

Plan to Share IPD

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Exogenous Melatonin in Postmenopausal Women With Insomnia

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