Sleeping Through Menopause

NCT06306404 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-512071-12-00
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sleepless nights during the menopausal period: what treatment works? About half of the women have trouble sleeping during the years around the menopause, the perimenopause. This is a period characterised by fluctuating sex hormones. Insomnia during the perimenopause can make women more likely to develop more severe climacteric symptoms and other mental health problems. It is therefore important to find the right treatment to treat insomnia. Currently, we do not know what the best treatment is for managing insomnia during the perimenopause. The Sleeping Through Menopause study is the first to evaluate, side by side, two interventions: menopausal hormone therapy (MHT) and combined cognitive behavioural and circadian therapy for insomnia (CBCTi). The study aims to evaluate how well these treatments alleviate insomnia and climacteric symptoms including hot flashes, and by doing so alleviate or prevent other mental health issues. It will also explore how personal factors might affect treatment success. In the study, 222 women with both insomnia and climacteric symptoms will be randomly assigned to one of four groups: MHT, CBCTi, a combination of both MHT and CBCTi, or a group with no treatment. The main goal is to evaluate how each treatment alleviates insomnia after 8 and 15 weeks. Secondary outcomes are sleep quality, climacteric symptoms including hot flashes, mental health, and daily functioning. This study will help us understand the best ways to treat sleep problems during menopause and whether better sleep can improve other mental health and menopausal symptoms as well.

Conditions

Menopause; Insomnia

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable is the difference between the groups in the within-subject change in insomnia severity at T1 (2 months) and T2 (4 months) relative to T0 (baseline).

  The Insomnia Severity Index (ISI) is composed of seven items that evaluate the severity of sleep disturbance during the past 2 weeks. Each item is rated on a five-point Likert scale and the total score indicates the severity of insomnia. The higher the more severe.

  month 2 vs. month 4

Study Arms (4)

MHT

EXPERIMENTAL

Participants will receive the standard care menopausal hormone therapy.

Drug: Estrogens and Progestogens

Sleep modules

EXPERIMENTAL

Participants will receive the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy.

MHT and Sleep modules

EXPERIMENTAL

Participants will receive both the sleep modules, which includes cognitive behavioral therapy for insomnia, and circadian rhythm therapy, and the standard care menopausal hormone therapy.

Drug: Estrogens and Progestogens; Behavioral: Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy

No intervention

NO INTERVENTION

The control group.

Interventions

Estrogens and Progestogens DRUG

Menopausal Hormone Therapy, formerly known as Hormone Replacement Therapy (HRT), is a medical treatment that involves the use of hormones to relieve the symptoms of menopause and to reduce the risk of certain long-term health conditions associated with menopause. Menopause is a natural biological process that occurs when a women's ovaries stop producing effects, and her estrogen and progesteron hormone levels subsequently decrease. MHT typically involves administration of a combination of sec steroids. In this study MHT consists of estradiol transdermal patches (50 mcg (Systen), which provide a stable release of estradiol and lead to more stable blood levels. This is combined with 200 mg progesterone (Utrogestan tablets for 2 weeks) adjusted to the menstrual cycle to prevent endometrium carcinoma according to the international MHT guidelines.

Also known as: Hormone replacement therapy

MHT; MHT and Sleep modules

Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy BEHAVIORAL

CBTi is a guided, internet-based cognitive behavioral therapy program for insomnia, containing information and exercises on sleep. It consists of five online sessions: 1. Psycho-education on sleep, disordered sleep and sleep hygiene (i.e. general guidelines about health and environmental factors influencing sleep), 2. Sleep restriction (i.e. restrict time in bed to the average sleep time) and stimulus control training (i.e. reinforce association of bed with sleeping), 3. Rumination and relaxation techniques, 4. Cognitive restructuring (i.e. changing misconceptions about sleep), 5. Relapse prevention.

MHT and Sleep modules

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 40-55 years old
• Insomnia severity index score =\>10
• Green Climacteric Score =\>13
• Self-considered capability of completing online questionnaires and diaries in Dutch/English
• Presence of a menstruation (whether regular or not) and the last menstruation must be less than 12 months ago

You may not qualify if:

• CBTi treatment in past year
• Bipolar disorder or psychotic disorder
• Contra-indication for Menopausal Hormone Therapy
• Alcohol or drugs dependency (scores of ≥ 20 on the AUDIT and ≥25 on the DUDIT)
• Women using thyroid medication, lamotrigine, aromatase, tamoxifen, because of interaction effects with MHT
• Use of drugs known to interfere with cytochrome P450 enzyme (CYP) 3A4
• Known hypersensitivity to the excipients in the estradiol patch: acrylate copolymer, polyethylene terephthalate, alfa-tocopherol, soy allergy (component of progesterone capsule).
• All women on hormonal contraceptives will be excluded.
• All women already on MHT will be excluded.

Sponsors & Collaborators

• VU University of Amsterdam: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Estrogens; Progestins; Hormone Replacement Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Drug Therapy; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Birit Broekman, Prof.

  OLVG and Amsterdam UMC, VU

  PRINCIPAL INVESTIGATOR

• Eus van Someren, Prof.

  Netherlands Institute for Neuroscience

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie Koning, Dr.

CONTACT

+31 20 566 5500; a.koning@nin.knaw.nl

Francesca van Baarzel, MSc.

CONTACT

+31 20 566 5500; f.van.baarzel@nin.knaw.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. MD

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share