Sleeping Through Menopause

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorVU University of Amsterdam

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Estrogens and Progestogens
  • Cognitive behavioral therapy for insomnia (CBTi), and circadian rhythm therapy

Treatment groups

222 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators