No More Sleepless Nights in Perimenopause

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "No More Sleepless Nights in Perimenopause," is exploring how effective two treatments—Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I)—are in helping menopausal women who struggle with insomnia. The researchers want to find out if these treatments can improve sleep and if one is better than the other. To do this, they will also compare these therapies to a group that receives general advice on sleep hygiene, which includes tips for better sleep habits.

To be eligible for this trial, participants should be women in the later stages of menopause and experiencing significant sleep issues, as indicated by specific sleep assessments. The trial will involve an 8-week program where participants will either receive HRT, attend weekly CBT-I sessions, or learn about sleep hygiene. They will keep a daily sleep diary and wear a device that monitors their sleep patterns for several nights. Participants will also have follow-up assessments to see how well the treatments worked. This trial is currently not recruiting participants, but it's designed to help find better solutions for those dealing with insomnia during menopause.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
• • Pittsburgh Sleep Quality Index (PSQI) score \> 5
• • Insomnia Severity Index (ISI) score \> 7
• • Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
• • Willingness to use HRT for menopausal symptom reliefs
• Exclusion Criteria:
• • Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
• • Untreated hormonal disorder
• • Obesity (BMI ≥ 30)
• • Current psychotherapy
• • Current psychopharmacological therapy including regular sleep medication
• • History of unsuccessful CBT-I
• • Psychiatric illness
• • Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
• • Shift work
• • Long-haul flights across different time zones in the past 3 months
• • Pregnancy and lactation
• • Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
• • Inability to follow procedures or insufficient knowledge of project language
• • Inability to give consent