Sleeping Through Menopause

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2029

Study Completion Date

January 1, 2030

Conditions
MenopauseInsomnia
Interventions
DRUG

Estrogens and Progestogens

"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."

BEHAVIORAL

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

"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."

All Listed Sponsors
lead

VU University of Amsterdam

OTHER