No More Sleepless Nights in Perimenopause

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 1, 2026

Study Completion Date

January 30, 2027

Conditions
InsomniaMenopause
Interventions
BEHAVIORAL

Cognitive Behavioural Therapy for Insomnia (CBT-I)

CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and sleep hygiene, stimulus control, sleep restriction, relaxation, structured worry time, cognitive restructuring, and relapse prevention are part of the training. Each session will include homework.

DRUG

Hormone Replacement Therapy (HRT)

Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on lipids, glucose, haemostasis. Participants will receive a conventional prescription for the 2 products that are covered by all health insurances in Switzerland.

BEHAVIORAL

Sleep Hygiene

Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.

Trial Locations (1)

3010

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine, Bern

All Listed Sponsors
lead

Insel Gruppe AG, University Hospital Bern

OTHER