The Effect of Menopausal Hormone Therapy on Sleep (menoSLEEP) study is investigating the effects of menopausal hormone therapy (MHT) on sleep problems in peri- and postmenopausal women with an indication for MHT. The aim of the study is to find out whether MHT improves subjective and objective sleep quality in these women. The primary objective is to measure sleep quality using several sleep-specific questionnaires and a sleep protocol.
The study is a multicentre, prospective, unblinded, randomised controlled trial involving 172 women. Participants will be divided into groups that will either receive MHT or act as a control group. All participants will complete seven questionnaires before and after MHT and keep a sleep diary. The duration of participation will vary between 8 and 16 weeks. The results should help to improve the treatment of menopausal sleep disorders and the quality of life of women affected.