JMIR Publications

ABSTRACT

Background:

Perimenopausal insomnia (PMI) is common in middle-aged women and is more severe than non-menopausal insomnia. Acupuncture is safe and may be effective for PMI and the American Association of Physicians (ACP) recommends cognitive behavioral therapy (CBT) as a first-line treatment for insomnia (CBT-I). However, few randomized controlled trials have been conducted to compare the effectiveness of these two therapies.

Objective:

To compare the preliminary effectiveness and safety of electroacupuncture (EA) and CBT-I for PMI through a randomized, controlled, non-inferior study design.

Methods:

This study is designed as an assessor-blinded, non-inferiority, randomized controlled trial. A total of 160 eligible participants with PMI will be randomly divided into two groups to receive either EA or CBT-I. Participants in the EA group will receive electroacupuncture for 8 weeks, while those in the control group will undergo CBT-I (once a week) for 8 weeks. The primary outcome is the Insomnia Severity Index. The secondary outcome measures are the Pittsburgh Sleep Quality Index, Menopause-Specific Quality of Life, Menopause Rating Scale, Hamilton Depression Scale, Hamilton Anxiety Scale, Hot-flash score, and the level of estradiol, follicle-stimulating hormone, and luteinizing hormone in serum. Sleep architecture will be assessed using polysomnograms.

Results:

Participants are being recruited. The first participant was enrolled in January 2023. The recruitment is expected to end in January 2025.

Conclusions:

This will be the first trial to study the efficacy and safety of EA or CBT-I for perimenopausal insomnia.One limitation is that this study is implemented in only onecentre in Chinese participants.The results of this study will provide knowledge for clinicians in the treatment of perimenopausal insomnia. Clinical Trial: ChiCTR2300070981