Perimenopausal Insomnia
Conditions
Interventions
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the International Classification of Sleep Disorders (Third Edition) criteria for insomnia disorder; 2.Women aged 40 to 60 years; 3.According to STRAW+10, signs of menopausal tendency began to appear from clinical features, endocrinology and biology until 1 year after final menopause; 4.Insomnia lasts for at least 3 months; 5.The total score of the Insomnia Severe Index (ISI) is greater than 14; 6.Be willing to participate in the investigation and provide written informed consent before the clinical trial starts.
Exclusion criteria
Exclusion criteria: 1.Use of menopause hormone therapy, sedative or anti-anxiety drugs; 2.Non-natural menopause (due to surgery, radiation); 3.Having any external factors which can cause sleep disturbance; 4.Unknown causes of vaginal hemorrhage; 5.Having mental illness or any serious physical illness; 6.Having received or currently receiving CBT or acupuncture for insomnia; 7.Participation in any other clinical trial within the last 6 months; 8. Pregnant women or women in lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Menopause Rating Scale;Menopause-Specific Quality of Life;Hamilton Anxiety Scale;Hamilton Depression Scale;Polysomnography;serum sex hormone;hot flash score; | — |
Countries
China
Contacts
Public ContactYu Xintong
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed