menopausal symptoms/chronic insomnia disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients who have subjective insomnia scoring 6 or more on the Athens Insomnia Scale and are diagnosed with chronic insomnia disorder by ICSD-3 defnition
Exclusion criteria
Exclusion criteria: women who are already treated with estrogens, antidepressants, anxiolytics, hypnotics etc. that are supposed to have effects on insomnia symptoms in middle-aged women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in objective sleep parameters measured by actigraphy after 12 and 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in Pittsburgh Sleep Quality Index, Athens Insomnia Scale, Epworth Sleepiness Scale, St. Marys Hospital Sleep Questionnaire, Menopause Health Related Quality of Life Questionnaire, and Hospital Anxiety and Depression Scale after 12 and 24 weeks of treatment | — |
Countries
Japan
Contacts
Tokyo Medical and Dental University Department of Women's Health