Clinical trial NCT06117969: the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
Official title: A Prospective Randomized Controlled Study of the Effects of Different Therapy Regimens on Menopausal Sleep Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Menopause
Sleep Disorder
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 180
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleeping disorders are one of the most common menopausal symptoms, which seriously affect health and life quality of perimenopausal women. Menopausal hormone therapy is an effective treatment for menopausal symptoms, meanwhile, traditional Chinese medicine is also effective to some extent. This prospective randomized controlled study plan to compare the effects of different therapy regimens, including Tibolone and Xiangshao granules, on menopausal sleep disorders.


Eligibility criteria: Inclusion Criteria:

* women aged 40-60
* natural menopause for 1-10 years
* PSQI score \>=11 points
* improved K-score\>=14 points
* able to independently sign informed consent forms

Exclusion Criteria:

* Vaginal bleeding of unknown cause
* Known or suspected breast cancer and other sex hormone dependent tumors
* Active venous or arterial thromboembolic disease within past 6 months
* Have used sex hormone or traditional Chinese medicine/botanical drugs that affect menopausal symptoms within the past month
* Have used anti anxiety, depression drugs or sedative hypnotics within the past month
* Patients with anxiety or depression above moderate level
* Severe liver or kidney dysfunction, with transaminase or creatinine level exceeding twice of the normal value
* BMI ≥ 28 kg/m2
* Allergies to research drugs
* Other situations that doctor deems unsuitable to participate in the study

Primary outcomes:
measure: Polysomnography (PSG)
timeFrame: V0(screening period), V3(week 8)
measure: Pittsburgh Sleep QualityIndex questionnaire (PSQI questionnaire)
timeFrame: V0(screening period), V2(week 4), V3(week 8)
measure: Sleep diary
timeFrame: V0(screening period), V1（dsy 1）, V2(week 4), V3(week 8)
Secondary outcomes:
measure: Improved Kupperman score
timeFrame: V0(screening period), V2(week 4), V3(week 8)
measure: Menopause-specific Quality of Life Scale
timeFrame: V0(screening period), V2(week 4), V3(week 8)
measure: Self-Rating Anxiety Scale
timeFrame: V0(screening period), V2(week 4), V3(week 8)
measure: Center for Epidemiological Survey Depression Scale (CES Depression Scale)
timeFrame: V0(screening period), V2(week 4), V3(week 8)
Other outcomes:
Locations:
Study officials:
affiliation: Peking Union Medical College Hospital
name: Rong Chen, Professor
role: STUDY_DIRECTOR
References:
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citation: Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
citation: Kaplan KA, Hardas PP, Redline S, Zeitzer JM; Sleep Heart Health Study Research Group. Correlates of sleep quality in midlife and beyond: a machine learning analysis. Sleep Med. 2017 Jun;34:162-167. doi: 10.1016/j.sleep.2017.03.004. Epub 2017 Mar 27.
citation: Kenemans P, Speroff L; International Tibolone Consensus Group. Tibolone: clinical recommendations and practical guidelines. A report of the International Tibolone Consensus Group. Maturitas. 2005 May 16;51(1):21-8. doi: 10.1016/j.maturitas.2005.02.011.
citation: Jiang XR, Ren L, Li CR. [Effect of Electroacupuncture on Hypothalamus-Pituitary-Ovary (HPO) Axis in Rats with Peri-menopausal Depression]. Zhen Ci Yan Jiu. 2017 Feb 25;42(1):45-9. Chinese.
citation: Chen R, Tang R, Zhang S, Wang Y, Wang R, Ouyang Y, Xie X, Liu H, Lv S, Shi H, Zhang Y, Xie M, Luo Y, Yu Q. Xiangshao granules can relieve emotional symptoms in menopausal women: a randomized controlled trial. Climacteric. 2021 Jun;24(3):246-252. doi: 10.1080/13697137.2020.1820476. Epub 2020 Oct 5.