Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
2012年12月26日 更新者：Pimpika Tansupswatdikul, MD.、Chulalongkorn University
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial
- Sex hormone including estrogen have synergistic effect to serotonin activity and decrease activity of monoamine oxidase activity so the norepinephrine is not be metabolized, these substance are important to regulate hemostasis and circadian process of sleep
Estrogen also regulate gamma-aminobutyric acid (GABA) secretion
- GABA substance is in order to initiate sleep and continue sleep
- According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match)
- This research perform to find out the actual effect of estrogen in improving sleep quality.
研究概览
详细说明
- 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project
Block of four randomization was use to categorize participants into 2 groups
- Study group (estrogen patch)
- Control group (placebo patch)
Sleep quality was measured before intervention by subjective and objective sleep quality
- Subjective sleep quality (self sleep questionnaire)
- Objective sleep quality (wrist actigraphy and sleep diary):
wrist actigraph sleep test at home for 1 week
Intervention phase : continuous use of weekly patch for 8 weeks
- Estrogen patch in study group
- Placebo patch in control group
Follow up phase
- At 4 weeks of use, investigator will telephone call for follow up the participant's compliance and the side effects during patch use.
- After completed use of 7th patch, sleep quality was measured again, self sleep quality questionnaire and 1 week-wrist actigraphy and sleep diary test
- Then the data will be analysed and open label, in nonhysterectomized postmenopausal women in study group will take the medroxyprogesterone acetate for washing out the endometrium for 2 weeks
- The participants will be counseled, further investigate and proper treatment.
研究类型
介入性
注册 (实际的)
40
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Bangkok
-
Pathumwan、Bangkok、泰国、10330
- Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 60年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Postmenopausal women 40-60 years old
- Mild to moderate vasomotor symptom
- Insomnia
- fluent read and write in Thai language
- Inform consent
Exclusion Criteria:
- Acute liver and gall bladder disease
- undiagnosed abnormal bleeding per vagina
- History of BIRADs 3 from mammogram
- History or current venous thrombosis, embolism
- diagnosis of sleep disorder
- use of hypnotic drug or antihistamine in the past month
- Diagnosis of psychiatric disorder such as depressive disorder, schizophrenia, anxiety disorder
- No past history of malignancy
- No history of chronic renal disease, alzheimer's disease, uncontrolled hypertension, uncontrolled diabetes mellitus
- history of estrogen use in past 6 months
- drug abuse, Alcohol
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Estrogen
Use estrogen patch for 8 weeks
|
50 microgram estrogen patch weekly
|
|
实验性的：Placebo
Use placebo patch for 8 weeks
|
Placebo patch for 8 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep efficiency (SE)
大体时间：8 months
|
Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.
|
8 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep latency (SL)
大体时间：8 months
|
Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.
|
8 months
|
|
Total sleep time (TST)
大体时间：8 months
|
TST is amount of actual sleep time in a sleep period.
|
8 months
|
|
Wake time after sleep onset (WASO)
大体时间：8 months
|
WASO is the total time of awake occurring between sleep onset and final wake up.
|
8 months
|
|
Number of awakening
大体时间：8 months
|
Number of awakening is the number of awakening during onset of sleep and final wake-up.
|
8 months
|
|
Score of two sleep quality assessment questionnaires.
大体时间：8 months
|
|
8 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pimpika Tansupswatdikul, MD.、Chulalongkorn University
- 学习椅：Sukanya Chaikiitisilpa, MD.、Chulalongkorn University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kalleinen N, Polo O, Himanen SL, Joutsen A, Polo-Kantola P. The effect of estrogen plus progestin treatment on sleep: a randomized, placebo-controlled, double-blind trial in premenopausal and late postmenopausal women. Climacteric. 2008 Jun;11(3):233-43. doi: 10.1080/13697130802112033.
- Huang KE, Baber R; Asia Pacific Tibolone Consensus Group. Updated clinical recommendations for the use of tibolone in Asian women. Climacteric. 2010 Aug;13(4):317-27. doi: 10.3109/13697131003681458.
- Halbreich U, Kahn LS. Role of estrogen in the aetiology and treatment of mood disorders. CNS Drugs. 2001;15(10):797-817. doi: 10.2165/00023210-200115100-00005.
- Shanafelt TD, Barton DL, Adjei AA, Loprinzi CL. Pathophysiology and treatment of hot flashes. Mayo Clin Proc. 2002 Nov;77(11):1207-18. doi: 10.4065/77.11.1207. Erratum In: Mayo Clin Proc. 2004 Aug;79(8):1088.
- Sarti CD, Chiantera A, Graziottin A, Ognisanti F, Sidoli C, Mincigrucci M, Parazzini F; Gruppo di Studio IperAOGOI. Hormone therapy and sleep quality in women around menopause. Menopause. 2005 Sep-Oct;12(5):545-51. doi: 10.1097/01.gme.0000172270.70690.5e. Epub 2005 Sep 1.
- Wiklund I, Berg G, Hammar M, Karlberg J, Lindgren R, Sandin K. Long-term effect of transdermal hormonal therapy on aspects of quality of life in postmenopausal women. Maturitas. 1992 Mar;14(3):225-36. doi: 10.1016/0378-5122(92)90117-m.
- Polo-Kantola P, Erkkola R, Helenius H, Irjala K, Polo O. When does estrogen replacement therapy improve sleep quality? Am J Obstet Gynecol. 1998 May;178(5):1002-9. doi: 10.1016/s0002-9378(98)70539-3.
- Saletu B. Sleep, vigilance and cognition in postmenopausal women: placebo-controlled studies with 2 mg estradiol valerate, with and without 3 mg dienogest. Climacteric. 2003 Aug;6 Suppl 2:37-45.
- Ensrud KE, Stone KL, Blackwell TL, Sawaya GF, Tagliaferri M, Diem SJ, Grady D. Frequency and severity of hot flashes and sleep disturbance in postmenopausal women with hot flashes. Menopause. 2009 Mar-Apr;16(2):286-92. doi: 10.1097/gme.0b013e31818c0485.
- Tranah GJ, Parimi N, Blackwell T, Ancoli-Israel S, Ensrud KE, Cauley JA, Redline S, Lane N, Paudel ML, Hillier TA, Yaffe K, Cummings SR, Stone KL. Postmenopausal hormones and sleep quality in the elderly: a population based study. BMC Womens Health. 2010 May 4;10:15. doi: 10.1186/1472-6874-10-15.
- Tansupswatdikul P, Chaikittisilpa S, Jaimchariyatam N, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effects of estrogen therapy on postmenopausal sleep quality regardless of vasomotor symptoms: a randomized trial. Climacteric. 2015 Apr;18(2):198-204. doi: 10.3109/13697137.2014.964670. Epub 2014 Nov 27.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年7月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年11月14日
首先提交符合 QC 标准的
2011年12月24日
首次发布 (估计)
2011年12月29日
研究记录更新
最后更新发布 (估计)
2012年12月28日
上次提交的符合 QC 标准的更新
2012年12月26日
最后验证
2012年12月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MRU CU-1/2011
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.