NCT01501422已完成3 期
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sleep efficiency (SE)
研究概览
简要总结
- 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.
详细描述
- 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 4. Intervention phase : continuous use of weekly patch for 8 weeks
- Estrogen patch in study group
- Placebo patch in control group
- Follow up phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women 40-60 years old
- •Mild to moderate vasomotor symptom
- •fluent read and write in Thai language
- •Inform consent
排除标准
- •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
研究组 & 干预措施
Estrogen
Experimental
Use estrogen patch for 8 weeks
干预措施: Estrogen patch (Drug)
Placebo
Experimental
Use placebo patch for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Sleep efficiency (SE)
时间窗: 8 months
Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.
次要结局
- Sleep latency (SL)(8 months)
- Total sleep time (TST)(8 months)
- Number of awakening(8 months)
- Score of two sleep quality assessment questionnaires.(8 months)
- Wake time after sleep onset (WASO)(8 months)
研究者
Pimpika Tansupswatdikul, MD.
Principle investigator
Chulalongkorn University
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Can Hormome replacement therapy of menopause improve sleep and quality of life in menopausal women with Fibromyalgia?Fibromyalgia, Menopause, Sleep-Wake disordersC05.651.324G08.686.157.500C10.886RBR-24bbzsHospital de Clínicas da Universidade Federal do Paraná
已完成
不适用
Estrogen and Serotonin on Changing Brain ChemistryMenopauseNCT01208324University of Colorado, Denver47
招募中
4 期
Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife WomenEstrogenPremenopauseNCT06745466University of Delaware30
已完成
4 期
Sex Steroids and the Serotonin TransporterTranssexualismNCT01065220Medical University of Vienna32
Unknown
4 期
Effects of Sex Steroids on the Serotonin SystemGender DysphoriaNCT02715232Medical University of Vienna92