Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women at Menopause Clinic, King Chulalongkorn Memorial Hospital, Double- Blind, Randomized, Placebo-controlled Trial

Conditions
-----------------
Insomniac Postmenopausal Women

Intervention / Treatment
-----------------
* Drug: Estrogen patch
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estrogen<br>Use estrogen patch for 8 weeks | Drug: Estrogen patch<br>* 50 microgram estrogen patch weekly<br>|
| Experimental: Placebo<br>Use placebo patch for 8 weeks | Drug: Placebo<br>* Placebo patch for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency (SE) | Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep latency (SL) | Sleep latency is the time period measured from lights out, or bedtime, to the beginning of sleep. | 8 months | 
| Total sleep time (TST) | TST is amount of actual sleep time in a sleep period. | 8 months | 
| Wake time after sleep onset (WASO) | WASO is the total time of awake occurring between sleep onset and final wake up. | 8 months | 
| Number of awakening | 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. | Insomnia severity index is the 7 topic questionnaire for determine the severity of insomnia problem. Ebworth severity index is the questionnaire to assess daytime sleepiness. | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopause, sleep quality, estrogen, objective sleep quality, actigraph