1. 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 2. Estrogen also regulate gamma-aminobutyric acid (GABA) secretion * GABA substance is in order to initiate sleep and continue sleep 3. According to epidemiologic data, problem of sleep was increasing in postmenopause group compare to premenopause group (aged-match) 4. This research perform to find out the actual effect of estrogen in improving sleep quality.
1. 40-60 year-old postmenopausal women with insomnia and mild-moderate vasomotor symptom were screened and included in project 2. Block of four randomization was use to categorize participants into 2 groups * Study group (estrogen patch) * Control group (placebo patch) 3. 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 5. 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 6. 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 7. The participants will be counseled, further investigate and proper treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
50 microgram estrogen patch weekly
Placebo patch for 8 weeks
Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, Thailand
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.
Time frame: 8 months
Sleep latency (SL)
Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.
Time frame: 8 months
Total sleep time (TST)
TST is amount of actual sleep time in a sleep period.
Time frame: 8 months
Wake time after sleep onset (WASO)
WASO is the total time of awake occurring between sleep onset and final wake up.
Time frame: 8 months
Number of awakening
Number of awakening is the number of awakening during onset of sleep and final wake-up.
Time frame: 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.
Time frame: 8 months
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