Insomniac Postmenopausal Women Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment