Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women
- 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.
|Insomniac Postmenopausal Women||Drug: Estrogen patch Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: 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|
- Sleep efficiency (SE) [ Time Frame: 8 months ]Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed.
- Sleep latency (SL) [ Time Frame: 8 months ]Sleep latency is the time period measured from "lights out," or bedtime, to the beginning of sleep.
- Total sleep time (TST) [ Time Frame: 8 months ]TST is amount of actual sleep time in a sleep period.
- Wake time after sleep onset (WASO) [ Time Frame: 8 months ]WASO is the total time of awake occurring between sleep onset and final wake up.
- Number of awakening [ Time Frame: 8 months ]Number of awakening is the number of awakening during onset of sleep and final wake-up.
- Score of two sleep quality assessment questionnaires. [ Time Frame: 8 months ]
- 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.
|Study Start Date:||July 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Use estrogen patch for 8 weeks
Drug: Estrogen patch
50 microgram estrogen patch weekly
Use placebo patch for 8 weeks
Placebo patch for 8 weeks
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501422
|Menopause Clinic, Menopause research unit, King Chulalongkorn Memorial Hospital|
|Pathumwan, Bangkok, Thailand, 10330|
|Principal Investigator:||Pimpika Tansupswatdikul, MD.||Chulalongkorn University|
|Study Chair:||Sukanya Chaikiitisilpa, MD.||Chulalongkorn University|