Insomniac Postmenopausal Women
Conditions
Keywords
postmenopause, sleep quality, estrogen, objective sleep quality, actigraph
Brief summary
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.
Detailed description
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.
Interventions
DRUGEstrogen patch
50 microgram estrogen patch weekly
DRUGPlacebo
Placebo patch for 8 weeks
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency (SE) | 8 months | Sleep efficiency is proportion of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency (SL) | 8 months | Sleep latency is the time period measured from lights out, or bedtime, to the beginning of sleep. |
| Total sleep time (TST) | 8 months | TST is amount of actual sleep time in a sleep period. |
| Wake time after sleep onset (WASO) | 8 months | WASO is the total time of awake occurring between sleep onset and final wake up. |
| Number of awakening | 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. | 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. |
Countries
Thailand
Outcome results
None listed