Effect of Estrogen Therapy on Objective Sleep Quality in Postmenopausal Women

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT01501422

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Insomniac Postmenopausal Women	Drug: Estrogen patch Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Estrogen Use estrogen patch for 8 weeks	Drug: Estrogen patch 50 microgram estrogen patch weekly
Experimental: Placebo Use placebo patch for 8 weeks	Drug: Placebo Placebo patch for 8 weeks

Arm

Intervention/Treatment

Experimental: Estrogen

Use estrogen patch for 8 weeks

Drug: Estrogen patch

50 microgram estrogen patch weekly

Experimental: Placebo

Use placebo patch for 8 weeks

Drug: Placebo

Placebo patch for 8 weeks

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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