Effects of estrogen therapy on postmenopausal sleep quality regardless of vasomotor symptoms: a randomized trial

OBJECTIVE: To determine the effects of estrogen therapy on objective sleep quality in insomniac postmenopausal women without severe vasomotor symptoms and/or recognized hot flushes during sleep. Study design Randomized, double-blinded, placebo-controlled trial, parallel design (ClinicalTrials.gov Identifier: NCT01501422). METHODS: Forty insomniac postmenopausal women with no severe vasomotor symptoms and/or recognized hot flushes during sleep were randomized into 2 months' treatment with a 50-μg transdermal estradiol patch or placebo. Sleep quality was determined objectively with wrist actigraphy. Sleep efficiency, total sleep time, wake up after sleep onset and number of awakenings were compared before and after treatment. The Insomnia Severity Index (ISI) and Epworth Sleepiness Scale (ESS) questionnaires were used for subjective sleep quality assessment before and after treatment. RESULTS: The study showed no significant difference in sleep efficiency improvement between women having estrogen alone or placebo (median 85.7% vs. 85.2%, respectively, p = 0.71). Similarly, sleep quality scores assessed by ISI and ESS were not significantly different. CONCLUSION: Estrogen therapy in insomniac postmenopausal women without severe vasomotor symptoms and/or recognized hot flushes during sleep was not found to improve sleep efficiency during the study period.