drugset / Trial / NCT00454441

Sleep Quality in CHIMES (MF101)

NCT00454441 ↗

Phase 2 Completed 180 enrolled Bionovo
RandomizedSingle-groupDouble-blindTreatment

Summary

Menopausal women often complain of difficulty sleeping and the transition from pre- to postmenopausal status is associated with an incresase in self-reported sleep disturbance. Hot flashes have been associated with self-reported measures of sleep disturbance and changes in sleep pattern as measured by plysomnography, including an increase in stage 4 and a latency or shortened time in rapid-eye movement sleep. Although there are some data on the effect of hormone replacement therapy on self-reported sleep measures in symptomatic postmenopausal women, there are no data on the effect of herbal extracts on subjective or objective measures of sleep quality in this population group. Actigraphy, the use of a device to record movement generally placed on the wrist, has been used over 20 years to provide objective data concerning sleep/wake patterns. The advantage of actigraphy over traditional polysomnography is that actigraphy can conveniently record continuously for 24-hours a day for longer periods of time.

Timeline

Start
2006-02
Primary completion
—
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject MF101 Traditional medicine (herbal / TCM) — —