Sleep Quality in CHIMES (MF101)

Sleep Quality Clinical Trial

Official title: Sleep Quality in CHIMES (MF101)

Status Completed

Clinical Trial 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.

Clinical Trial Description

Specific Aims:

1. To determine the effect of MF101 (a combination of Chinese herbs) compared to placebo on change in sleep quality utilizing baseline and follow-up actigraphy obtained from a subset of approximately 90 women enrolled in the randomized, double-blind, placebo-controlled Chinese Herbs for Menopausal Symptoms (CHIMES) trial.

2. TO identify the correlates of sleep quality as assessed by actigraphy in women with frequent hot flashes. We will evaluate demographic, lifestyle, anthropometric, medical and gynecologic history and hormonal factors that may relate to the actigraphic measures of sleep quality, including self-reported measures of sleep. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menopausal Symptoms
• Sleep Quality

• NCT number: NCT00454441
• Study type: Interventional
• Source: Bionovo
• Status: Completed
• Phase: Phase 2
• Start date: February 2006
• Completion date: February 2007