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Sleep Quality in CHIMES (MF101)

NCT00454441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2007-03-30

No results posted yet for this study

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.

Conditions

  • Sleep Quality
  • Menopausal Symptoms

Interventions

DRUG

MF101

Sponsors & Collaborators

  • Bionovo

    lead INDUSTRY

Principal Investigators

  • Kristine Ensrud, MD, MPH · University of Minnesota Twin Cities Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Completion
2007-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454441 on ClinicalTrials.gov