Sleep Quality in CHIMES (MF101)

March 29, 2007 updated by: Bionovo
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • University of California, San Francisco
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • University of Minnesota Twin Cities Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women between the ages of 40 to 60.
  • Currently receiving medical care from a health care provider.
  • Self-report 5 hot flashes per day or 35 hot flashes per week.
  • Postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 30mlU/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy with FSH levels > 30 mlU/ml.
  • Agree not to start new herbal or dietary supplements and not to change the dose of any currently used herbal or dietary supplements for the duration of the trial.
  • Successful completion of a Hot Flash Diary, a Daily Study Medication Diary and a Bleeding Diary, tolerates placebo, and 80% compliant at run-in.
  • Must have had a mammogram within the last 9 months.
  • Have access to a phone.
  • Provide informed consent.

Exclusion Criteria:

  • Inability to sign an informed consent or fill out questionnaires.
  • History of breast, uterine or ovarian cancer or melanoma.
  • Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
  • Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
  • Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
  • Unexplained abnormal uterine bleeding within six months of enrollment.
  • Pregnancy or lactating.
  • Clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease.
  • History of deep vein thrombosis or pulmonary embolism requiring anticoagulation.
  • Active liver or gallbladder disease.
  • Use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs.
  • Use of raloxifene or tamoxifen within three months of enrollment.
  • Use of another investigational agent within 3 months of enrollment.
  • History of multiple or severe food or medicine allergies.
  • Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Actigraph watch (SleepWatch-O, Ambulatory Monitoring, Inc., Ardsley, NY)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionovo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristine Ensrud, MD, MPH, University of Minnesota Twin Cities Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MF101 Ancillary Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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