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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01466998
Other study ID # R01AT005491
Secondary ID
Status Completed
Phase N/A
First received November 1, 2011
Last updated May 5, 2014
Start date January 2012
Est. completion date April 2014

Study information

Verified date May 2014
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Hot flashes occur in as many as two thirds of U.S. women during menopause and are severe enough to require treatment in 20%. Although postmenopausal hormone therapy is effective in suppressing hot flashes, it is associated with increased risk for a variety of serious adverse effects. There is an urgent need for alternative treatments that are effective, safe, and easy to use. In this study, the investigators will compare two different types of behavioral relaxation therapies, paced respiration and music therapy, for treatment of menopausal hot flashes. Effects on frequency of hot flashes, other symptom and quality-of-life outcomes associated with hot flashes, and physiologic measures of sympathetic/parasympathetic activity will be examined.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 59 Years
Eligibility Inclusion Criteria

1. Women aged 40 through 59 years at the time of screening.

2. Perinenopausal or postmenopausal.

3. Adequate adherence to study procedures during a 1-week run-in.

4. At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.

5. Capable of understanding study procedures and giving informed consent.

6. Willing to refrain from using other treatments for hot flashes during the study period.

Exclusion criteria

1. Pregnant or breastfeeding in the past year.

2. Current or recent use of medications known to affect hot flashes.

3. Resting blood pressure less than 100/60.

4. Spontaneous resting breathing rate less than 10 breaths/minute.

5. Chronic medical therapy for pulmonary disease.

6. Known sensitivity to adhesives.

7. Cardiac pacemaker or implanted defibrillator.

8. No access to a telephone.

9. Plans to move out of the area or travel by airplane in ways that would interfere with the study.

10. Inability to sign an informed consent, participate in interviews, or understand and complete questionnaires in English.

11. Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol.

12. Participation in another research study involving investigational drugs or devices.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Paced Respiration
Practice paced respiration 15 minutes per day for a total of 12 weeks.
Music Therapy
Practice music therapy for 15 minutes per day for a total of 12 weeks.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in average daily frequency of hot flashes. 4-Weeks and 12-Weeks No
Secondary Change in subjective severity of hot flashes. 4-weeks and 12-weeks No
Secondary Change in sympathetic and parasympathetic autonomic nervous system tone. 12 weeks No
Secondary Change in quality-of-of life measures associated with hot flashes. Weeks 4 and Weeks 12 No
See also
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Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
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