Hot FlushesMaTURENCT01466998
Menopausal Treatment Using Relaxation Exercises (MaTURE)
A study testing Paced Respiration and Music Therapy in people with Hot Flushes and Hot Flashes, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flushes, Hot Flashes
- What is being tested?
- Paced Respiration and Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 40 through 59 years at the time of screening.
- Perinenopausal or postmenopausal.
- Adequate adherence to study procedures during a 1-week run-in.
- At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.
- Capable of understanding study procedures and giving informed consent.
- Willing to refrain from using other treatments for hot flashes during the study period.
Who cannot join
- Pregnant or breastfeeding in the past year.
- Current or recent use of medications known to affect hot flashes.
- Resting blood pressure less than 100/60.
- Spontaneous resting breathing rate less than 10 breaths/minute.
- Chronic medical therapy for pulmonary disease.
- Known sensitivity to adhesives.
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- Cardiac pacemaker or implanted defibrillator.
- No access to a telephone.
- Plans to move out of the area or travel by airplane in ways that would interfere with the study.
- Inability to sign an informed consent, participate in interviews, or understand and complete questionnaires in English.
- Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol.
- Participation in another research study involving investigational drugs or devices.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
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.
- Conditions
- Hot Flushes, Hot Flashes
- Being tested
- Paced Respiration, Music Therapy
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced RespirationOther
Practice paced respiration 15 minutes per day for a total of 12 weeks.
Music TherapyOther
Practice music therapy for 15 minutes per day for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Paced Respiration | Experimental | Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Receives: Other: Paced Respiration |
| Music Therapy | Active comparator | Participant will use an identical appearing device, programmed to play quiet, relaxing non-rhythmic music while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average daily frequency of hot flashes.
Measured: 4-Weeks and 12-Weeks
Secondary outcomes (3)
Change in subjective severity of hot flashes.
Measured: 4-weeks and 12-weeks
Change in sympathetic and parasympathetic autonomic nervous system tone.
Measured: 12 weeks
Change in quality-of-of life measures associated with hot flashes.
Measured: Weeks 4 and Weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlushesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Deborah Grady, University of California, San Francisco
- Investigators
- Deborah Grady, MD, MPH, Principal investigator, University of California, San FranciscoAlison Huang, MD, MAS, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466998
- Sponsor's protocol ID
- R01AT005491
- Acronym
- MaTURE
- Status last verified
- May 2014
- First submitted
- 1 Nov 2011
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang AJ, Phillips S, Schembri M, Vittinghoff E, Grady D. Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1130-1138. doi: 10.1097/AOG.0000000000000821.
PubMed 25932840
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Treatment Using Relaxation Exercises (MaTURE)
- ClinicalTrials.gov ID
- NCT01466998
- Acronym / sponsor ID
- MaTURE / R01AT005491
- Conditions
- Hot Flushes, Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paced Respiration | Experimental | Other: Paced RespirationParticipants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
| Music Therapy | Active comparator | Other: Music TherapyParticipant will use an identical appearing device, programmed to play quiet, relaxing non-rhythmic music while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 40 through 59 years at the time of screening.
- Perinenopausal or postmenopausal.
- Adequate adherence to study procedures during a 1-week run-in.
- At least 4 hot flashes per 24 hours recorded by a hot flash monitor and diary.
- Capable of understanding study procedures and giving informed consent.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding in the past year.
- Current or recent use of medications known to affect hot flashes.
- Resting blood pressure less than 100/60.
- Spontaneous resting breathing rate less than 10 breaths/minute.
- Chronic medical therapy for pulmonary disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paced RespirationPractice paced respiration 15 minutes per day for a total of 12 weeks. | Other | Paced Respiration |
| Music TherapyPractice music therapy for 15 minutes per day for a total of 12 weeks. | Other | Music Therapy |
Primary outcome
Change in average daily frequency of hot flashes.
Time frame: 4-Weeks and 12-Weeks
3 secondary outcomes
Change in subjective severity of hot flashes.
Time frame: 4-weeks and 12-weeks
Change in sympathetic and parasympathetic autonomic nervous system tone.
Time frame: 12 weeks
Change in quality-of-of life measures associated with hot flashes.
Time frame: Weeks 4 and Weeks 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Derived from this study: PubMed 25932840Huang AJ, Phillips S, Schembri M, Vittinghoff E, Grady D. Device-guided slow-paced respiration for menopausal hot flushes: a randomized controlled trial. Obstet Gynecol. 2015 May;125(5):1130-1138. doi: 10.1097/AOG.0000000000000821.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Grady, MD, MPH principal investigator
University of California, San Francisco
Alison Huang, MD, MAS study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paced Respiration and Music Therapy in people with Hot Flushes and Hot Flashes, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average daily frequency of hot flashes. (time frame: 4-Weeks and 12-Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01466998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.