Status:
COMPLETED
RESPeRATE for Treatment of Hot Flashes
Lead Sponsor:
University of California, San Francisco
Conditions:
Menopause
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
This is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and effectiveness of a device called RESPeRATE that paces respiration to treat menopausal hot flashes in 12 per...
Detailed Description
This is an uncontrolled pilot trial of the effects of learning paced respiration using RESPeRATE in 12 healthy peri- or postmenopausal women between 40 and 60 years old who report experiencing at leas...
Eligibility Criteria
Inclusion
- Self-report \>4 hot flashes per day or ≥ 30 hot flashes per week.
- Successful completion of a Hot Flash Diary.
- Willingness to attend all visits, fast before blood draws, complete all questionnaires, complete the hot flash diary, wear an ambulatory monitor, collect a 24-hour urine and wear the RESPeRATE for 15 minutes per day.
- Agree not to use therapies that may affect hot flashes during the trial (estrogens, progestins, raloxifene, tamoxifen, clonidine, selective serotonin reuptake inhibitors, relaxation techniques or acupuncture). -
Exclusion
- Inability to sign an informed consent or fill out questionnaires.
- Use of therapies that may affect hot flashes within 4 weeks of entering the trial (estrogens, progestins, raloxifene, tamoxifen, clonidine, selective serotonin reuptake inhibitors, relaxation techniques or acupuncture).
- History of pulmonary disease including emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD).
- Pregnant or breast feeding.
- Any condition that, in the investigator's opinion, would preclude the participant from being able to understand and use the RESPeRATE device or complete the trial, including severe illness, (e.g., active ischemic heart disease/unstable angina, severe congestive heart failure, chronic atrial fibrillation, stroke resulting in permanent impairment, chronic renal failure or sleep paralysis), plans to move, substance abuse, significant psychiatric problems, or dementia.
- Blood pressure during screening of ≤ 100/60 mmHg.
- Current use of any medication prescribed to lower blood pressure.
- \-
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00283231
Start Date
October 1 2005
End Date
February 1 2006
Last Update
May 7 2008
Active Locations (1)
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1
UCSF Women's Health Clinical Research Center
San Francisco, California, United States, 94115