RESPeRATE for Treatment of Hot Flashes

Completed · Not applicable

Conditions studied: Menopause

In brief

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 peri- or postmenopausal women. Participants will practice paced respiration for 15 minutes everyday for six weeks and attend assessment visits at weeks 3 and 6.

Key facts

Study ID

NCT00283231

Run by

University of California, San Francisco

People needed

12

Starts

2005-10-01

Expected to finish

2006-02-01

Last updated by the study team

2008-05-07

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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). -

You may not qualify if…

• 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.

Where it is running

• UCSF Women's Health Clinical Research Center — San Francisco, California, United States

Full record on ClinicalTrials.gov

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