An interventional study of Paced Respiration in Menopause, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-05-07.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
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 least 4 hot flashes per day or 30 hot flashes per week. Participants will be screened by telephone, then attend a clinic visit for further screening, and a baseline visit for final eligibility assessment and to learn how to use the RESPeRATE. Participants will receive information about the use of the RESPeRATE and paced respiration from a trained staff member and practice using the RESPeRATE during the clinic visit. Participants will also be instructed how to record hot flashes in a diary. The intervention will consist of using the RESPeRATE device for 15 minutes daily. Outcomes will be assessed in the clinic after 3 weeks and 6 weeks use of the device. The main efficacy outcomes are change in number of hot flashes per week and change in hot flash score (number of flashes x mean severity) from baseline to 3 and 6 weeks post-training, reported on the 7-day diary. Frequency of hot flashes will also be measured at baseline and 6 weeks using a 24-hour ambulatory hot flash monitor. Change in breathing rate will be calculated from baseline to 3 and 6 weeks and changes in sleep and quality of life from baseline to 6 weeks as measured by validated self-administered questionnaires. The mechanism of response to the RESPeRATE will be explored by measuring blood pressure at baseline, 3 weeks and 6 weeks and, body mass index and 24-hour levels of urinary epinephrine, norepinephrine and cortisol at baseline and 6 weeks. We will also draw a fasting blood sample at baseline and 6 weeks to measure serum lipids, glucose and insulin.
285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 255 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current use of any medication prescribed to lower blood pressure.
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The efficacy of the intervention for reduction of number and severity of hot flashes will be summarized by the sample averages, with 95% confidence intervals.
We will also perform a paired t-test of the baseline and post-treatment values.
Feasibility will be measured by number of weeks required to enroll 12 participants and the cost of recruitment per participant.
This study is completed, as verified in Jul 2005. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco