RESPeRATE for Treatment of Hot Flashes
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||RESPeRATE (Paced Respiration) for Treatment of Hot Flashes and Menopausal Symptoms|
- 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.
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||February 2006|
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.
|United States, California|
|UCSF Women's Health Clinical Research Center|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Deborah Grady, MD, MPH||University of California, San Francisco|