Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283231
Status:
COMPLETED
Last Update Posted:
2008-05-07
First Post:
2006-01-25
Brief Title:
RESPeRATE for Treatment of Hot Flashes
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
RESPeRATE Paced Respiration for Treatment of Hot Flashes and Menopausal Symptoms
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None