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RESPeRATE for Treatment of Hot Flashes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00283231
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : May 7, 2008
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 25, 2006
First Posted Date  ICMJE January 27, 2006
Last Update Posted Date May 7, 2008
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2006)
Feasibility will be measured by number of weeks required to enroll 12 participants and the cost of recruitment per participant.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RESPeRATE for Treatment of Hot Flashes
Official Title  ICMJE RESPeRATE (Paced Respiration) for Treatment of Hot Flashes and Menopausal Symptoms
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menopause
Intervention  ICMJE Behavioral: Paced Respiration
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 25, 2006)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Self-report >4 hot flashes per day or ≥ 30 hot flashes per week.
  2. Successful completion of a Hot Flash Diary.
  3. 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.
  4. 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 Criteria:

  1. Inability to sign an informed consent or fill out questionnaires.
  2. 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).
  3. History of pulmonary disease including emphysema, chronic bronchitis, or chronic obstructive pulmonary disease (COPD).
  4. Pregnant or breast feeding.
  5. 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.
  6. Blood pressure during screening of ≤ 100/60 mmHg.
  7. Current use of any medication prescribed to lower blood pressure.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283231
Other Study ID Numbers  ICMJE H5287-27101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Grady, MD, MPH University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP