RESPeRATE for Treatment of Hot Flashes

NCT00283231 | Completed

• 1 other identifier: H5287-27101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Hot Flashes; Menopausal Symptoms; Paced respiration; RESPeRATE

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Feasibility will be measured by number of weeks required to enroll 12 participants and the cost of recruitment per participant.

Interventions

Paced Respiration BEHAVIORAL

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Women's Health Clinical Research Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deborah Grady, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2006
• First Posted: January 27, 2006
• Study Start: October 1, 2005
• Study Completion: February 1, 2006
• Last Updated: May 7, 2008

Record last verified: 2005-07

Locations

US (1)