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Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

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: NCT03937466
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The purposes of this study are to obtain preliminary evidence on the efficacy of a cooling mattress pad in reducing subjective hot flashes for peri and postmenopausal women experiencing menopausal hot flashes, and to obtain preliminary evidence on the efficacy of a cooling mattress pad for improving sleep for peri and postmenopausal women experiencing menopausal hot flashes.

Condition or disease Intervention/treatment Phase
Hot Flashes Menopause Device: Cooling mattress pad Not Applicable

Detailed Description:
Women will be recruited from the community through flyers. They will call into a study phone line at which time they will be screened for their initial eligibility using a telephone screener. Women who are eligible and willing to participate, will come to the Research Center in Winston-Salem to be consented and complete baseline questionnaires. They will be sent home with a hot flash diary to complete for two weeks in order to confirm a sufficient number of hot flashes for study eligibility. After two weeks, women will mail back their diaries and continue to record their daily hot flashes until they are notified by study staff of their eligibility, within a week of receiving the diary. If they qualify, a cooling mattress pad will be provided by study staff to be used for the duration of the intervention phase for approximately 8 weeks. The study staff will determine the efficacy of the cooling mattress pad through comparing answers to subject questionnaires at baseline and follow up in addition to comparing the baseline diaries to the intervention diaries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 24 peri or postmenopausal women aged 45-60 experiencing at least 4 hot flashes/night sweats/day will use a cooling mattress pad nightly for approximately 8 weeks
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing the Experience of Menopausal Symptoms Through Temperature (REST)
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: Experimental Cooling Mattress Pad
Subjects will use a cooling mattress pad nightly for approximately 8 weeks
Device: Cooling mattress pad
The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.




Primary Outcome Measures :
  1. Hot flash diary [ Time Frame: daily for 11 weeks ]
    Daily diary in which subjects will record the number of daily hot flashes and/or night sweats


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline ]
    Questionnaire that assesses the subjects' quality of sleep through their answers to 19 questions on sleep quality. The global score ranges from 0 to 16 with a score >5 indicating poor sleep quality.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: follow up at 11 weeks ]
    Questionnaire that assesses the subjects' quality of sleep through their answers to 19 questions on sleep quality. The global score ranges from 0 to 16 with a score >5 indicating poor sleep quality


Other Outcome Measures:
  1. Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: baseline ]
    Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

  2. Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: follow up at 11 weeks ]
    Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

  3. Center for Epidemiologic Studies Depression Scale (CESD-10) [ Time Frame: baseline ]
    Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

  4. Center for Epidemiologic Studies Depression Scale (CESD-10) [ Time Frame: follow up at 11 weeks ]
    Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

  5. Health Related Quality of Life (HRQL) [ Time Frame: baseline ]
    Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

  6. Health Related Quality of Life (HRQL) [ Time Frame: follow up at 11 weeks ]
    Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

  7. Somatosensory Amplification Scale (SSAS) [ Time Frame: baseline ]
    Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.

  8. Health Behaviors Questionnaire [ Time Frame: baseline ]
    Questionnaire that allows the study team to record baseline behaviors

  9. Evaluation of Intervention [ Time Frame: follow up at 11 weeks ]
    Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 45-60
  • Peri or postmenopausal women (No periods for at least 3 months)
  • Experiencing at least 4 hot flashes per day on average per week

Exclusion Criteria:

  • Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks.
  • Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
  • Initiated antidepressants in the last 3 months.
  • Changed their dose of an antidepressant in the last 3 months.
  • Women who describe their health as fair or poor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937466


Locations
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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Nancy E Avis, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03937466    
Other Study ID Numbers: IRB00057388
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wake Forest University Health Sciences:
hot flashes
menopause
cooling mattress pad
Additional relevant MeSH terms:
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Hot Flashes
Signs and Symptoms