Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

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.

Study Overview

• Status: Completed
• Conditions: Hot Flashes; Menopause
• Intervention / Treatment: Device: Cooling mattress pad

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 either come to the Research Center in Winston-Salem to be consented and complete baseline questionnaires or complete these by mail or email. 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot Flash Diary	Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.	baseline
Hot Flash Diary	Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.	Week 10
Hot Flash Severity Index Score	The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.	baseline
Hot Flash Severity Index Score	The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.	Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	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.	baseline
Pittsburgh Sleep Quality Index (PSQI)	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	Week 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hot Flash Related Daily Interference Scale (HFRDIS)	Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.	baseline
Hot Flash Related Daily Interference Scale (HFRDIS)	Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.	follow up at 11 weeks
Center for Epidemiologic Studies Depression Scale (CESD-10)	Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.	baseline
Center for Epidemiologic Studies Depression Scale (CESD-10)	Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.	follow up at 11 weeks
Health Related Quality of Life (HRQL)	Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.	baseline
Health Related Quality of Life (HRQL)	Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.	follow up at 11 weeks
Somatosensory Amplification Scale (SSAS)	Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.	baseline
General Anxiety Disorder (GAD-7)	Anxiety symptoms will be measured with the GAD-7, which consists of 7 items, each describing a common symptom of anxiety. The respondent rates how much he or she has been bothered by each symptom over the past two weeks on a 4-point scale ranging from 0 to 3. Higher scores indicate more anxiety.	baseline and week 11
Health Behaviors Questionnaire	Questionnaire that allows the study team to record baseline behaviors	baseline
Evaluation of Intervention	Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.	follow up at 11 weeks

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Nancy E Avis, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2019
• Primary Completion (ACTUAL): June 4, 2021
• Study Completion (ACTUAL): June 4, 2021

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: menopause; hot flashes; cooling mattress pad
• Additional Relevant MeSH Terms: Hot Flashes
• Other Study ID Numbers: IRB00057388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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