Reducing the Experience of Menopausal Symptoms Through Temperature

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

Conditions
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Hot Flashes, Menopause

Intervention / Treatment
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* Device: Cooling mattress pad


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Cooling Mattress Pad<br>Subjects will use a cooling mattress pad nightly for approximately 8 weeks | Device: Cooling mattress pad<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hot flashes, menopause, cooling mattress pad