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.

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.

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

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.

Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.

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.

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.

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.

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

Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.

Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.

Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.

Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.

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.

Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.

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.