Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

Wake Forest University (WFU)

Status: Completed

Conditions: Menopause; Hot Flashes

Treatments: Device: Cooling mattress pad

Study type: Interventional

Funder types: Other

Identifiers

NCT03937466

IRB00057388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Experimental Cooling Mattress Pad

Experimental group

Description:

Subjects will use a cooling mattress pad nightly for approximately 8 weeks

Treatment:

Device: Cooling mattress pad