Clinical trial NCT03937466: Reducing the Experience of Menopausal Symptoms Through Temperature
Official title: Reducing the Experience of Menopausal Symptoms Through Temperature (REST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Menopause
Keywords: hot flashes
menopause
cooling mattress pad
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 38
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Hot Flash Diary
timeFrame: baseline
measure: Hot Flash Diary
timeFrame: Week 10
measure: Hot Flash Severity Index Score
timeFrame: baseline
measure: Hot Flash Severity Index Score
timeFrame: Week 10
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 10
Other outcomes:
measure: Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: baseline
measure: Hot Flash Related Daily Interference Scale (HFRDIS)
timeFrame: follow up at 11 weeks
measure: Center for Epidemiologic Studies Depression Scale (CESD-10)
timeFrame: baseline
measure: Center for Epidemiologic Studies Depression Scale (CESD-10)
timeFrame: follow up at 11 weeks
measure: Health Related Quality of Life (HRQL)
timeFrame: baseline
measure: Health Related Quality of Life (HRQL)
timeFrame: follow up at 11 weeks
measure: Somatosensory Amplification Scale (SSAS)
timeFrame: baseline
measure: General Anxiety Disorder (GAD-7)
timeFrame: baseline and week 11
measure: Health Behaviors Questionnaire
timeFrame: baseline
measure: Evaluation of Intervention
timeFrame: follow up at 11 weeks
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Nancy E Avis, PhD
role: PRINCIPAL_INVESTIGATOR
References: