Reducing the Experience of Menopausal Symptoms Through Temperature

Menopause Clinical Trial

— REST  

Official title:

Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937466
• Other study ID #: IRB00057388
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: June 4, 2021

Study information

• Verified date: June 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Somatosensory Amplification Scale (SSAS)	Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.	baseline
Other	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
Other	Health Behaviors Questionnaire	Questionnaire that allows the study team to record baseline behaviors	baseline
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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