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Completed

NCT Number: NCT03937466

Reducing the Experience of Menopausal Symptoms Through Temperature

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.

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Key information

Conditions

Hot Flashes Menopause Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cooling mattress pad

Device

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.

Primary outcomes

  1. Hot Flash Diary

    Time frame: baseline

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

  2. Hot Flash Diary

    Time frame: Week 10

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

  3. Hot Flash Severity Index Score

    Time frame: baseline

    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.

  4. Hot Flash Severity Index Score

    Time frame: Week 10

    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.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

    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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Week 10

    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

Other outcomes

  1. Hot Flash Related Daily Interference Scale (HFRDIS)

    Time frame: baseline

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

  2. Hot Flash Related Daily Interference Scale (HFRDIS)

    Time frame: follow up at 11 weeks

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

  3. Center for Epidemiologic Studies Depression Scale (CESD-10)

    Time frame: baseline

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

  4. Center for Epidemiologic Studies Depression Scale (CESD-10)

    Time frame: follow up at 11 weeks

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

  5. Health Related Quality of Life (HRQL)

    Time frame: baseline

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

  6. Health Related Quality of Life (HRQL)

    Time frame: follow up at 11 weeks

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

  7. Somatosensory Amplification Scale (SSAS)

    Time frame: baseline

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

  8. General Anxiety Disorder (GAD-7)

    Time frame: baseline and week 11

    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.

  9. Health Behaviors Questionnaire

    Time frame: baseline

    Questionnaire that allows the study team to record baseline behaviors

  10. Evaluation of Intervention

    Time frame: follow up at 11 weeks

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Reducing the Experience of Menopausal Symptoms Through Temperature (REST)

Acronym: REST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 3, 2019
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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