REST: Reducing the Experience of Menopausal Symptoms Through Temperature

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03937466
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.2
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hot Flashes; Menopause	Device: Cooling mattress pad	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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 weeks24 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reducing the Experience of Menopausal Symptoms Through Temperature (REST)
• Actual Study Start Date: Jul 30, 2019
• Actual Primary Completion Date: Jun 4, 2021
• Actual Study Completion Date: Jun 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Cooling Mattress Pad Subjects will use a cooling mattress pad nightly for approximately 8 weeks	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.

Outcome Measures

Primary Outcome Measures

1. Hot Flash Diary [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 [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 [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 [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 Outcome Measures

1. Pittsburgh Sleep Quality Index (PSQI) [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) [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 Outcome Measures

1. Hot Flash Related Daily Interference Scale (HFRDIS) [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) [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) [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) [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) [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) [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) [baseline]

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

8. General Anxiety Disorder (GAD-7) [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 [baseline]

   Questionnaire that allows the study team to record baseline behaviors

10. Evaluation of Intervention [follow up at 11 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Nancy E Avis, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 22, 2020
• Informed Consent Form - Mar 31, 2021

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03937466
• Other Study ID Numbers: IRB00057388
• First Posted: May 3, 2019
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Wake Forest University Health Sciences: hot flashes; menopause; cooling mattress pad
• Additional relevant MeSH terms: Hot Flashes

Study Results

Participant Flow

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Period Title: Overall Study
STARTED	38
COMPLETED	15
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Overall Participants	15
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.2 (3.9)
Sex: Female, Male (Count of Participants)
Female	15 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.7%
Not Hispanic or Latino	14 93.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 6.7%
White	14 93.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%

Outcome Measures

1. Primary Outcome

Title	Hot Flash Diary
Description	Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	15
Mean (Standard Deviation) [number of hot flashes per week]	9 (4.5)

2. Primary Outcome

Title	Hot Flash Diary
Description	Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

4 participants did not fill out hot flash diary at week 10

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	11
Mean (Standard Deviation) [number of hot flashes per week]	4.5 (3.0)

3. Primary Outcome

Title	Hot Flash Severity Index Score
Description	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.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	15
Mean (Standard Deviation) [score on a scale]	20.0 (10.4)

4. Primary Outcome

Title	Hot Flash Severity Index Score
Description	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.
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

4 did not fill out hot flash diaries at week 10

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	11
Mean (Standard Deviation) [score on a scale]	7.8 (6.4)

5. Secondary Outcome

Title	Pittsburgh Sleep Quality Index (PSQI)
Description	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.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

1 person did not answer all PSQI items at baseline, so data not included here.

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	14
Mean (Standard Deviation) [score on a scale]	11.14 (3.16)

6. Secondary Outcome

Title	Pittsburgh Sleep Quality Index (PSQI)
Description	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
Time Frame	Week 10

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
Measure Participants	15
Mean (Standard Deviation) [score on a scale]	7.87 (3.50)

7. Other Pre-specified Outcome

Title	Hot Flash Related Daily Interference Scale (HFRDIS)
Description	Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Hot Flash Related Daily Interference Scale (HFRDIS)
Description	Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.
Time Frame	follow up at 11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Center for Epidemiologic Studies Depression Scale (CESD-10)
Description	Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Center for Epidemiologic Studies Depression Scale (CESD-10)
Description	Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.
Time Frame	follow up at 11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	Health Related Quality of Life (HRQL)
Description	Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Other Pre-specified Outcome

Title	Health Related Quality of Life (HRQL)
Description	Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.
Time Frame	follow up at 11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Other Pre-specified Outcome

Title	Somatosensory Amplification Scale (SSAS)
Description	Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Other Pre-specified Outcome

Title	General Anxiety Disorder (GAD-7)
Description	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.
Time Frame	baseline and week 11

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Other Pre-specified Outcome

Title	Health Behaviors Questionnaire
Description	Questionnaire that allows the study team to record baseline behaviors
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Other Pre-specified Outcome

Title	Evaluation of Intervention
Description	Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.
Time Frame	follow up at 11 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From baseline through week 10.
Arm/Group Title	Experimental Cooling Mattress Pad
Arm/Group Description	Subjects will use a cooling mattress pad nightly for approximately 8 weeks 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.
All Cause Mortality
	Experimental Cooling Mattress Pad
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Serious Adverse Events
	Experimental Cooling Mattress Pad
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Cooling Mattress Pad
	Affected / at Risk (%)	# Events
Total	0/38 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.