Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Experimental | Subjects will use a cooling mattress pad nightly for approximately 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pittsburgh Sleep Quality Index (PSQI) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hot Flash Related Daily Interference Scale (HFRDIS) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy E Avis, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Cooling Mattress Pad | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population data includes only the participants who completed the study and who are included at baseline time frame in outcomes.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Cooling Mattress Pad | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | number of hot flashes per week | baseline |
|
|
From baseline through week 10.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Cooling Mattress Pad | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Avis, PhD | Wake Forest University School of Medicine | 336-716-6974 | navis@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2020 | May 27, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2021 | Dec 17, 2021 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Somatosensory Amplification Scale (SSAS) | Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better. | baseline |
| 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 |
| Health Behaviors Questionnaire | Questionnaire that allows the study team to record baseline behaviors | baseline |
| 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 |
| 3 did not complete follow-up questionnaire. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | 4 participants did not fill out hot flash diary at week 10 | Posted | Mean | Standard Deviation | number of hot flashes per week | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 4 did not fill out hot flash diaries at week 10 | Posted | Mean | Standard Deviation | score on a scale | 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. | 1 person did not answer all PSQI items at baseline, so data not included here. | Posted | Mean | Standard Deviation | score on a scale | 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 | Posted | Mean | Standard Deviation | score on a scale | Week 10 |
|
|
|
| Other Pre-specified | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | 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. | Not Posted | follow up at 11 weeks | Participants |
| Other Pre-specified | 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. | Not Posted | baseline | Participants |
| Other Pre-specified | 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. | Not Posted | follow up at 11 weeks | Participants |
| Other Pre-specified | Health Related Quality of Life (HRQL) | Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better. | Not Posted | baseline | Participants |
| Other Pre-specified | Health Related Quality of Life (HRQL) | Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better. | Not Posted | follow up at 11 weeks | Participants |
| Other Pre-specified | Somatosensory Amplification Scale (SSAS) | Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better. | Not Posted | baseline | Participants |
| Other Pre-specified | 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. | Not Posted | baseline and week 11 | Participants |
| Other Pre-specified | Health Behaviors Questionnaire | Questionnaire that allows the study team to record baseline behaviors | Not Posted | baseline | Participants |
| Other Pre-specified | Evaluation of Intervention | Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked. | Not Posted | follow up at 11 weeks | Participants |
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
Not provided
Not provided
Not provided