Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-06 @ 8:37 AM
Study NCT ID:
NCT03937466
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2019-05-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing the Experience of Menopausal Symptoms Through Temperature
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'navis@wakehealth.edu', 'phone': '336-716-6974', 'title': 'Nancy Avis, PhD', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline through week 10.', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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.", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hot Flash Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.', 'unitOfMeasure': 'number of hot flashes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hot Flash Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10', 'description': 'Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.', 'unitOfMeasure': 'number of hot flashes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants did not fill out hot flash diary at week 10'}, {'type': 'PRIMARY', 'title': 'Hot Flash Severity Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hot Flash Severity Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '6.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 did not fill out hot flash diaries at week 10'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '11.14', 'spread': '3.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', '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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 person did not answer all PSQI items at baseline, so data not included here.'}, {'type': 'SECONDARY', 'title': 'Pittsburgh Sleep Quality Index (PSQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'classes': [{'categories': [{'measurements': [{'value': '7.87', 'spread': '3.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10', '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", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'baseline', 'description': "Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'follow up at 11 weeks', 'description': "Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Center for Epidemiologic Studies Depression Scale (CESD-10)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Center for Epidemiologic Studies Depression Scale (CESD-10)', 'timeFrame': 'follow up at 11 weeks', 'description': 'Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'follow up at 11 weeks', 'description': 'Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Somatosensory Amplification Scale (SSAS)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'General Anxiety Disorder (GAD-7)', 'timeFrame': 'baseline and week 11', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health Behaviors Questionnaire', 'timeFrame': 'baseline', 'description': 'Questionnaire that allows the study team to record baseline behaviors', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Evaluation of Intervention', 'timeFrame': 'follow up at 11 weeks', 'description': "Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'not eligbile after the 2-week diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'never returned their diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'dropped out of study before getting Chilipad', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': '3 did not complete follow-up questionnaire.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Cooling Mattress Pad', 'description': "Subjects will use a cooling mattress pad nightly for approximately 8 weeks\n\nCooling 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."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population data includes only the participants who completed the study and who are included at baseline time frame in outcomes.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-22', 'size': 287720, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-27T14:45', 'hasProtocol': True}, {'date': '2021-03-31', 'size': 204583, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-12-17T13:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2019-05-01', 'resultsFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-27', 'studyFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'baseline', 'description': "Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better."}, {'measure': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'follow up at 11 weeks', 'description': "Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better."}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CESD-10)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CESD-10)', 'timeFrame': 'follow up at 11 weeks', 'description': 'Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.'}, {'measure': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.'}, {'measure': 'Health Related Quality of Life (HRQL)', 'timeFrame': 'follow up at 11 weeks', 'description': 'Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.'}, {'measure': 'Somatosensory Amplification Scale (SSAS)', 'timeFrame': 'baseline', 'description': 'Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.'}, {'measure': 'General Anxiety Disorder (GAD-7)', 'timeFrame': 'baseline and week 11', '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.'}, {'measure': 'Health Behaviors Questionnaire', 'timeFrame': 'baseline', 'description': 'Questionnaire that allows the study team to record baseline behaviors'}, {'measure': 'Evaluation of Intervention', 'timeFrame': 'follow up at 11 weeks', 'description': "Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked."}], 'primaryOutcomes': [{'measure': 'Hot Flash Diary', 'timeFrame': 'baseline', 'description': 'Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.'}, {'measure': 'Hot Flash Diary', 'timeFrame': 'Week 10', 'description': 'Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.'}, {'measure': 'Hot Flash Severity Index Score', 'timeFrame': 'baseline', '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.'}, {'measure': 'Hot Flash Severity Index Score', 'timeFrame': 'Week 10', '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.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline', '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."}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'Week 10', '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"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['hot flashes', 'menopause', 'cooling mattress pad'], 'conditions': ['Hot Flashes', 'Menopause']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 45-60\n* Peri or postmenopausal women (No periods for at least 3 months)\n* Experiencing at least 4 hot flashes per day on average per week\n\nExclusion Criteria:\n\n* Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks.\n* Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks\n* Initiated antidepressants in the last 3 months.\n* Changed their dose of an antidepressant in the last 3 months.\n* Women who describe their health as fair or poor.'}, 'identificationModule': {'nctId': 'NCT03937466', 'acronym': 'REST', 'briefTitle': 'Reducing the Experience of Menopausal Symptoms Through Temperature', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Reducing the Experience of Menopausal Symptoms Through Temperature (REST)', 'orgStudyIdInfo': {'id': 'IRB00057388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Cooling Mattress Pad', 'description': 'Subjects will use a cooling mattress pad nightly for approximately 8 weeks', 'interventionNames': ['Device: Cooling mattress pad']}], 'interventions': [{'name': 'Cooling mattress pad', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Experimental Cooling Mattress Pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Nancy E Avis, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}