Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT05483920
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2022-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070263', 'term': 'Sleep Hygiene'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ashley.pfeiffer@bhsu.edu', 'phone': '(605) 381-5370', 'title': 'Dr. Ashley Pfeiffer', 'organization': 'Black Hills State University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations of the study include a small sample size, and minimal heterogeneity of gender, and race. We were limited to one geographical region.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored for the one-month of the study however no adverse events were reported.', 'description': 'The number of participants at risk for serious adverse events, all-cause mortality, and other is zero due to a minimal risk activity of filling out surveys and wearing a sleep tracker.', 'eventGroups': [{'id': 'EG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '7'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Change score average'}, {'type': 'PRIMARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '16'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Average change scores'}, {'type': 'PRIMARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Average change score'}, {'type': 'PRIMARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-4', 'upperLimit': '8'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'average change score on ESS'}, {'type': 'PRIMARY', 'title': "Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.34', 'groupId': 'OG000', 'lowerLimit': '-8.5', 'upperLimit': '2.5'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 4-week follow up', 'description': 'Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score.', 'unitOfMeasure': 'percentage points of efficiency', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '13'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-1.67', 'upperLimit': '4.67'}, {'value': '0.16', 'groupId': 'OG001', 'lowerLimit': '-4.66', 'upperLimit': '3.67'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'OG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.001', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '1.5'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '1.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 4-week follow up', 'description': 'Body mass index is measured by body weight \\[kg\\]/ height \\[m\\]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight.', 'unitOfMeasure': 'kg/m^2 (kilograms/meters squared)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'FG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'One-time Educational Video', 'description': 'A one-time educational video on best practices for good sleep hygiene\n\nOne-time educational video: One-time educational video'}, {'id': 'BG001', 'title': 'One-time Educational Video Plus Automated Text Messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.\n\nOne-time educational video plus automated text messaging: Educational video plus automated text messaging'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sleep Hygiene Index', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '15'}, {'value': '8.7', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '7.7', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'description': 'sleep quality measurement. Scores range 0-21 with higher scores indicating poorer sleep quality. Collected through an electronic survey.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-01', 'size': 420150, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-12T11:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two arms of the study including intervention and a control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2022-07-29', 'resultsFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-14', 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Score From Baseline to 4-week Follow up on the Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for quality of sleep. Score ranges 0-21 with higher score equaling poor sleep quality'}, {'measure': 'Change Score From Baseline to 4-week Follow up on the Sleep Hygiene Index', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for good sleep hygiene. Scores range from 0-52. Higher scores equate to worse sleep hygiene.'}, {'measure': 'Change Score From Baseline to 4-week Follow up on the Numeric Pain Rating Scale', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average pain levels. Scores range from 0-10. Higher scores equate to higher pain levels.'}, {'measure': 'Change Score From Baseline to 4-week Follow up on the Epworth Sleepiness Scale', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average daytime sleepiness. Scores range from 0-24. Higher scores equate to worse daytime sleepiness.'}, {'measure': "Change Score From Baseline to 4-weeks for Participants' Sleep Efficiency Using Wearable Technology.", 'timeFrame': 'Baseline, 4-week follow up', 'description': 'Sleep efficiency scores will be calculated using a sleep tracker device and are defined as time spent in bed versus time spent actually sleeping. 85% or higher is considered normal sleep efficiency. The average sleep efficiency score for the first three days at baseline and average sleep efficiency from the last 3 days of the 4 week study period will be used to gather the change score.'}], 'secondaryOutcomes': [{'measure': 'Change Score From Baseline to 4-week Follow up on the Perceived Stress Scale', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for average stress levels. Scores range from 0-40. The higher the score the worse the stress levels.'}, {'measure': 'Change Score From Baseline to 4-week Follow up on the Patient Specific Functional Scale', 'timeFrame': 'Baseline and 4-week follow up', 'description': 'Outcome measure for overall function. The participant chooses three functional day-to-day activities that they regularly participate in and they rate those activities from 0-10 on ease or difficulty of completing. 0 indicates unable to perform the activity, and 10 indicates no problem with the activity. The total score is calculated by adding all three activity scores and dividing by the number of activities listed for a total score ranging from 0-10.'}, {'measure': "Change Scores From Baseline to 4-week Follow up for Participant's Body Mass Index", 'timeFrame': 'baseline and 4-week follow up', 'description': 'Body mass index is measured by body weight \\[kg\\]/ height \\[m\\]2) from weight and height measurements to determine healthy body anthropometrics. Normal value is 18.5 to 24.9. Above these values is considered overweight and obese, under this is considered underweight.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Habit, Good', 'Sleep Hygiene', 'Health Behavior']}, 'descriptionModule': {'briefSummary': "This will be a study looking at trying to change community-dwelling older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.", 'detailedDescription': 'Community-dwelling older adults will be recruited and placed into one of two groups. Group one will watch a one-time educational video on sleep hygiene and group two will watch the video plus be sent daily automated text messages to reinforce the education learned in the video. The participants will receive the text messages for a total of 4 weeks. The control group will not receive any intervention during this time frame. Following the initial meeting, all participants will wear the sleep tracker on their wrists during the day and night for 4 weeks. The sleep tracker will monitor the physiological markers of sleep provided by wearable technology on sleep efficiency, time in bed, time actually sleeping, and time spent at each stage of sleep. At the end of the 4-week study period, the researchers will once again meet with each participant. The participant will complete the following questionnaires once again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult between the ages of 50 and 80 will be recruited for the study\n\nExclusion Criteria:\n\n* Anyone with a diagnosed sleep disorder such as insomnia or obstructive sleep apnea, and the inability to wear any sleep tracking device on their wrist.'}, 'identificationModule': {'nctId': 'NCT05483920', 'briefTitle': 'Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Black Hills State University'}, 'officialTitle': 'Effects of Sleep Hygiene Education on Sleep Health in Community-Dwelling Older Adults', 'orgStudyIdInfo': {'id': 'BlackHillsST'}, 'secondaryIdInfos': [{'id': 'P20GM103443', 'link': 'https://reporter.nih.gov/quickSearch/P20GM103443', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One-time educational video', 'description': 'A one-time educational video on best practices for good sleep hygiene', 'interventionNames': ['Behavioral: One-time educational video']}, {'type': 'EXPERIMENTAL', 'label': 'One-time educational video plus automated text messaging', 'description': 'A one-time educational video on best practices for sleep hygiene plus daily automated text messages to reinforce habit.', 'interventionNames': ['Behavioral: One-time educational video plus automated text messaging']}], 'interventions': [{'name': 'One-time educational video', 'type': 'BEHAVIORAL', 'description': 'One-time educational video', 'armGroupLabels': ['One-time educational video']}, {'name': 'One-time educational video plus automated text messaging', 'type': 'BEHAVIORAL', 'description': 'Educational video plus automated text messaging', 'armGroupLabels': ['One-time educational video plus automated text messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57799', 'city': 'Spearfish', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills State University', 'geoPoint': {'lat': 44.49082, 'lon': -103.85937}}], 'overallOfficials': [{'name': 'Ashley M Pfeiffer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Black Hills State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Black Hills State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ashley Pfeiffer', 'investigatorAffiliation': 'Black Hills State University'}}}}