Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT02068703
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Enhancing Tools: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of sleep enhancing tools on medication use', 'timeFrame': 'baseline to day 3', 'description': 'Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced use of sleep or pain medication'}, {'measure': 'Effect of sleep enhancing tools on participation in Occupational therapy', 'timeFrame': 'baseline to day 3', 'description': 'Whether the intervention of using sleep enhancing tools will translate into increased number of days participating in therapy during the study'}], 'primaryOutcomes': [{'measure': 'Aggregate change in sleep /pain / fatigue scores on Patient Reported Outcomes Measurement Information System (PROMIS) survey sampled in hospital from baseline to day 3 between study groups', 'timeFrame': 'Baseline to day 3', 'description': 'Change from baseline in sleep / pain / fatigue scores on PROMIS survey in the hospital. Each score ranges from 1-5, 1 equals not at all; 5 equals Very much.'}], 'secondaryOutcomes': [{'measure': 'Effect of use of sleep tool devices on length of stay', 'timeFrame': 'number hospital days between administration of tool and hospital discharge', 'description': 'Whether the intervention of demonstrating use of sleep enhancing tools will translate into reduced length of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['survey'], 'conditions': ['Sleep', 'Pain']}, 'descriptionModule': {'briefSummary': 'To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise machine) in hospitalized patients can positively affect subjective symptoms of sleep quality, fatigue and pain.', 'detailedDescription': "A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.\n\nWe propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.\n\nThe primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).\n\nPROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.\n\nInformation on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.\n\nOur study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to a private room in the hospital\n* Speak and read english\n* expected length of stay \\> 2 days\n\nExclusion Criteria:\n\n* Hearing aids\n* sleep apnea using positive airway pressure therapy\n* medically or behaviorally unstable'}, 'identificationModule': {'nctId': 'NCT02068703', 'briefTitle': 'Sleep Enhancing Tools: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Use of Sleep Enhancing Tools Impact on Self-Reported Sleep Survey', 'orgStudyIdInfo': {'id': 'HUM00075628'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools (face mask, ear plugs and white noise machine) to improve sleep.', 'interventionNames': ['Behavioral: Sleep Education Presentation', 'Behavioral: Sleep Tool Demonstration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inert Control', 'description': 'Same 10 min time exposure and tool delivery to subjects in this arm WITHOUT demonstration.', 'interventionNames': ['Behavioral: Sleep Education Presentation']}], 'interventions': [{'name': 'Sleep Education Presentation', 'type': 'BEHAVIORAL', 'description': 'Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.', 'armGroupLabels': ['Inert Control', 'Intervention']}, {'name': 'Sleep Tool Demonstration', 'type': 'BEHAVIORAL', 'description': 'Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'UMichigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Peter Farrehi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Peter Farrehi MD', 'investigatorAffiliation': 'University of Michigan'}}}}