Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
Study NCT ID:
NCT04131868
Status:
COMPLETED
Last Update Posted:
2019-11-05
First Post:
2019-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep and Girls' Emotions Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': '1 week', 'description': 'Center for Epidemiological Studies Depression Scale score. The CESD-R is a 20-item measure of the frequency of depressive symptoms, with each item rated on a scale from 0 (not at all or less than one day) to 5 (nearly every day). Total scores range from 0 to 100, with higher scores indicating greater number and frequency of depressive symptoms.'}, {'measure': 'Reward-related brain function', 'timeFrame': '1 week', 'description': 'BOLD fMRI response during Reward Guessing Task'}, {'measure': 'Sleep duration', 'timeFrame': '1 week', 'description': 'Mean actigraphy-measured sleep duration'}], 'secondaryOutcomes': [{'measure': 'Positive affect', 'timeFrame': '1 week', 'description': 'International Positive and Negative Affect Scale Short Form - Positive Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each positive adjective are summed to produce a Positive Affect (PA) score ranging from 5 to 25, with higher scores indicating more positive affect.'}, {'measure': 'Negative affect', 'timeFrame': '1 week', 'description': 'International Positive and Negative Affect Scale Short Form - Negative Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each negative adjective are summed to produce a Negative Affect (PA) score ranging from 5 to 25, with higher scores indicating more negative affect.'}, {'measure': 'Reward effort', 'timeFrame': '1 week', 'description': 'Effort Expenditure for Rewards Task score'}, {'measure': 'Reward-related functional connectivity', 'timeFrame': '1 week', 'description': 'BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '22 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant eligibility is based on self-representation of gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insufficient sleep (total sleep time \\< 8 hours per night, with sleepiness scores ≥ 6 on the Epworth Sleepiness Scale OR ≥ 16 on the PROMIS Sleep Related Impairment Scale)\n* Symptoms of depression (≥ 15 on the Center for Epidemiological Studies for Depression Scale)\n\nExclusion Criteria:\n\n* Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder\n* History of head injury with loss of consciousness within the past two years\n* History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome\n* Neurological disorder\n* Use of psychiatric medications\n* Current psychotic symptoms\n* Active suicidal ideation\n* Conditions that are contraindicated for MRI (e.g., ferromagnetic material in the body)\n* Meet criteria for current substance use disorder with greater than mild severity'}, 'identificationModule': {'nctId': 'NCT04131868', 'acronym': 'SAGE', 'briefTitle': "Sleep and Girls' Emotions Study", 'organization': {'class': 'OTHER', 'fullName': 'University of Oregon'}, 'officialTitle': 'The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls', 'orgStudyIdInfo': {'id': 'K01MH103511', 'link': 'https://reporter.nih.gov/quickSearch/K01MH103511', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended sleep opportunity', 'interventionNames': ['Behavioral: Extended sleep opportunity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Typical sleep opportunity', 'interventionNames': ['Behavioral: Typical sleep opportunity']}], 'interventions': [{'name': 'Typical sleep opportunity', 'type': 'BEHAVIORAL', 'description': 'Typical sleep opportunity with consistent sleep timing for 1 week', 'armGroupLabels': ['Typical sleep opportunity']}, {'name': 'Extended sleep opportunity', 'type': 'BEHAVIORAL', 'description': 'Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week', 'armGroupLabels': ['Extended sleep opportunity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'University of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Melynda D Casement, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oregon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oregon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melynda Casement', 'investigatorAffiliation': 'University of Oregon'}}}}