Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-04-08 @ 2:14 PM
Study NCT ID:
NCT00860756
Status:
UNKNOWN
Last Update Posted:
2009-03-12
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disturbance in Deployed Soldiers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-11', 'studyFirstSubmitDate': '2009-03-10', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actigraph and self report questionnaires', 'timeFrame': 'baseline, 6 months, 18 months'}], 'secondaryOutcomes': [{'measure': 'Self report questionnaires', 'timeFrame': 'baseline, 6 months, 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep', 'disturbance', 'deployment', 'intervention', 'actigraph'], 'conditions': ['Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'Hypotheses:\n\n* Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.\n* Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention group will more closely approximate normal as compared to sleep measures of Soldiers randomized to the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All study participants must be on Active Duty, or be Reserve or National Guard Service Members notified of impending deployment.\n* Recruited prior to deployment in order to obtain baseline measures before deployment.\n* Have been stateside at least one full year.\n* Able to read and speak English and consent themselves.\n\nExclusion Criteria:\n\n* Subjects with self-identified sleep disorder (for example restless leg syndrome or sleep apnea)\n* Pregnancy. Pregnant women will be excluded from the study since pregnancy places women in a non-deployable status and pregnant Soldiers will not be deploying.'}, 'identificationModule': {'nctId': 'NCT00860756', 'briefTitle': 'Sleep Disturbance in Deployed Soldiers', 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'Sleep Disturbance in Deployed Soldiers', 'orgStudyIdInfo': {'id': 'I2007.242dt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Intervention Group', 'interventionNames': ['Other: Relaxation CD']}], 'interventions': [{'name': 'Relaxation CD', 'type': 'OTHER', 'description': 'A music CD specifically created for this study to promote effective sleep while deployed. It includes sleep instructions tailored to the military deployment environment. The CD includes a voice directed meditation component that helps focus the listener on relaxation in preparation for sleep. The second track is specifically designed music to promote slow breathing and induce sleep.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80913', 'city': 'Fort Carson', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mona O. Bingham, PhD', 'role': 'CONTACT', 'email': 'mona.bingham@amedd.army.mil', 'phone': '210-916-7159'}], 'facility': 'Evans Army Community Hospital', 'geoPoint': {'lat': 38.73749, 'lon': -104.78886}}, {'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Carl R. Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mona O. Bingham, PhD', 'role': 'CONTACT', 'email': 'mona.bingham@amedd.army.mil', 'phone': '210-916-7159'}, {'name': 'Stacey Young-McCaughan, PhD', 'role': 'CONTACT', 'email': 'stacey.young-mccaughan@us.army.mil', 'phone': '(210) 567-1942'}, {'name': 'Mona O Bingham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}], 'centralContacts': [{'name': 'Mona O. Bingham, PhD', 'role': 'CONTACT', 'email': 'mona.bingham@amedd.army.mil', 'phone': '(210) 916-7159'}, {'name': 'Stacey Young-McCaughan, PhD', 'role': 'CONTACT', 'email': 'stacey.young-mccaughan@us.army.mil', 'phone': '(210) 567-1942'}], 'overallOfficials': [{'name': 'Mona O. Bingham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LTC, Chief Nursing Research Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'LTC Mona O. Bingham, PhD, RN; Chief, Nursing Research', 'oldOrganization': 'Brooke Army Medical Center'}}}}