Optimized Sleep After Brain Injury: Sleep Hygiene Intervention After Traumatic Brain Injury
OSABI
1 other identifier
interventional
22
1 country
1
Brief Summary
OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI during inpatient rehabilitation. Twenty participants will be allocated (by minimization) either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the trial period to examine relationships among them.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedAugust 2, 2018
July 1, 2018
2.2 years
June 24, 2016
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actiwatch Sleep Efficiency
Sleep efficiency via actigraphy is recorded nightly for 4 weeks
4 weeks
Secondary Outcomes (4)
Agitated Behavior Scale
4 weeks
Makley Sleep Scale
4 weeks
Orientation Log (O-Log)
4 weeks
Confusion Assessment Protocol (CAP)
4 weeks
Study Arms (2)
Sleep Hygiene Protocol
EXPERIMENTALParticipants in this arm will undergo a 4 week sleep hygiene protocol
Standard of Care Protocol
ACTIVE COMPARATORParticipants will undergo 4 weeks of current inpatient standard of care procedures in a rehabilitation facility
Interventions
Sleep Hygiene Protocol involving 1) Improved sleep environment 2) Enhanced Circadian Stimuli 3) Increased Daytime Activation (blue light therapy, daytime light exposure and daytime sleep restriction) 4) Adjusted morning ADL routines and 5) Restricted Caffeine intake
All standard of care procedures in a specialized traumatic brain injury inpatient rehabilitation unit
Eligibility Criteria
You may qualify if:
- All male inpatient admissions to Craig Hospital with the primary diagnosis of TBI
- Rancho Level of Cognitive Functioning Scale \>= III
- Ages \>= 18 and \< =55
- Fluent in the English language
- Available upper extremity for actigraph placement
- Average sleep efficiency= \< 75 for three consecutive nights as measured by clinical actigraphy
- Physician judgment that the individual is in post-traumatic amnesia
You may not qualify if:
- Medical conditions that require intensive nursing care during the night time sleep period as determined by physician, e.g. tracheostomy
- Hydrocephalus with V-P shunt
- Penetrating Head Injury
- Anoxia associated with TBI
- Stroke associated with TBI
- Spinal cord injury associated with TBI
- Halo Fixation for cervical spine fracture
- Greater than 90 days post injury on admission to Craig Hospital
- Out of Post Traumatic Amnesia on screening
- Severe agitation that would make participation in the study unsafe as determined by the attending physician
- Unable to complete verbal assessments
- History of previous TBI requiring hospitalization
- History of neurodegenerative disease or dementing illness
- History of pre-existing diabetes, pre-disposing factors for diabetes
- History of retinal disease
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Craig Hospitallead
- Colorado Traumatic Brain Injury Trust Fundcollaborator
Study Sites (1)
Craig Hospital
Englewood, Colorado, 80113, United States
Related Publications (2)
Makley MJ, Gerber D, Newman JK, Philippus A, Monden KR, Biggs J, Spier E, Tarwater P, Weintraub A. Optimized Sleep After Brain Injury (OSABI): A Pilot Study of a Sleep Hygiene Intervention for Individuals With Moderate to Severe Traumatic Brain Injury. Neurorehabil Neural Repair. 2020 Feb;34(2):111-121. doi: 10.1177/1545968319895478. Epub 2019 Dec 30.
PMID: 31884895DERIVEDDraganich C, Gerber D, Monden KR, Newman J, Weintraub A, Biggs J, Philippus A, Makley M. Disrupted sleep predicts next day agitation following moderate to severe brain injury. Brain Inj. 2019;33(9):1194-1199. doi: 10.1080/02699052.2019.1631484. Epub 2019 Jun 19.
PMID: 31215813DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2016
First Posted
July 20, 2016
Study Start
August 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
August 2, 2018
Record last verified: 2018-07