Optimized Sleep After Brain Injury: Sleep Hygiene Intervention After Traumatic Brain Injury

Completed · Not applicable

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT02838082

Run by

Craig Hospital

People needed

22

Starts

2015-08-01

Expected to finish

2017-10-01

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.

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
• History of pre-existing diagnosis of Schizophrenia or Bi-Polar Disorder
• History of Active Major Depressive Illness prior to injury
• History of a diagnosed sleep disorder per family report or medical history
• History of Sleep Disordered Breathing such as sleep apnea as determined by history obtained from significant other/family member or medical history
• History of night shift work or of not being in a consistently standard sleep wake schedule during three months prior to TBI as determined by history obtained from significant other/family member or medical history.
• History of untreated/uncontrolled thyroid disease
• Individuals with epilepsy
• Individuals with central or peripheral blindness
• Body mass index greater than 30.
• Enrollment in a concurrent interventional clinical trial

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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