Optimized Sleep After Brain Injury: Sleep Hygiene Intervention After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

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.
    

Detailed description: 
      Estimates of sleep disruption after traumatic brain injury (TBI) reach 81%, but the incidence
      nature, course and effect on recovery from TBI are not well understood because most TBI sleep
      studies included mixed TBI severity samples at varied times post injury. In the early
      rehabilitation phase of recovery from moderate-to-severe TBI, sleep disturbance has been
      estimated at 78% and has been associated with the presence of post-traumatic amnesia (PTA); a
      transient period of disorientation, confusion and inability to store memories that occurs
      after TBI. Individuals with TBI who are in PTA not only have severe memory dysfunction that
      significantly impairs their ability to benefit from verbal instruction, but are often in a
      confusional state with agitated behavior. They require a 24-hour, highly structured
      environment for safety until their PTA resolves. PTA can last from days to weeks, during
      which time the individual and his/her family are significantly distressed. Its duration also
      has practical implications in terms of resources, length of hospitalization and cost.

      There appears to be a relationship between sleep disturbance and PTA during early recovery
      from TBI, but the nature of the relationship is not fully understood. Sleep disturbance has
      been associated with delirium in non-TBI medical patients, and sleep deprivation has been
      associated with significant negative effects on attention, reaction time, visual-motor
      performance, language functions, memory processes, and executive functions in normal
      populations. Sleep disturbance appears to negatively affect cognitive functioning in both
      medical and normal samples. In the TBI population, sleep disruption could further exacerbate
      the already compromised cognitive functions and prolong PTA. The relationship between sleep
      disruption and PTA presents a potentially significant therapeutic opportunity because PTA is
      largely considered to be fixed and immutable with no therapeutic options. Therapeutic efforts
      to improve sleep may reduce the length of PTA.

      The proposed study will begin to address the gap in knowledge about the nature, incidence and
      effect of sleep disturbances on recovery from moderate-to-severe TBI during the early
      rehabilitation period. It will also pilot a sleep hygiene protocol to improve sleep for
      individuals in the early rehabilitation phase after TBI. It will employ 24-hour per day sleep
      observations and actigraphy to characterize the incidence and type of sleep disturbances in
      the early rehabilitation phase of TBI. In addition, the study will serially test participants
      multiple times a week with the Orientation Log (OLOG) and the Confusion Assessment Protocol
      (CAP) to closely monitor changes in alertness, orientation, attention, memory functions and
      behavior as they emerge from PTA. The sleep observations and actigraph information can then
      be compared to the cognitive measures of PTA to examine the relationship of sleep quantity
      and quality on cognitive functions during recovery from PTA.

      The randomized controlled trial with minimization allocation (RCT) pilot component of the
      study will be the first therapeutic attempt that we are aware of; to normalize sleep cycles
      and sleep quality in individuals with TBI who have sleep disruptions during early
      rehabilitation. Twenty individuals with TBI who have low sleep efficiency on actigraphy
      during the initial night time screening will be randomized into a comprehensive sleep hygiene
      protocol (SHP = 10) or a standard of care (SOC = 10) protocol for three weeks. Both groups
      will have access to all rehabilitation facilities, therapies, services and programs. The
      difference between the groups is the systematic attempt to improve sleep in the SHP by five
      principle components: 1) improved night sleep environment, 2) increased daytime activation,
      3) enhanced circadian stimuli, 4) morning ADL routines individually adjusted to pre-injury
      biological sleep patterns and 5) no caffeine intake. In the SOC group, there will be no
      systematic efforts to influence circadian rhythms, daytime activation or nighttime sleep
      environment. Participant's sleep in both groups will be monitored with 24-hour actigraphy and
      staff ratings of sleep-awake periods throughout the 24 hour period on the Makley Sleep Scale
      (MSS) for four weeks. Additionally, nursing staff will rate agitation on the Agitated
      Behavior Scale and therapy staff will monitor cognitive functioning with the Orientation Log
      (OLOG) and Confusion Assessment Protocol (CAP) until after emergence from PTA. The sleep
      data, cognitive testing and behavioral information for both groups will enable examination of
      the relationship of sleep to PTA and the potential benefit of the SHP on normalizing sleep
      and enhancing cognitive recovery, including resolution of PTA.
    

Intervention name(s): Sleep Hygiene Protocol; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: traumatic brain injury; sleep-wake cycle disturbance; circadian disruption