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

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Estimated length of stay < 4 weeks

- Medical Proxy unavailable to consent