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Traumatic Brain InjuryOSABINCT02838082

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

A study testing Sleep Hygiene Protocol in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men only
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Sleep Hygiene Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Aug 2015to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Craig Hospital

    Englewood, Colorado, 80113

Other trials in United States

About this study

Official title: Optimized Sleep After Brain Injury: A Pilot Study

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.

Read the 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.

Being tested
Sleep Hygiene Protocol, Standard of Care
Keywords
traumatic brain injury, sleep-wake cycle disturbance, circadian disruption
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep Hygiene ProtocolBehavioural

    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

  • Standard of CareBehavioural

    All standard of care procedures in a specialized traumatic brain injury inpatient rehabilitation unit

Study groups in NCT02838082
Study groupRoleWhat they receive
Sleep Hygiene ProtocolExperimentalParticipants in this arm will undergo a 4 week sleep hygiene protocol
Receives: Behavioral: Sleep Hygiene Protocol
Standard of Care ProtocolActive comparatorParticipants will undergo 4 weeks of current inpatient standard of care procedures in a rehabilitation facility
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Actiwatch Sleep Efficiency

    Sleep efficiency via actigraphy is recorded nightly for 4 weeks

    Measured: 4 weeks

Secondary outcomes (4)
  1. Agitated Behavior Scale

    Nursing staff ratings on the Agitated Behavior Scale each shift

    Measured: 4 weeks

  2. Makley Sleep Scale

    Staff observations/ratings of sleep every two hours

    Measured: 4 weeks

  3. Orientation Log (O-Log)

    Speech Pathology assessment of post traumatic amnesia with the O-Log 5 days per week

    Measured: 4 weeks

  4. Confusion Assessment Protocol (CAP)

    Neuropsychology Assessment of cognitive status with the CAP three days per week

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02838082
Sponsor's protocol ID
839979IRB
Acronym
OSABI
Status last verified
Jul 2018
First submitted
24 Jun 2016
Last updated
2 Aug 2018
Results posted
No

Publications

  • 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.

    PubMed 31884895
  • Draganich 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.

    PubMed 31215813

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Hygiene Protocol in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Actiwatch Sleep Efficiency (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02838082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.

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