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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Traumatic Brain Injury
- 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 group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Protocol | Experimental | Participants in this arm will undergo a 4 week sleep hygiene protocol Receives: Behavioral: Sleep Hygiene Protocol |
| Standard of Care Protocol | Active comparator | Participants 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.
Actiwatch Sleep Efficiency
Sleep efficiency via actigraphy is recorded nightly for 4 weeks
Measured: 4 weeks
Secondary outcomes (4)
Agitated Behavior Scale
Nursing staff ratings on the Agitated Behavior Scale each shift
Measured: 4 weeks
Makley Sleep Scale
Staff observations/ratings of sleep every two hours
Measured: 4 weeks
Orientation Log (O-Log)
Speech Pathology assessment of post traumatic amnesia with the O-Log 5 days per week
Measured: 4 weeks
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.
- First posted20 Jul 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund
- Responsible party
- Sponsor
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 31884895Draganich 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Sleep After Brain Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT02838082
- Acronym / sponsor ID
- OSABI / 839979IRB
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, sleep-wake cycle disturbance, circadian disruption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Collaborators
- Colorado Traumatic Brain Injury Trust Fund
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Protocol | Experimental | Behavioral: Sleep Hygiene ProtocolParticipants in this arm will undergo a 4 week sleep hygiene protocol |
| Standard of Care Protocol | Active comparator | Behavioral: Standard of CareParticipants will undergo 4 weeks of current inpatient standard of care procedures in a rehabilitation facility |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Hygiene ProtocolSleep 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 | Behavioural | Sleep Hygiene Protocol |
| Standard of CareAll standard of care procedures in a specialized traumatic brain injury inpatient rehabilitation unit | Behavioural | Standard of Care Protocol |
Primary outcome
Actiwatch Sleep Efficiency
Time frame: 4 weeks
Sleep efficiency via actigraphy is recorded nightly for 4 weeks
4 secondary outcomes
Agitated Behavior Scale
Time frame: 4 weeks
Makley Sleep Scale
Time frame: 4 weeks
Orientation Log (O-Log)
Time frame: 4 weeks
Confusion Assessment Protocol (CAP)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 31884895Makley 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.
- Derived from this study: PubMed 31215813Draganich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.