Concussion, MildNCT02374918
Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury
A study testing mTBI wavelength-1 bright light, mTBI wavelength-2 bright light and HC wavelength-1 bright light in people with Concussion, Mild and Post-Concussion Symptoms, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild, Post-Concussion Symptoms, Sleep Problems
- What is being tested?
- mTBI wavelength-1 bright light, mTBI wavelength-2 bright light and HC wavelength-1 bright light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 18 and 50.
- The primary language of the subjects must be English.
- Subjects have experienced a "concussion" or mTBI within the preceding 18 months, but no sooner that 4 weeks prior to their screening. The occurrence of a concussion or mTBI must be documented by a medical report or other professional witness documentation.
- If documented, Glasgow Coma Scale in the range of 13-15 following the injury.
- Subjects must have complaints of sleep difficulties that emerged or worsened following the most recent head injury.
- At least half of subjects must have evidence of sleep onset insomnia or delayed sleep phase disorder.
Who cannot join
- Any other history of neurological illness, current Diagnostic Statistical Manual (DSM-IV) Axis I disorder, lifetime history of psychotic disorder, or head injury with loss of consciousness > 30 minutes
- Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV, brain tumor, etc.)
- Abnormal visual acuity that is not corrected by contact lenses
- Metal within the body, claustrophobia, or other contraindications for neuroimaging
- Less than 9th grade education
- Excess current alcohol use (more than 2 instances of intake of 5+ drinks (men) when or 4+ drinks (women) when drinking in the past two months, and/or on average drinking > 2 drinks per day (men); > 1 drinks per day (women) during the past two months
Show all 10Show fewer
- History of alcoholism or substance use disorder
- Significant use of illicit drugs
- History of marijuana use within the past 6 weeks and/or use of marijuana before the age of 16.
- Subjects who engage in shift-work, night work, or who have substantially desynchronized work-sleep schedules (i.e., sleeping later than 10:00 a.m. more than once a week) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.
Read the detailed description
Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in the investigators society. Patients with post-concussion syndrome have been shown to have deficits on tests of short term memory, divided attention, multi-tasking, information processing speed, and reaction time, as well as alteration in mood and emotional functioning. Many patients have other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer outcome, while resolution of the sleep disturbance is associated with improvement in cognitive functioning.
Despite recent evidence of the correlation between sleep quality and recovery from traumatic brain injury, and the well-established role of sleep in neural plasticity and neurogenesis, there have been virtually no direct studies of the causal effects of sleep on recovery following mTBI. However, it is quite likely that sleep plays a critical role in recovery following brain injury.
A particularly promising non-pharmacologic approach that shows potential in improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright light therapy. For the proposed investigation, the investigators hypothesize that bright light therapy may be helpful in improving the sleep of patients with a recent history of mTBI and may also have other mood elevating effects, both of which should promote positive treatment outcome in these individuals. Bright light therapy may increase the likelihood that they will recover more quickly, benefit more extensively from other forms of therapy, and build emotional and cognitive resilience.
This study will also have a healthy control (HC)/effect localization arm that will assist in identifying and mapping the brain systems before and after light exposure so that researchers may develop further insights into the relationship between concussion, light exposure, sleep, and brain function. This healthy control arm will also provide brain targets for study in the analysis of the Main Study Arm.
- Conditions
- Concussion, Mild, Post-Concussion Symptoms, Sleep Problems
- Being tested
- mTBI wavelength-1 bright light, mTBI wavelength-2 bright light, HC wavelength-1 bright light, HC wavelength-2 bright light
- Keywords
- Mild traumatic brain injury, Concussion, Sleep problems, Brain imaging, fMRI
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mTBI wavelength-1 bright lightDevice
6 weeks of daily light exposure, 30 minutes per morning
mTBI wavelength-2 bright lightDevice
6 weeks of daily light exposure, 30 minutes per morning
HC wavelength-1 bright lightDevice
30 minutes of light exposure
HC wavelength-2 bright lightDevice
30 minutes of light exposure
| Study group | Role | What they receive |
|---|---|---|
| mTBI wavelength-1 bright light | Experimental | 30 minutes daily light exposure for 6 weeks Receives: Device: mTBI wavelength-1 bright light |
| mTBI wavelength-2 bright light | Placebo comparator | 30 minutes daily light exposure for 6 weeks Receives: Device: mTBI wavelength-2 bright light |
| HC wavelength-1 bright light | Experimental | 30 minutes of light exposure Receives: Device: HC wavelength-1 bright light |
| HC wavelength-2 bright light | Placebo comparator | 30 minutes of light exposure Receives: Device: HC wavelength-2 bright light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) subscale measurement that was used is overall sleep quality, which is derived from question 6 on the assessment and uses a Likert scale of 0 to 3. A score of 0 represents "very good" sleep quality (better outcome), while a measurement of 3 represents "very bad" sleep quality (worse outcome).
Measured: Post 6-week intervention
Sleep Quality - Actigraphy Sleep Efficiency
Sleep Efficiency is the overall percentage of time that the participant was scored as sleeping during their night of sleep (range: 0-100%). Higher percentages suggest higher sleep quality and a better outcome.
Measured: Post 6-week intervention
Sleep Quality - Actigraphy Wake After Sleep Onset
Wake After Sleep Onset (WASO) is how many minutes the participant, during their night of sleep, was determined to be awake after their sleep onset. Sleep onset is defined as a state of at least 2 minutes of uninterrupted sleep. Higher values indicate a worse outcome (range: 1-125 minutes).
Measured: Post 6-week intervention
Executive Function Task - Multi-Source Interference Task (MSIT)
Neural activation during functional magnetic resonance imaging (fMRI) measuring executive functioning using the MSIT.
Measured: Post 6-week intervention
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
The Automated Neuropsychological Assessment Metrics (ANAM) is a neuropsychological battery that uses individual tests to measure cognitive efficiency in areas including attention, concentration, reaction time, memory, processing speed, and decision making. Subscale scores are put in terms of a throughput score, which is calculated to be a ratio of correct responses per minute, as a way to measure cognitive efficiency in the participant; as such, the units for the throughput scores would be in terms of correct responses/minute. Higher throughput scores indicate increased levels of cognitive efficiency in the relevant subscale. The throughput score ranges for the ANAM subscales are:
code substitution learning: 0-147 responses per minute procedural reaction time: 0-151 responses per minute mathematical processing: 0-145 responses per minute matching to sample: 0-97 responses per minute code substitution delayed: 0-155 responses per minute
Measured: Post 6-week intervention
Performance on Neuropsychological Assessment - Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses all of its subscales to calculate the RBANS total score (index). To obtain the RBANS total score (index), the raw scores of the subtests must first be computed into index scores for their relevant subscale (different subtest raw scores feed into specific subscales) using RBANS specific tables that have scaled scores embedded and are normed for the age of the participant. The index scores of each subscale are then summed together to get the Sum of Index Scores, which has a possible range of 200-800. Once the Sum of Index Scores is found, the total score (index) is then found using another RBANS specific table with scaled scores embedded within it. The total score (index) has a possible range of 40-160, with a higher total score (index) is related to a better outcome.
Measured: Post 6-week intervention
Performance on Neuropsychological Assessment - Psychomotor Vigilance Task
The Psychomotor Vigilance Task (PVT) is a task that tests alertness by having the participant press a button every time they see a stimulus image appear on a screen. This image is presented at random 2-10 second intervals throughout the entirety of the task. The reaction time (RT) is one of the PVT measurements and is the time, measured in milliseconds, that it takes for the participant to view the stimulus image and then press the button, confirming that they have indeed viewed the stimulus image at that time. The PVT measures speed using the following equation: 1/RT * 1000. The PVT measurement used here is average speed, so all the calculated speeds were then averaged over the entire trial period to obtain the final value for that trial at that time point (post-tx 1,2,3). Since the PVT is a timed measurement of reaction times, lower scores are considered 'better' or indicate an increased level of vigilance.
Measured: Post 6-week intervention
Daytime Sleepiness - Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire that characterizes the likelihood of the participant 'dozing off' during typical daily activities over their last 2 weeks, and uses a 0-3 point Likert scale, where 0 corresponds to "Would never doze" and 3 corresponds to having a "High chance of dozing" during the activity in question. The ESS score is calculated by adding up all the scores for each question, which means that the ESS score has a range of 0-24, while a higher score indicates that the participant had more issues with daytime sleepiness (worse outcome).
Measured: Post 6-week intervention
Daytime Sleepiness - Functional Outcome of Sleep Questionnaire
The Functional Outcome of Sleep Questionnaire (FOSQ) questions 1-26 use a 1-4 (ordinal) likert (1 = "No difficulty" with sleepiness, 4 = "Yes, extreme difficulty" with sleepiness) and the participant also has the option of putting 0 = "I don't do this activity for other reasons".
FOSQ questions 27-30 use a 1-4 Likert scale where 1 = "Very low" in terms of characterizing the level that sleepiness affects different aspects of their intimate romantic relations, while a 4 = "High" amount of impact on their intimate romantic relations.
The FOSQ total score measurement is determined by calculating the mean of all 5 subscale scores and then multiplying that value by 5 (range: 0-24). A higher score indicates that the participant had more issues with daytime sleepiness.
Measured: Post 6-week intervention
Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire)
The Rivermead Post-Concussion Symptoms Questionnaire (RPCSQ) will be used to assess post-concussive symptoms related to sleep. All questions on the RPCSQ use a 0 to 4 Likert scale concerning the severity of experiencing differing symptoms, where 0 = "not experienced" and 4 = "severe problem". As such, having a higher score is indicative that the participant is having more serious sleep issues related to their head injury. The RPCSQ subscale measurements that were used below are: RPQ3, which is the summed scores from the first 3 questions on the form, with the subscale total ranging from 0-12, and RPQ13, which is the summed scores from questions 4 to 16 on the form, with the subscale total ranging from 0-52. The RPQ3 subscale is associated with earlier symptom clusters of post-concussive symptoms as they relate to sleep disturbances, while the RPQ13 subscale is associated with later symptom clusters of post-concussive symptoms as they relate to sleep disturbances.
Measured: Post 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionSep 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Responsible party
- Principal investigator, William D. Killgore, University of Arizona
- Investigators
- William D Killgore, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374918
- Sponsor's protocol ID
- 1404301151
- Status last verified
- Jun 2021
- First submitted
- 15 Oct 2014
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02374918
- Acronym / sponsor ID
- 1404301151
- Conditions
- Concussion, Mild, Post-Concussion Symptoms, Sleep Problems
- Keywords
- Mild traumatic brain injury, Concussion, Sleep problems, Brain imaging, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research Acquisition Activity
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.
Detailed description
Mild traumatic brain injuries (mTBI) or "concussions" are an increasingly prevalent injury in the investigators society. Patients with post-concussion syndrome have been shown to have deficits on tests of short term memory, divided attention, multi-tasking, information processing speed, and reaction time, as well as alteration in mood and emotional functioning. Many patients have other vague complaints including fatigue, dizziness, irritability, sleep disturbances, and chronic headaches. Furthermore, sleep disruption of one of the most common complaints in patients suffering from traumatic brain injuries, with as many as 40 to 65% of patients with mTBI complaining of insomnia. Sleep problems in these patients are associated with poorer outcome, while resolution of the sleep disturbance is associated with improvement in cognitive functioning.
Despite recent evidence of the correlation between sleep quality and recovery from traumatic brain injury, and the well-established role of sleep in neural plasticity and neurogenesis, there have been virtually no direct studies of the causal effects of sleep on recovery following mTBI. However, it is quite likely that sleep plays a critical role in recovery following brain injury.
A particularly promising non-pharmacologic approach that shows potential in improving/modifying abnormalities of the circadian rhythm and sleep-wake schedule is bright light therapy. For the proposed investigation, the investigators hypothesize that bright light therapy may be helpful in improving the sleep of patients with a recent history of mTBI and may also have other mood elevating effects, both of which should promote positive treatment outcome in these individuals. Bright light therapy may increase the likelihood that they will recover more quickly, benefit more extensively from other forms of therapy, and build emotional and cognitive resilience.
This study will also have a healthy control (HC)/effect localization arm that will assist in identifying and mapping the brain systems before and after light exposure so that researchers may develop further insights into the relationship between concussion, light exposure, sleep, and brain function. This healthy control arm will also provide brain targets for study in the analysis of the Main Study Arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mTBI wavelength-1 bright light | Experimental | Device: mTBI wavelength-1 bright light30 minutes daily light exposure for 6 weeks |
| mTBI wavelength-2 bright light | Placebo comparator | Device: mTBI wavelength-2 bright light30 minutes daily light exposure for 6 weeks |
| HC wavelength-1 bright light | Experimental | Device: HC wavelength-1 bright light30 minutes of light exposure |
| HC wavelength-2 bright light | Placebo comparator | Device: HC wavelength-2 bright light30 minutes of light exposure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age range between 18 and 50.
- The primary language of the subjects must be English.
- Subjects have experienced a "concussion" or mTBI within the preceding 18 months, but no sooner that 4 weeks prior to their screening. The occurrence of a concussion or mTBI must be documented by a medical report or other professional witness documentation.
- If documented, Glasgow Coma Scale in the range of 13-15 following the injury.
- Subjects must have complaints of sleep difficulties that emerged or worsened following the most recent head injury.
Key exclusion criteria (10 listed)
- Any other history of neurological illness, current Diagnostic Statistical Manual (DSM-IV) Axis I disorder, lifetime history of psychotic disorder, or head injury with loss of consciousness > 30 minutes
- Complicating medical conditions that may influence the outcome of neuropsychological assessment or functional imaging (e.g., HIV, brain tumor, etc.)
- Abnormal visual acuity that is not corrected by contact lenses
- Metal within the body, claustrophobia, or other contraindications for neuroimaging
- Less than 9th grade education
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 |
|---|---|---|
| mTBI wavelength-1 bright light6 weeks of daily light exposure, 30 minutes per morning | Device | mTBI wavelength-1 bright light |
| mTBI wavelength-2 bright light6 weeks of daily light exposure, 30 minutes per morning | Device | mTBI wavelength-2 bright light |
| HC wavelength-1 bright light30 minutes of light exposure | Device | HC wavelength-1 bright light |
| HC wavelength-2 bright light30 minutes of light exposure | Device | HC wavelength-2 bright light |
Primary outcome
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
Time frame: Post 6-week intervention
The Pittsburgh Sleep Quality Index (PSQI) subscale measurement that was used is overall sleep quality, which is derived from question 6 on the assessment and uses a Likert scale of 0 to 3. A score of 0 represents "very good" sleep quality (better outcome), while a measurement of 3 represents "very bad" sleep quality (worse outcome).
Sleep Quality - Actigraphy Sleep Efficiency
Time frame: Post 6-week intervention
Sleep Efficiency is the overall percentage of time that the participant was scored as sleeping during their night of sleep (range: 0-100%). Higher percentages suggest higher sleep quality and a better outcome.
Sleep Quality - Actigraphy Wake After Sleep Onset
Time frame: Post 6-week intervention
Wake After Sleep Onset (WASO) is how many minutes the participant, during their night of sleep, was determined to be awake after their sleep onset. Sleep onset is defined as a state of at least 2 minutes of uninterrupted sleep. Higher values indicate a worse outcome (range: 1-125 minutes).
Executive Function Task - Multi-Source Interference Task (MSIT)
Time frame: Post 6-week intervention
Neural activation during functional magnetic resonance imaging (fMRI) measuring executive functioning using the MSIT.
Performance on Neuropsychological Assessment - Automated Neuropsychological Assessment Metrics
Time frame: Post 6-week intervention
The Automated Neuropsychological Assessment Metrics (ANAM) is a neuropsychological battery that uses individual tests to measure cognitive efficiency in areas including attention, concentration, reaction time, memory, processing speed, and decision making. Subscale scores are put in terms of a throughput score, which is calculated to be a ratio of correct responses per minute, as a way to measure cognitive efficiency in the participant; as such, the units for the throughput scores would be in terms of correct responses/minute. Higher throughput scores indicate increased levels of cognitive efficiency in the relevant subscale. The throughput score ranges for the ANAM subscales are: code substitution learning: 0-147 responses per minute procedural reaction time: 0-151 responses per minute mathematical processing: 0-145 responses per minute matching to sample: 0-97 responses per minute code substitution delayed: 0-155 responses per minute
Performance on Neuropsychological Assessment - Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Post 6-week intervention
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses all of its subscales to calculate the RBANS total score (index). To obtain the RBANS total score (index), the raw scores of the subtests must first be computed into index scores for their relevant subscale (different subtest raw scores feed into specific subscales) using RBANS specific tables that have scaled scores embedded and are normed for the age of the participant. The index scores of each subscale are then summed together to get the Sum of Index Scores, which has a possible range of 200-800. Once the Sum of Index Scores is found, the total score (index) is then found using another RBANS specific table with scaled scores embedded within it. The total score (index) has a possible range of 40-160, with a higher total score (index) is related to a better outcome.
Performance on Neuropsychological Assessment - Psychomotor Vigilance Task
Time frame: Post 6-week intervention
The Psychomotor Vigilance Task (PVT) is a task that tests alertness by having the participant press a button every time they see a stimulus image appear on a screen. This image is presented at random 2-10 second intervals throughout the entirety of the task. The reaction time (RT) is one of the PVT measurements and is the time, measured in milliseconds, that it takes for the participant to view the stimulus image and then press the button, confirming that they have indeed viewed the stimulus image at that time. The PVT measures speed using the following equation: 1/RT * 1000. The PVT measurement used here is average speed, so all the calculated speeds were then averaged over the entire trial period to obtain the final value for that trial at that time point (post-tx 1,2,3). Since the PVT is a timed measurement of reaction times, lower scores are considered 'better' or indicate an increased level of vigilance.
Daytime Sleepiness - Epworth Sleepiness Scale
Time frame: Post 6-week intervention
The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire that characterizes the likelihood of the participant 'dozing off' during typical daily activities over their last 2 weeks, and uses a 0-3 point Likert scale, where 0 corresponds to "Would never doze" and 3 corresponds to having a "High chance of dozing" during the activity in question. The ESS score is calculated by adding up all the scores for each question, which means that the ESS score has a range of 0-24, while a higher score indicates that the participant had more issues with daytime sleepiness (worse outcome).
Daytime Sleepiness - Functional Outcome of Sleep Questionnaire
Time frame: Post 6-week intervention
The Functional Outcome of Sleep Questionnaire (FOSQ) questions 1-26 use a 1-4 (ordinal) likert (1 = "No difficulty" with sleepiness, 4 = "Yes, extreme difficulty" with sleepiness) and the participant also has the option of putting 0 = "I don't do this activity for other reasons". FOSQ questions 27-30 use a 1-4 Likert scale where 1 = "Very low" in terms of characterizing the level that sleepiness affects different aspects of their intimate romantic relations, while a 4 = "High" amount of impact on their intimate romantic relations. The FOSQ total score measurement is determined by calculating the mean of all 5 subscale scores and then multiplying that value by 5 (range: 0-24). A higher score indicates that the participant had more issues with daytime sleepiness.
Post-Concussive Symptoms (Rivermead Post-Concussion Symptoms Questionnaire)
Time frame: Post 6-week intervention
The Rivermead Post-Concussion Symptoms Questionnaire (RPCSQ) will be used to assess post-concussive symptoms related to sleep. All questions on the RPCSQ use a 0 to 4 Likert scale concerning the severity of experiencing differing symptoms, where 0 = "not experienced" and 4 = "severe problem". As such, having a higher score is indicative that the participant is having more serious sleep issues related to their head injury. The RPCSQ subscale measurements that were used below are: RPQ3, which is the summed scores from the first 3 questions on the form, with the subscale total ranging from 0-12, and RPQ13, which is the summed scores from questions 4 to 16 on the form, with the subscale total ranging from 0-52. The RPQ3 subscale is associated with earlier symptom clusters of post-concussive symptoms as they relate to sleep disturbances, while the RPQ13 subscale is associated with later symptom clusters of post-concussive symptoms as they relate to sleep disturbances.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William D Killgore, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mTBI wavelength-1 bright light, mTBI wavelength-2 bright light and HC wavelength-1 bright light in people with Concussion, Mild and Post-Concussion Symptoms, run by University of Arizona 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 6 inclusion and 10 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 24 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) (time frame: Post 6-week intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2021.