StrokeNCT03125967
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
A study testing Philips GoLite Blu HF3429/60 and Philips LivingColor Aura 70998/60/48 in people with Stroke and Traumatic Brain Injury, run by St. Luke's Rehabilitation Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Traumatic Brain Injury, Non-traumatic Brain Injury
- What is being tested?
- Philips GoLite Blu HF3429/60 and Philips LivingColor Aura 70998/60/48
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
- Male or female, 18 to 85 years of age (to match limits of assessment instruments)
- Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
- Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
- Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
- Normal hearing or corrected to normal hearing
- Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment
Who cannot join
- History of epileptic or other seizure disorder
- Cataract surgery in the past 12 months
- Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment
- Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
- Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
- Neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, Parkinson's disease, Huntington's disease, Alzheimer's disease or other dementias, amyotrophic lateral sclerosis)
Show all 10Show fewer
- Bipolar diagnosis
- Females who are pregnant as determined from subject's medical records or who are breastfeeding
- In active withdrawal from alcohol or street drugs
- Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Luke's Rehabilitation Institute
Spokane, Washington, 99202
Douglas L. Weeks, PhD, 509-939-1316, WeeksDL@st-lukes.org
Douglas L. Weeks, PhD
About this study
Official title: Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.
- Conditions
- Stroke, Traumatic Brain Injury, Non-traumatic Brain Injury
- Being tested
- Philips GoLite Blu HF3429/60, Philips LivingColor Aura 70998/60/48
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips GoLite Blu HF3429/60Other
Exposure to daily morning colored light in the 440-485 nm wavelength range
Philips LivingColor Aura 70998/60/48Other
Exposure to daily morning colored light in the 625-740 nm wavelength range
| Study group | Role | What they receive |
|---|---|---|
| Blue Light | Active comparator | Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM Receives: Other: Philips GoLite Blu HF3429/60 |
| Red Light | Placebo comparator | Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM Receives: Other: Philips LivingColor Aura 70998/60/48 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
24/7 recording of total amount of time asleep via wrist-worn actigraph
Measured: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Sleep Efficiency
Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph
Measured: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Sleep Fragmentation Index
Recording of restlessness during a sleep period via wrist-worn actigraph
Measured: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Frequency of Daytime Naps
Recording of number of naps during daytime via wrist-worn actigraph
Measured: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Secondary outcomes (3)
Karolinska Sleepiness Scale
Patient-report measure of daytime sleepiness
Measured: Baseline and every 3 days plus at study completion, at least 10 days after consent
Wits Pictorial Sleepiness Scale
Patient-report measure of daytime sleepiness
Measured: Baseline and every 3 days plus at study completion, at least 10 days after consent
Fatigue Visual Analog Scale
Patient-report measure of global fatigue
Measured: Baseline and every 3 days plus at study completion, at least 10 days after consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start1 Jan 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Model description
- two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University
- Responsible party
- Principal investigator, Douglas L. Weeks, St. Luke's Rehabilitation Institute
- Investigators
- Douglas L Weeks, PhD, Principal investigator, St. Luke's Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125967
- Sponsor's protocol ID
- StLukesRI
- Status last verified
- May 2022
- First submitted
- 12 Apr 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weeks DL, Crooks E, O'Brien KE, Sprint G, Carter GT, Honn KA. A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study. Contemp Clin Trials. 2024 Dec;147:107736. doi: 10.1016/j.cct.2024.107736. Epub 2024 Nov 6.
PubMed 39510247
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
- ClinicalTrials.gov ID
- NCT03125967
- Acronym / sponsor ID
- StLukesRI
- Conditions
- Stroke, Traumatic Brain Injury, Non-traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- St. Luke's Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Washington State University
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Apr 2017 (actual)
- 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.
The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
| Arm | Type | Receives |
|---|---|---|
| Blue Light | Active comparator | Other: Philips GoLite Blu HF3429/60Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM |
| Red Light | Placebo comparator | Other: Philips LivingColor Aura 70998/60/48Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
- Male or female, 18 to 85 years of age (to match limits of assessment instruments)
- Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
- Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
- Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
Key exclusion criteria (10 listed)
- History of epileptic or other seizure disorder
- Cataract surgery in the past 12 months
- Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment
- Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
- Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
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 |
|---|---|---|
| Philips GoLite Blu HF3429/60Exposure to daily morning colored light in the 440-485 nm wavelength range | Other | Blue Light |
| Philips LivingColor Aura 70998/60/48Exposure to daily morning colored light in the 625-740 nm wavelength range | Other | Red Light |
Primary outcome
Total Sleep Time
Time frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
24/7 recording of total amount of time asleep via wrist-worn actigraph
Sleep Efficiency
Time frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph
Sleep Fragmentation Index
Time frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of restlessness during a sleep period via wrist-worn actigraph
Frequency of Daytime Naps
Time frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Recording of number of naps during daytime via wrist-worn actigraph
3 secondary outcomes
Karolinska Sleepiness Scale
Time frame: Baseline and every 3 days plus at study completion, at least 10 days after consent
Wits Pictorial Sleepiness Scale
Time frame: Baseline and every 3 days plus at study completion, at least 10 days after consent
Fatigue Visual Analog Scale
Time frame: Baseline and every 3 days plus at study completion, at least 10 days after consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 39510247Weeks DL, Crooks E, O'Brien KE, Sprint G, Carter GT, Honn KA. A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study. Contemp Clin Trials. 2024 Dec;147:107736. doi: 10.1016/j.cct.2024.107736. Epub 2024 Nov 6.
- Individual participant dataSharing planned: Undecided
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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.
Douglas L Weeks, PhD principal investigator
St. Luke's Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips GoLite Blu HF3429/60 and Philips LivingColor Aura 70998/60/48 in people with Stroke and Traumatic Brain Injury, run by St. Luke's Rehabilitation Institute 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 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas L Weeks, PhD (509-473-6000, weeksdl@st-lukes.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days). The study lists 4 primary outcomes in all. 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 NCT03125967, which also lists 1 linked publication.
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 9 May 2022.