Recruiting

Light Exposure

Sponsor:

St. Luke's Rehabilitation Institute

Code:

NCT03125967

Conditions

Stroke

Traumatic Brain Injury

Non-traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Philips GoLite Blu HF3429/60

Philips LivingColor Aura 70998/60/48

Study Details

Brief 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 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

Study ID

NCT03125967

Start date

Jan 1, 2017

Status verified date

May, 2022

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
2. Male or female, 18 to 85 years of age (to match limits of assessment instruments)
3. Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
4. Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
5. Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
6. Normal hearing or corrected to normal hearing
7. Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment

Exclusion Criteria:

1. History of epileptic or other seizure disorder
2. Cataract surgery in the past 12 months
3. 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
4. Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
5. Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
6. 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)
7. Bipolar diagnosis
8. Females who are pregnant as determined from subject's medical records or who are breastfeeding
9. In active withdrawal from alcohol or street drugs
10. Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Blue Light

Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM

placebo comparator: Red Light

Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM

Interventions

Philips GoLite Blu HF3429/60

Exposure to daily morning colored light in the 440-485 nm wavelength range

Philips LivingColor Aura 70998/60/48

Exposure to daily morning colored light in the 625-740 nm wavelength range

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 ]
  • Sleep Efficiency [ Time Frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days ]
  • Sleep Fragmentation Index [ Time Frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days ]
  • Frequency of Daytime Naps [ Time Frame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days ]

Central Contacts and Locations

Central contacts

Locations

St. Luke's Rehabilitation Institute

Recruiting

Spokane, Washington, United States, 99202

Contacts

Principal Investigator:

Douglas L. Weeks, PhD

More Information

Sponsor

St. Luke's Rehabilitation Institute

Last update posted

May 9, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Luke's Rehabilitation Institute on 2022-05-09.