Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury

Recruiting

Phase N/A Results N/A

Trial Description

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

Interventions

  • Philips GoLite Blu HF3429/60 or Philips LivingColor Aura 70998/60/48 Other
    Intervention Desc: Exposure to daily morning colored light in either the 440-485 nm wavelength range or the 625-740 nm wavelength range
    ARM 1: Kind: Experimental
    Label: Blue Light
    Description: Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM
    ARM 2: Kind: Experimental
    Label: Red Light
    Description: Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM
  • Philips GoLite Blu HF3429/60 Other
    Intervention Desc: Exposure to daily morning colored light in the 440-485 nm wavelength range
    ARM 1: Kind: Experimental
    Label: Blue Light
    Description: Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM
  • Philips LivingColor Aura 70998/60/48 Other
    Intervention Desc: Exposure to daily morning colored light in the 625-740 nm wavelength range
    ARM 1: Kind: Experimental
    Label: Red Light
    Description: Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM

Outcomes

Type Measure Time Frame Safety Issue
Primary Total Sleep Time From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Primary Sleep Efficiency From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Primary Sleep Fragmentation Index From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Primary Frequency of Daytime Naps From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Secondary Karolinska Sleepiness Scale Baseline and every 3 days plus at study completion, at least 10 days after consent
Secondary Wits Pictorial Sleepiness Scale Baseline and every 3 days plus at study completion, at least 10 days after consent
Secondary Fatigue Visual Analog Scale Baseline and every 3 days plus at study completion, at least 10 days after consent

Sponsors