None listed
Conditions
Brief summary
Excessive daytime sleepiness (EDS) and fatigue are common complaints following traumatic brain injury (TBI). EDS and fatigue interfere with daily activities, including work productivity, and negatively impact quality of life (QoL). Treatment of EDS and fatigue in TBI are therefore paramount. Light therapy has been shown to reduce EDS and fatigue in several clinical populations including TBI, however whether these benefits translate into meaningful outcomes, including enhanced work productivity and quality of life, has not been robustly investigated. The proposed study aims to evaluate the effects of light therapy on EDS, fatigue, work productivity and QoL outcomes in people post-TBI. It is hypothesised that both green-blue light therapy plus sleep hygiene guidelines and sleep hygiene guidelines alone will improve EDS, fatigue, work productivity and QoL outcomes, however green-blue light therapy plus sleep hygiene guidelines will produce an effect greater than that of sleep hygiene guidelines alone.
Interventions
Intervention: Green-blue light therapy delivered using Re-Timer light therapy glasses
This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on daytime sleepiness, fatigue, work productivity and quality of life in individuals at least three months following a mild or moderate traumatic brain injury. Participants will be asked to wear the Re-Timer glasses for 30 minutes each morning upon awakening for the duration of a twelve-week interven
Intervention: Green-blue light therapy delivered using Re-Timer light therapy glasses This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on daytime sleepiness, fatigue, work productivity and quality of life in individuals at least three months following a mild or moderate traumatic brain injury. Participants will be asked to wear the Re-Timer glasses for 30 minutes each morning upon awakening for the duration of a twelve-week intervention. Re-Timer glasses deliver light at a maximum wavelength of 500nm (230 µW/cm2, 506 lux). Participants will be provided with a booklet which will contain simplified instructions on how to use the Re-Timer glasses. The instruction booklet will be developed by the study team based on manufacturer instructions and recommendations (presented in the Re-Timer user manual). Participants will also be provided with a booklet containing sleep hygiene guidelines. This booklet has been developed by the study investigators based on recommendations provided by the National Sleep Foundation and Australasian Sleep Association and contains advice on sleep and wake timing, day and night time habits and lifestyle choices that have been reported to promote healthy sleep. Participants will receive a phone call (up to 30 minutes) from a study investigator specialising in sleep at the beginning of the intervention to discuss how to implement sleep hygiene guidelines into their usual routine. Participants will be asked questions at the end of each week for the duration of the intervention period via text message or email to monitor adherence to the intervention. Following the twelve-week intervention period and follow-up testing, a four-week washout period will be observed to monitor the duration of any potential effects.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1) Confirmed evidence of mild or moderate TBI as indicated by the American Congress of Rehabilitation Medicine at time of injury, 2) A score of greater than or equal to 4 on the Fatigue Severity Scale and/or a score of greater than or equal to 10 on the Epworth Sleepiness Scale (indicative of EDS), 3) Between the ages of 18 and 85, 4) A score of 17 or more on the telephone version of the Montreal Cognitive Assessment (tele-MoCA, only for those participants who are not recruited through the SPIN Observational Study), 5) Capacity to understand and follow written and verbal instructions in English.
Exclusion criteria
1) Untreated hallucinations or psychosis, 2) Current use of hypnosedative or illicit stimulant drugs, 3) Use of antidepressants, unless the participant has been receiving a stable dose for at least four weeks, 4) Presence of bipolar disorder, 5) Visual abnormalities that may interfere with light therapy, including cataracts, narrow-angle glaucoma or blindness, 6) Transmeridian travel or night shift work in the six weeks leading up to the study (or the intention to travel or undertake night shift during the study), and 7) Severe untreated depression (defined by a score of greater than or equal to 11 on the depression component of the DASS-21).
Outcome results
None listed