None listed
Conditions
Brief summary
Fatigue and excessive daytime sleepiness are common complaints in individuals living with multiple sclerosis (MS). Fatigue and excessive daytime sleepiness are associated with the emergence and exacerbation of cognitive, motor and mood disturbances and over time lead to impaired rehabilitation outcomes, a decline in the capacity to perform daily activities and reduced quality of life. Treatment of fatigue and daytime somnolence in individuals with MS is therefore essential. Over the last three decades a large body of evidence has accumulated noting the positive effects of non-pharmaceutical strategies for treating sleep and circadian rhythm disturbances in individuals with sleep disorders. Among these, sleep hygiene and light therapy have been shown to be efficacious for sleep and circadian rhythm disruption. Despite this large body of evidence, a relatively small number of studies have evaluated the therapeutic utility of sleep hygiene and light therapy for the treatment of fatigue and daytime sleepiness in individuals with MS. Preliminary evidence suggests that these strategies are feasible and effective in treating fatigue and daytime sleepiness in individuals with traumatic brain injury and Parkinson’s disease. However, there is a fundamental need to replicate these findings in individuals with other neurological conditions, including MS, using larger randomised controlled trials. Furthermore, there is a need to evaluate the synergistic effects of both therapeutic approaches for these populations. The purpose of this study is to evaluate the feasibility and therapeutic effects of light therapy in combination with sleep hygiene, compared to sleep hygiene alone, in individuals with MS. It is hypothesised that both therapies will have positive effects on fatigue and daytime sleepiness, however, light therapy plus sleep hygiene will be more beneficial in reducing symptoms of fatigue and daytime sleepiness in individuals with MS than sleep hygiene alone.
Interventions
This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on fatigue and daytime sleepiness in individuals living with multiple sclerosis. Participants will be asked to wear the Re-Timer glasses for 30 minutes each morning upon awakening for the duration of a four-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
This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on fatigue and daytime sleepiness in individuals living with multiple sclerosis. Participants will be asked to wear the Re-Timer glasses for 30 minutes each morning upon awakening for the duration of a four-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 be asked questions at the end of each week for the duration of the intervention period via text message or email to determine adherence to the intervention. Following the four-week intervention period and follow-up testing, a 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 65 Years
Healthy volunteers
No
Inclusion criteria
1) confirmed clinical diagnosis of multiple sclerosis using the revised McDonald criteria, and in the case of relapsing-remitting MS, clinically verified stable disease in the four weeks leading up to the study. 2) a score of equal to or greater than 4 on the Fatigue Severity Scale and/or a score of equal to or greater than 5 on the Pittsburgh Sleep Quality Index (indicative of self-perceived poor sleep quality) and/or a score of equal to or greater than 10 on the Epworth Sleepiness Scale (indicative of daytime somnolence), 3) between the ages of 18 and 65, 4) the capacity to speak reasonable English, understand verbal and written instructions and be able to complete tests and questionnaires without significant assistance, 5) be able to give informed consent to participate in the study in accordance with the ICH GCP guidelines before initiating any study related procedures.
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) visual abnormalities that may interfere with light therapy, including cataracts, narrow-angle glaucoma or blindness, 5) 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), 6) symptomatology of severe untreated depression (defined by a score of equal to or greater than 11 on the depression component of the DASS-21), and 7) pre-existing chronic fatigue syndrome, narcolepsy or sleep apnoea
Outcome results
None listed