None listed
Conditions
Brief summary
Individuals following a stroke experience an array of clinical problems, including post stroke fatigue (PSF). PSF has been articulated as a feeling of a lack of energy, weariness and aversion to effort. It is considered one of the most detrimental consequences of a stroke and is estimated to affect between 40% and 70% of individuals at six months post-stroke. These values significantly exceed those in the general population, where fatigue is estimated to affect between 10% and 23% of individuals. These figures are alarming, particularly considering the well-documented associations between greater PSF and shorter survival, institutionalisation, poorer functional outcomes and reduced functional independence and quality of life. Treatment strategies aimed at combating post-stroke fatigue are therefore crucial. To date, evaluation of non-pharmaceutical treatment options for PSF have largely focused on the utility of exercise training and psychotherapy. A recent Cochrane report indicated no positive effect of psychotherapy on PSF. The effects of exercise training on PSF are also equivocal with limited high-quality evidence. While not demonstrated in individuals with stroke, light therapy has been demonstrated to positively impact on fatigue in individuals with Parkinson’s disease, traumatic brain injury, seasonal affective disorder and cancer-related fatigue. Considering its positive effect on fatigue in these populations, particularly individuals with Parkinson’s disease and traumatic brain injury who both display neurological damage, it is conceivable that light therapy will have a positive effect on post-stroke fatigue. The purpose of this study is to evaluate the feasibility and therapeutic effects of light therapy in combination with sleep health, compared to sleep health alone, in individuals experiencing post-stroke fatigue at least three months following a stroke. It is hypothesised that both therapies will be feasible and positively impact on fatigue, however, light therapy plus sleep health guidance will prove to be more therapeutically effective than sleep health guidance alone.
Interventions
This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on post-stroke fatigue. 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 instructions (based on recommendations provided in the manufacturer'
This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on post-stroke fatigue. 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 instructions (based on recommendations provided in the manufacturer's instruction booklet) on how to use the Re-Timer glasses, as well as a sleep diary to complete throughout the intervention period to assist with monitoring adherence to the intervention. Participants that are randomised to the light therapy group will also receive sleep hygiene guidelines as part of the intervention. Sleep hygiene guidelines will be provided in a booklet format. This study-specific sleep hygiene booklet has been produced based on sleep hygiene recommendations from the Australasian Sleep Association and the Sleep Health Foundation. All study participants will receive a 15-30 minute (depending on participant's questions) phone call from a researcher specialising in sleep at the beginning of the intervention period to explain the sleep hygiene guidelines and provide advice on how they may best be able to implement the guidelines into their daily/nightly schedule. Following the four-week intervention, a four-week washout period will be observed to determine the duration of any potential effects of the intervention.
Sponsors
Edith Cowan University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Have experienced an ischaemic or haemorrhagic stroke at least three months prior to enrolling in the study 2) Have persistent self-reported fatigue: a score of greater than 4 on the Fatigue Severity Scale and/or a score of greater than or equal to 5 on the Pittsburgh Sleep Quality Index (indicative of self-perceived poor sleep quality) and/or a score of greater than or equal to 10 on the Epworth Sleepiness Scale (indicative of daytime somnolence) 3) 18 years of age or older 4) Have a modified Rankin Score (mRS) of less than or equal to 4 5) Have the capacity to speak reasonable English, understand verbal and written instructions and be able to complete tests and questionnaires without significant assistance 6) 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) Severe untreated depression (defined by a score of greater than or equal to 11 on the depression component of the DASS-21) 7) Pre-existing chronic fatigue syndrome, narcolepsy or sleep apnoea
Outcome results
None listed