ight Therapy for Fatigue and Daytime Sleepiness in Multiple Sclerosis
- Conditions
- Multiple SclerosisFatigueDaytime sleepinessNeurological - Multiple sclerosis
- Registration Number
- ACTRN12621000773831
- Lead Sponsor
- Edith Cowan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 58
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility- participant recruitment rates as assessed by an audit of study records.[Recruitment rates will be assessed at the conclusion of the study.];Feasibility- participant completion rates as assessed by an audit of study records.[Participant completion rates will be assessed at the conclusion of the study.];Feasibility - program tolerance as assessed by a composite of the Brief Emotional Experience Scale, Brief Emotional Experience Scale-Physical and Depression Anxiety Stress Scale.[Program tolerance will be measured at the conclusion of the study.]
- Secondary Outcome Measures
Name Time Method