ight Therapy for the treatment of post-stroke fatigue

Not Applicable

• Conditions: Stroke; Fatigue; Stroke - Haemorrhagic; Stroke - Ischaemic; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000917831
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the light therapy intervention will be assessed via an audit of study records of the following: 1) recruitment and completion rates (number referred, number eligible, number enrolled, number of withdrawals, trial recruitment rate, trial completion rate), 2) program tolerance (Brief Emotional Experience Scale and Depression Anxiety Stress Scale), 3) program adherence (number of completed treatment sessions versus the number of missed treatment sessions), and 4) program compliance (number of prescribed light therapy sessions vs number of completed light therapy sessions). Barriers to participation, withdrawal, missed light therapy sessions and non-compliance to interventions will be examined using a semi-structured interview.[Feasibility of the light therapy intervention will be assessed at the conclusion of the study.]