Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000917831
Ethics application status
Approved
Date submitted
8/06/2021
Date registered
15/07/2021
Date last updated
24/02/2023
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Light Therapy for the treatment of post-stroke fatigue
Scientific title
The Feasibility and Effects of Novel Light Therapy in Individuals with Neurological Conditions- Stroke
Secondary ID [1] 303958 0
None
Universal Trial Number (UTN)
Trial acronym
ENLighTIND-Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 321574 0
Fatigue 321576 0
Condition category
Condition code
Stroke 319314 319314 0 0
Haemorrhagic
Stroke 319315 319315 0 0
Ischaemic
Neurological 320196 320196 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320275 0
Treatment: Devices
Comparator / control treatment
Comparative treatment: Sleep hygiene guidance

The control/comparator group will be an active control group. Sleep hygiene guidance will be disseminated to all participants in the study (i.e. both the green-blue light therapy group and the comparator group). 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.
Control group
Active

Outcomes
Primary outcome [1] 327193 0
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.
Timepoint [1] 327193 0
Feasibility of the light therapy intervention will be assessed at the conclusion of the study.
Secondary outcome [1] 394127 0
Fatigue as measured using the Fatigue Severity Scale.
Timepoint [1] 394127 0
Fatigue will be measured at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [2] 395383 0
Sleep quality as measured using the Pittsburgh Sleep Quality Index.
Timepoint [2] 395383 0
Sleep quality will be measured at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [3] 395384 0
Daytime sleepiness as measured using the Epworth Sleepiness Scale.
Timepoint [3] 395384 0
Daytime sleepiness will be measured at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [4] 395388 0
Sleep environment as measured using the Sleep Environment Questionnaire.
Timepoint [4] 395388 0
Sleep environment will be measured at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [5] 395389 0
Quality of life as measured using specific sub-sales of the Neuro-QoL, including the anxiety, depression, fatigue, positive affect and well-being and sleep disturbance sub-scales.
Timepoint [5] 395389 0
Quality of life will be measured using the abovementioned sub-scales at baseline and following the four-week intervention. The fatigue, sleep disturbance and positive affects and well-being sub-scales of the Neuro-QoL will also be measured following the four-week washout period.
Secondary outcome [6] 395399 0
Habitual sleep timing as measured using wrist-worn actigraphy.
Timepoint [6] 395399 0
Habitual sleep timing will be measured over one week each at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [7] 395400 0
Habitual sleep timing and sleep routines as a composite, measured using the Consensus Sleep Diary.
Timepoint [7] 395400 0
Habitual sleep timing will be measured over one week each at baseline, following the four-week intervention and following the four-week washout period.
Secondary outcome [8] 395401 0
Light exposure in the bedroom as measured using HOBO Pendant light and temperature sensors.
Timepoint [8] 395401 0
Light exposure in the bedroom will be measured over one week at baseline, following the four-week intervention and following a four-week washout period.
Secondary outcome [9] 395402 0
Exploration of genetic markers using saliva sampling techniques.
Timepoint [9] 395402 0
Saliva samples will be collected at baseline, following the four-week intervention and following a four-week washout period.
Secondary outcome [10] 395407 0
Work productivity as measured using the Work Productivity and Activity Impairment Questionnaire.
Timepoint [10] 395407 0
Work productivity will be collected at baseline, following the four-week intervention and following a four-week washout period.
Secondary outcome [11] 395794 0
Mood as measured using the Depression, Anxiety, Stress Scale (DASS-21).
Timepoint [11] 395794 0
Mood will be assessed as baseline, following the four-week intervention and following the four-week washout.
Secondary outcome [12] 395796 0
Emotional wellbeing as measured using the Brief Emotional Experiences Survey (BEES).
Timepoint [12] 395796 0
Emotional wellbeing will be measured with the Brief Emotional Experiences Survey at the end of each week throughout the 4-week intervention period.
Secondary outcome [13] 395797 0
Physical well-being as measured using the Brief Emotional Experiences Survey-Physical.
Timepoint [13] 395797 0
Physical wellbeing will be measured with the Brief Emotional Experiences Survey-Physical at the end of each week throughout the 4-week intervention period.
Secondary outcome [14] 395799 0
Fatigue as measured using the Fatigue Visual Analogue Scale.
Timepoint [14] 395799 0
Fatigue will be measured using the Fatigue Visual Analogue Scale at the end of each week throughout the 4-week intervention period.
Secondary outcome [15] 397482 0
Temperature exposure in the bedroom as measured using HOBO Pendant light and temperature sensors.
Timepoint [15] 397482 0
Temperature exposure will be collected at baseline, following the four-week intervention and following a four-week washout period.
Secondary outcome [16] 397483 0
Habitual sleep quality as measured using wrist-worn actigraphy.
Timepoint [16] 397483 0
Habitual sleep quality will be collected at baseline, following the four-week intervention and following a four-week washout period.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant allocation will be conducted by the investigators delivering the intervention and will be concealed from investigators enrolling and administering testing procedures and performing data analyses.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using simple block randomisation using a table created by computer software (i.e. computerised sequence generation). Sequences will be generated using age and sex as stratification factors.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size estimates (n = 29 per group) were obtained based on a power calculation (a=.05 and power (1-ß)=90%) for the primary outcome (fatigue, using a previously published study [Sinclair et al, 2014]) and factoring in a drop-out rate of 25%.

Normality assumptions will be assessed using Shapiro-Wilk tests. Mixed model analysis of variance (ANOVA) will be used to determine between- and within-group changes for each outcome. Associations between outcomes will be determined using Pearson (for parametric data) and Spearman (for non-parametric data) correlations. Mediation/moderation analyses will be conducted to determine the factors influencing whether an individual is a responder or non-responder to the intervention. Minimal detectable changes will be determined throughout the trial to evaluate the clinical utility of the experimental treatments.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/02/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 34012 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 308340 0
Charities/Societies/Foundations
Name [1] 308340 0
MSWA (The Multiple Sclerosis Society of Western Australia)
Country [1] 308340 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 309156 0
None
Name [1] 309156 0
Address [1] 309156 0
Country [1] 309156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308314 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 308314 0
Ethics committee country [1] 308314 0
Australia
Date submitted for ethics approval [1] 308314 0
Approval date [1] 308314 0
07/12/2020
Ethics approval number [1] 308314 0
2020-01808

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110274 0
Dr Travis Cruickshank
Address 110274 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 110274 0
Australia
Phone 110274 0
+61 08 6304 3416
Fax 110274 0
Email 110274 0
[email protected]
Contact person for public queries
Name 110275 0
Travis Cruickshank
Address 110275 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 110275 0
Australia
Phone 110275 0
+61 08 6304 3416
Fax 110275 0
Email 110275 0
[email protected]
Contact person for scientific queries
Name 110276 0
Travis Cruickshank
Address 110276 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 110276 0
Australia
Phone 110276 0
+61 08 6304 3416
Fax 110276 0
Email 110276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data may be shared upon reasonable request following completion of the study.
When will data be available (start and end dates)?
Data may be available beginning three months and ending five years following the main results publication.
Available to whom?
Researchers will need to submit an expression of interest to study investigators to access the data. If the proposal is deemed methodologically sound, access to the data will be granted.
Available for what types of analyses?
Data will be made available for the type of analysis outlined in the expression of interest/proposal document that is submitted to study investigators.
How or where can data be obtained?
Access to data will be subject to approval by the research team. Once approved, data will be shared via email correspondence with a member of the research team (please contact the Chief Investigator, Dr Travis Cruickshank, on [email protected] for further information).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.