Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001107819
Ethics application status
Approved
Date submitted
22/07/2021
Date registered
20/08/2021
Date last updated
5/04/2023
Date data sharing statement initially provided
20/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of light therapy on daytime sleepiness, fatigue, occupational outcomes and quality of life in individuals following traumatic brain injury
Scientific title
The effectiveness of a 12-week remote-delivered green-blue light therapy intervention on daytime sleepiness, fatigue, activities of daily living and quality of life outcomes in individuals following traumatic brain injury
Secondary ID [1] 304610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ENLighTIND-TBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 322521 0
Daytime sleepiness 322522 0
Fatigue 322523 0
Condition category
Condition code
Neurological 320158 320158 0 0
Other neurological disorders
Injuries and Accidents 320780 320780 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Green-blue light therapy delivered using Re-Timer light therapy glasses

This study will assess the effects of green-blue light therapy, delivered using Re-Timer light therapy glasses, on daytime sleepiness, fatigue, work productivity and quality of life in individuals at least three months following a mild or moderate traumatic brain injury. Participants will be asked to wear the Re-Timer glasses for 30 minutes each morning upon awakening for the duration of a twelve-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 also be provided with a booklet containing sleep hygiene guidelines. This booklet has been developed by the study investigators based on recommendations provided by the National Sleep Foundation and Australasian Sleep Association and contains advice on sleep and wake timing, day and night time habits and lifestyle choices that have been reported to promote healthy sleep. Participants will receive a phone call (up to 30 minutes) from a study investigator specialising in sleep at the beginning of the intervention to discuss how to implement sleep hygiene guidelines into their usual routine. Participants will be asked questions at the end of each week for the duration of the intervention period via text message or email to monitor adherence to the intervention.

Following the twelve-week intervention period and follow-up testing, a four-week washout period will be observed to monitor the duration of any potential effects.
Intervention code [1] 320960 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 and will contain advice on sleep and wake timing, daytime and night time habits and routines that can help to promote good sleep and aspects of the sleep environment that can be adapted for better sleep health, such as lighting, temperature and bedding. These guidelines have been collated into a study-specific booklet by the research team from various sources, including the National Sleep Foundation and the Australasian Sleep Association, and contains advice on sleep and wake timing, day and night time habits and lifestyle choices that have been reported to promote healthy sleep. All study participants will receive a phone call lasting up to 30 minutes (depending on participant questions) 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. This phone call will be conducted by a researcher specialising in sleep. Participants will be asked to follow the sleep hygiene guidelines for the duration of the twelve week intervention period and will be asked questions at the end of each week of the intervention via text message or email to monitor adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 328035 0
Feasibility- participant recruitment rates as assessed by an audit of study records.
Timepoint [1] 328035 0
Recruitment rates will be assessed at the conclusion of the study.
Primary outcome [2] 328036 0
Feasibility- participant completion rates as assessed by an audit of study records.
Timepoint [2] 328036 0
Participant completion rates will be assessed at the conclusion of the study.
Primary outcome [3] 328037 0
Feasibility - program tolerance as assessed by a composite of the Brief Emotional Experience Scale, Depression Anxiety Stress Scale and Intrinsic Motivation Inventory.
Timepoint [3] 328037 0
Program tolerance will be measured at the conclusion of the study.
Secondary outcome [1] 397302 0
Primary outcome: Feasibility- adherence to the program as assessed by an audit of the study records.
Timepoint [1] 397302 0
Program adherence will be measured at the conclusion of the study.
Secondary outcome [2] 397303 0
Primary outcome: Feasibility- compliance with the prescribed program as assessed by an audit of the study records.
Timepoint [2] 397303 0
Compliance with the prescribed program will be measured at the conclusion of the study.
Secondary outcome [3] 397304 0
Fatigue as measured using the Fatigue Severity Scale.
Timepoint [3] 397304 0
Fatigue will be measured at baseline, following the twelve-week intervention and following the four-week washout period.
Secondary outcome [4] 397306 0
Daytime sleepiness as measured using the Epworth Sleepiness Scale.
Timepoint [4] 397306 0
Daytime sleepiness will be measured at baseline, following the twelve-week intervention and following the four-week washout period.
Secondary outcome [5] 398536 0
Quality of life as measured using the Traumatic Brain Injury Quality of Life (TBI-QoL) questionnaire.
Timepoint [5] 398536 0
Quality of life will be measured at baseline and following the 12-week intervention period, with specific sub-scales of the TBI-QoL (fatigue, positive affect and well-being) also being measured following the 4-week washout period.
Secondary outcome [6] 398540 0
Quality of life as measured using sub-scales of the Neuro-QoL.
Timepoint [6] 398540 0
Quality of life will be measured at baseline and following the 12-week intervention, with specific sub-scales of the Neuro-QoL (i.e. sleep disturbance) also being measured following the 4-week washout period.
Secondary outcome [7] 398541 0
Activities of daily living as measured using the Nottingham Extended Activities of Daily Living Scale.
Timepoint [7] 398541 0
Activities of daily living will be measured at baseline and following the 12-week intervention period.
Secondary outcome [8] 398543 0
Sleep quality as measured using the Pittsburgh Sleep Quality Index.
Timepoint [8] 398543 0
Sleep quality will be measured at baseline, following the 12-week intervention period and following the 4-week washout period.
Secondary outcome [9] 398547 0
Sleep environment as measured using the Sleep Environment Questionnaire.
Timepoint [9] 398547 0
Sleep environment will be measured at baseline, following the 12-week intervention period and following the 4-week washout period.
Secondary outcome [10] 398548 0
A composite of daily sleep routines as measured using the Consensus Sleep Diary.
Timepoint [10] 398548 0
Daily sleep routines will be measured for one week each at baseline and following the 12-week intervention.
Secondary outcome [11] 398549 0
Night time light exposure in the bedroom as measured using a HOBO pendant light and temperature sensor.
Timepoint [11] 398549 0
Night time light exposure will be measured each night for one week at baseline and following the 12-week intervention.
Secondary outcome [12] 398550 0
Night time temperature exposure in the bedroom as measured using a HOBO pendant light and temperature sensor.
Timepoint [12] 398550 0
Night time temperature exposure will be measured each night for one week at baseline and following the 12-week intervention.
Secondary outcome [13] 398551 0
Sleep quality as measured using wrist-worn actigraphy.
Timepoint [13] 398551 0
Sleep quality will be measured each night for one week at baseline and following the 12-week intervention.
Secondary outcome [14] 398552 0
Sleep timing as measured using wrist-worn actigraphy.
Timepoint [14] 398552 0
Sleep timing will be measured each day for one week at baseline and following the 12-week intervention.
Secondary outcome [15] 398553 0
Exploration of genetic markers using saliva sampling techniques.
Timepoint [15] 398553 0
Saliva samples will be collected at baseline..
Secondary outcome [16] 398557 0
Assessment of the barriers and facilitators to participation in the intervention as measured using a semi-structured interview.
Timepoint [16] 398557 0
Assessment of the barriers and facilitators to participation in the intervention will be measured upon completion of the study period.
Secondary outcome [17] 398558 0
Emotional state as measured using the Depression, Anxiety, Stress Scale (DASS-21).
Timepoint [17] 398558 0
Emotional state will be measured at baseline, following the 12-week intervention and following the 4-week washout period.
Secondary outcome [18] 419935 0
Participation in activities of daily living will be examined with the Participation Assessment with Recombined Tools- Objective instrument.
Timepoint [18] 419935 0
Participation in activities of daily living will be measured at baseline, following the 12-week intervention and following the 4-week washout period.

Eligibility
Key inclusion criteria
1) Confirmed evidence of mild or moderate TBI as indicated by the American Congress of Rehabilitation Medicine at time of injury,
2) A score of greater than or equal to 4 on the Fatigue Severity Scale and/or a score of greater than or equal to 10 on the Epworth Sleepiness Scale (indicative of EDS),
3) Between the ages of 18 and 85,
4) A score of 17 or more on the telephone version of the Montreal Cognitive Assessment (tele-MoCA, only for those participants who are not recruited through the SPIN Observational Study),
5) Capacity to understand and follow written and verbal instructions in English.
Minimum age
18 Years
Maximum age
85 Years
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) Presence of bipolar disorder,
5) Visual abnormalities that may interfere with light therapy, including cataracts, narrow-angle glaucoma or blindness,
6) 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), and
7) Severe untreated depression (defined by a score of greater than or equal to 11 on the depression component of the DASS-21).

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
Parallel
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 secondary 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
Recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
15/04/2024
Actual
Sample size
Target
58
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308972 0
Government body
Name [1] 308972 0
Insurance Commission of Western Australia via the Neurotrauma Research Program
Country [1] 308972 0
Australia
Funding source category [2] 309205 0
Charities/Societies/Foundations
Name [2] 309205 0
MSWA
Country [2] 309205 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 310167 0
None
Name [1] 310167 0
Address [1] 310167 0
Country [1] 310167 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308859 0
North Metropolitan Heath Service Mental Health Research Ethics and Governance Office
Ethics committee address [1] 308859 0
North Metropolitan Heath Service Mental Health Research Ethics and Governance Office
Gascoyne House, Graylands Campus
Brockway Road
Mount Claremont WA 6010
Ethics committee country [1] 308859 0
Australia
Date submitted for ethics approval [1] 308859 0
22/07/2021
Approval date [1] 308859 0
02/08/2022
Ethics approval number [1] 308859 0
RGS0000004854

Summary
Brief summary
Excessive daytime sleepiness (EDS) and fatigue are common complaints following traumatic brain injury (TBI). EDS and fatigue interfere with daily activities, including work productivity, and negatively impact quality of life (QoL). Treatment of EDS and fatigue in TBI are therefore paramount. Light therapy has been shown to reduce EDS and fatigue in several clinical populations including TBI, however whether these benefits translate into meaningful outcomes, including enhanced work productivity and quality of life, has not been robustly investigated. The proposed study aims to evaluate the effects of light therapy on EDS, fatigue, work productivity and QoL outcomes in people post-TBI. It is hypothesised that both green-blue light therapy plus sleep hygiene guidelines and sleep hygiene guidelines alone will improve EDS, fatigue, work productivity and QoL outcomes, however green-blue light therapy plus sleep hygiene guidelines will produce an effect greater than that of sleep hygiene guidelines alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112146 0
Dr Travis Cruickshank
Address 112146 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 112146 0
Australia
Phone 112146 0
+61 08 6304 3416
Fax 112146 0
Email 112146 0
[email protected]
Contact person for public queries
Name 112147 0
Dr Travis Cruickshank
Address 112147 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 112147 0
Australia
Phone 112147 0
+61 08 6304 3416
Fax 112147 0
Email 112147 0
[email protected]
Contact person for scientific queries
Name 112148 0
Dr Travis Cruickshank
Address 112148 0
Edith Cowan University
270 Joondalup Drive
Joondalup WA 6027
Country 112148 0
Australia
Phone 112148 0
+61 08 6304 3416
Fax 112148 0
Email 112148 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.