Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000077864
Ethics application status
Approved
Date submitted
2/11/2020
Date registered
29/01/2021
Date last updated
23/02/2023
Date data sharing statement initially provided
29/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Photoreceptor-directed light therapy in Parkinson’s disease
Scientific title
Effect of photoreceptor-directed light therapy on sleep in Parkinson's disease
Secondary ID [1] 302676 0
Nil Known
Universal Trial Number (UTN)
U1111-1260-5696
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 319595 0
Circadian disruption 319915 0
Sleep disruption 319916 0
Condition category
Condition code
Neurological 317533 317533 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplemental light therapy:
Arm 1: High melanopsin light
Arm 2: Low melanopsin light

The ‘high’ melanopsin state has a relatively increased spectral component around the peak sensitivity of the melanopsin photopigment. The ‘low’ melanopsin state has a relatively reduced spectral component in that range compared with the ‘high’ state.
The melanopsin contrast between these states is approximately 25%. Each state’s total radiometric power is approximately 1.4W/m^2 (watts per square metre) and 2.8W/m^2 respectively, measured at 30cm. Of this, 0.445W/m^2 and 0.56W/m^2 respectively is acting on melanopsin photoreceptors, and both states have 0.808W/m^2 attributable to photometric luminance. Both states will not deliver more than the industry standard 10,000 lux at a 16cm viewing distance (e.g. approximately 5,000 lux).

The participant will view the light for 30 minutes daily at home for 4 weeks. The participant will be instructed face to face by one of the research team members on the use of the light.

We personalize the timing (morning or evening) of the daily (30min) light exposure based on a person’s chronotype to control for individual differences in activity and alertness in the morning and evening. Chronotypes will be determined with the Morningness Eveningness questionnaire.

Actigraphy data provide an additional control measure to ensure adherence to the light intervention methodologies; that is, if the participant incorrectly uses the light, the actigraphy data will return lower light exposure when light box should have been used.
Intervention code [1] 318959 0
Treatment: Devices
Comparator / control treatment
The comparator/control arm is the low melanopsin light.
Control group
Dose comparison

Outcomes
Primary outcome [1] 325567 0
Polysomnography (PSG) sleep latency > 8 min difference
Timepoint [1] 325567 0
Participants will be assessed at baseline (day 1-3) before light intervention, 4 weeks (primary timepoint) and 6 weeks post-commencement of light intervention.
Primary outcome [2] 325569 0
Polysomnography (PSG) sleep efficiency > 7 min difference
Timepoint [2] 325569 0
baseline (day 1-3 before light intervention), 4 weeks (primary timepoint) and 6 weeks after light intervention
Primary outcome [3] 325570 0
Dim Light Melatonin Onset determined from salivary samples > 65 min difference
Timepoint [3] 325570 0
baseline (day 1-3 before light intervention), 4 weeks (primary timepoint) and 6 weeks after light intervention
Secondary outcome [1] 388406 0
Pittsburgh Sleep Quality Index > 1.6 difference
Timepoint [1] 388406 0
baseline (day 1-3 before light intervention), 4 weeks and 6 weeks after light intervention
Secondary outcome [2] 388407 0
Epworth Sleepiness Scale > 4.6 difference
Timepoint [2] 388407 0
baseline (day 1-3 before light intervention), 4 weeks and 6 weeks after light intervention
Secondary outcome [3] 388408 0
Motor function: Gait: step velocity > 0.14 m/s difference
Timed walk test on pressure sensitive Mat
Timepoint [3] 388408 0
baseline (day 1-3 before light intervention), 4 weeks and 6 weeks after light intervention
Secondary outcome [4] 388409 0
Motor function: Tremor (postural) > 4 Hz difference
Resting tremor with accelerometer on left and right fingers
Timepoint [4] 388409 0
baseline (day 1-3 before light intervention), 4 weeks and 6 weeks after light intervention

Eligibility
Key inclusion criteria
• People with PD based on the unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Hoehn & Yahr staging (I-IV).
• Healthy eyes with no anterior eye disease (i.e. lens opacities < grade 2 based on LOCS III) and no signs of retinal or optic nerve disease (diabetic retinopathy, glaucoma or age-related macular degeneration) based on ophthalmic examination (determined by an ophthalmologist, PI Feigl)
• Living independently in the community and able to walk unaided
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to comply with study follow up
• Participants having travelled across 2 or more time zones within 90 days before start of the study
• Dementia based on MMSE (<24) and ACE (<82) assessments
• Deep brain stimulation, other device assisted therapies (i.e. red light therapy) or CNS surgery
• Any type of systemic disease or any medical condition (controlled or uncontrolled) other than PD that could be expected to significantly affect the health of a participant
• A periodic limb movement disorder index (PLMI) > 15/hour in PSG
• Significant sleep apnea (AHI apnoea-hypnoea index > 15 events/hour) and loss of REM atonia in PSG
• Recent or recurrent history of musculoskeletal injury or surgery

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power and Sample size calculation are based on established formulae. Mean difference data (effect size) are based on published studies in PD.

All statistical analyses will be performed using SPSS (IBM SPSS, version 23; IBM Corporation, Armonk, NY, USA) and GraphPad Prism (GraphPad Software, Inc., CA, USA). The data will be screened for normality using the Shapiro-Wilk test. Means of the parametric data between the groups before and after light intervention will be compared using ANOVA and non-parametric data using Kruskal Wallis (Dunn’s multiple comparisons) analysis of variance to determine a group difference with p<0.05. Subsequent post-hoc comparison between groups will be assessed using Mann Whitney U test and Bonferroni corrections for multiple comparisons. Pearson or Spearman’s rank correlation coefficients will be calculated to assess bivariate associations. We use linear and logistic regression models to control for covariates (age, gender).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
11/03/2021
Date of last participant enrolment
Anticipated
31/10/2022
Actual
24/10/2022
Date of last data collection
Anticipated
16/12/2022
Actual
6/12/2022
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 31810 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 307115 0
Charities/Societies/Foundations
Name [1] 307115 0
Michael J Fox Foundation for Parkinson's Research
Country [1] 307115 0
United States of America
Funding source category [2] 307116 0
Charities/Societies/Foundations
Name [2] 307116 0
Shake IT Up Australia Foundation
Country [2] 307116 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St., Brisbane Queensland 4001
Country
Australia
Secondary sponsor category [1] 307685 0
None
Name [1] 307685 0
Address [1] 307685 0
Country [1] 307685 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307228 0
QUT Office of Research and ethics Integrety (OREI)
Ethics committee address [1] 307228 0
Ethics committee country [1] 307228 0
Australia
Date submitted for ethics approval [1] 307228 0
03/07/2020
Approval date [1] 307228 0
11/09/2020
Ethics approval number [1] 307228 0
2000000435

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

Contacts
Principal investigator
Name 106478 0
A/Prof Beatrix Feigl
Address 106478 0
Queensland University of Technology
60 Musk Avenue, Kelvin Grove 4059
Queensland
Country 106478 0
Australia
Phone 106478 0
+61 07 31 38 6147
Fax 106478 0
Email 106478 0
[email protected]
Contact person for public queries
Name 106479 0
Beatrix Feigl
Address 106479 0
Queensland University of Technology
60 Musk Avenue, Kelvin Grove 4059
Queensland
Country 106479 0
Australia
Phone 106479 0
+61 07 31 38 6147
Fax 106479 0
Email 106479 0
[email protected]
Contact person for scientific queries
Name 106480 0
Beatrix Feigl
Address 106480 0
Queensland University of Technology
60 Musk Avenue, Kelvin Grove 4059
Queensland
Country 106480 0
Australia
Phone 106480 0
+61 07 31 38 6147
Fax 106480 0
Email 106480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be shared in line with participants confidentiality and according to ethical approval.


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.