Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000118606
Ethics application status
Approved
Date submitted
1/02/2023
Date registered
3/02/2023
Date last updated
22/02/2023
Date data sharing statement initially provided
3/02/2023
Date results information initially provided
3/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Polychromatic Light Treatment for Long-COVID
Scientific title
Circadian Intervention in the Treatment of Insomnia, Fatigue and Depression of Long-COVID
Secondary ID [1] 308839 0
Bronowski Institute BIBN 02201
Universal Trial Number (UTN)
Trial acronym
LT-COV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long Covid 328803 0
Condition category
Condition code
Neurological 325809 325809 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves exposure to polychromatic light (Light Therapy) emitted from a medical device specifically designed to treat the insomnia, depression and fatigue of Long-COVID. As is the case for treatment of other disorders with these symptoms (such as Seasonal Affective Disorder: SAD), patients will be treated for 30 minutes to 1 hour per day with a measure amount of light at 3,000 to 5,000 LUX. Patients will be monitored and assessed during face to face or telehealth consultations on a regularly scheduled basis. This is to ensure that the light is delivered to optimize phototransduction and to maximize the therapeutic effect. The duration of treatment will up to 3 months but may be terminated earlier (no less than 1 month) if a therapeutic effect is observed. The treatment will be delivered by a clinician with over 30 years of experience in treating sleep and psychiatric disorders using this methodology. The patient will be thoroughly briefed and monitored to ensure the light is delivered at the right time in the circadian cycle. The device will be used at home and ongoing device use will be monitored to ensure compliance. The Chief Investigator will be in contact with other health professionals to ensure treatment is compatible with other ongoing treatments. Treatments will be delivered daily at the critical time in the circadian cycle and patients will be monitored/assessed every week to week and a half.
Intervention code [1] 325283 0
Treatment: Devices
Comparator / control treatment
No control group is purposely employed as it is an active, ongoing clinic. However, prior performance measure before the patient commences treatment is employed as the starting baseline. To determine the efficacy of treatment comparison's will be made compared to the baseline.
Control group
Active

Outcomes
Primary outcome [1] 333655 0
Primary Outcome 1: Change in Sleep Features including the amount of sleep, the number of awakenings and the ease at which a patient falls back to sleep as a result of intervention with 1 hour of light exposure. All sleep features will be analyzed together. This instrument employed will be a daily sleep diary kept by the patient and with a structured interview.
Timepoint [1] 333655 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Primary outcome [2] 333656 0
Primary Outcome 2: Change in Fatigue as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [2] 333656 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Primary outcome [3] 333657 0
Primary Outcome 3: Change in depression as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [3] 333657 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [1] 417870 0
Secondary Outcome 1: Change in "brain fog" or cognitive deficits as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [1] 417870 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [2] 417871 0
Secondary Outcome 2: Change in anxiety as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [2] 417871 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [3] 417952 0
Secondary Outcome 3: Change in irritability and moods wing as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [3] 417952 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [4] 417953 0
Secondary Outcome 4: Change in pain as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [4] 417953 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [5] 417954 0
Secondary Outcome 5: Change in internal tremor as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [5] 417954 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [6] 417955 0
Secondary Outcome 6: Change in Parkinsonian features (Bradykinesia, Rigidity, Tremor, (etc.)) as a result of intervention with 1 hour of light exposure. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [6] 417955 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.
Secondary outcome [7] 418083 0
Secondary Outcome 7: Any adverse events such as headache as a result of intervention with 1 hour of light exposure will be recorded if the patient contacts the researcher at any time. This instrument employed will be a structured interview rated on a Likert Scale ranging from 1 to 10 in severity with 10 being the most severe.
Timepoint [7] 418083 0
Timepoint: The key time points for this study are just prior to commencing treatment with assessments every 1 to 1.5 weeks after commencing treatment. The total time the study may run is up to 3 months, it may be terminated earlier if a therapeutic effect is observed.

Eligibility
Key inclusion criteria
Any patient diagnosed with Long-COVID by a qualified medical practitioner is eligible. Being an early exploratory trial, we are examining the generalizability of any therapeutic effect to the general diagnosis of the condition of Long-COVID.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
As above and all patients are treated. The intention is that this serves as a case series study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
While there will be no formal statistical comparisons made in this study the rating of each patient on each of the endpoint will be made prior to starting the treatment and for each time of assessment thereafter.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/08/2022
Date of last participant enrolment
Anticipated
Actual
10/12/2022
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
3
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39350 0
3442 - Woodend North

Funding & Sponsors
Funding source category [1] 313064 0
Self funded/Unfunded
Name [1] 313064 0
Dr Gregory L. Willis
Country [1] 313064 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Bronowski Institute of Behavioural Neuroscience
Address
40 Davy Street
Woodend, Vic 3442
Country
Australia
Secondary sponsor category [1] 314753 0
None
Name [1] 314753 0
N/A
Address [1] 314753 0
N/A
Country [1] 314753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312315 0
The Bronowski Institute Ethical Standards Committee (ESC)
Ethics committee address [1] 312315 0
40 Davy Street, Woodend VIC, 3442 Australia
Ethics committee country [1] 312315 0
Australia
Date submitted for ethics approval [1] 312315 0
01/07/2022
Approval date [1] 312315 0
14/07/2022
Ethics approval number [1] 312315 0
BRON-R-P-CVLT-7-22

Summary
Brief summary
Long-COVID is characterized by symptoms including sleep dysfunction, fatigue, depression, anxiety, anosmia, memory problems, confusional states and others. There is substantial evidence that impaired circadian function contributes to the development of these symptoms. On this basis, a novel approach to treating these symptoms may well be implemented by presenting intense light at a critical time during the light/dark cycle as is achieved with disorders such as season affective disorder (SAD) and Parkinson’s disease. It is hypothesized that this would realign circadian phase and thereby mediating remission in many symptoms of Long-COVID. In view of the breadth of symptoms shared by Long-COVID and prodromal PD alike, we predict that that LT has the potential of providing valuable therapeutic intervention for Long-COVID. While any preliminary results obtained from this case series study will need verification in a controlled trial with a larger sample, this work may provide prima facia evidence that both Long-COVID and PD share a common neuropathological element. This work sets the stage for the expedient development of minimally invasive, effective strategy for treating Long-COVID.

Trial website
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 124218 0
Dr Gregory L. Willis
Address 124218 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442
Country 124218 0
Australia
Phone 124218 0
+61411514980
Fax 124218 0
nil
Email 124218 0
director@bronowski.org
Contact person for public queries
Name 124219 0
Mrs Jane Holth
Address 124219 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442
Country 124219 0
Australia
Phone 124219 0
+61 3 54 271741
Fax 124219 0
nil
Email 124219 0
PLO@bronowski.org
Contact person for scientific queries
Name 124220 0
Dr Greg Willis
Address 124220 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442
Country 124220 0
Australia
Phone 124220 0
+61 411514980
Fax 124220 0
nil
Email 124220 0
director@bronowski.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Mainly because all raw data will be in the resulting publication.


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.