ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001264370

Ethics application status

Approved

Date submitted

11/09/2026

Date registered

20/10/2026

Date last updated

20/10/2026

Date data sharing statement initially provided

20/10/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Targeting different light wavelengths for posttraumatic stress disorder following traumatic injury: The Light Utilisation in Neuropsychiatric Adaptation (LUNA) Study

Scientific title

Comparing the efficacy of glasses that allow different light wavelengths before bedtime on the severity and risk of developing posttraumatic stress disorder after traumatic injury, a phase 3, post-market clinical trial

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

LUNA (Light Utilisation in Neuropsychiatric Adaptation)

Related trial records

Health condition

Health condition(s) studied:

Posttraumatic Stress Disorder

Generalised Anxiety Disorder

Depression

Insomnia

Sleep disturbance

Reduced quality of life

Circadian disruption

Light sensitivity

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Mental Health

Depression

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Name: Tinted glasses
Severe injuries can lead to PTSD, a psychiatric disorder affecting functioning and well-being. Light exposure can significantly affect the brain and body, altering stress, mood, cognition and sleep. Disruptions to these functions are involved in PTSD development. The effects of light can vary depending on its specific wavelength (colour). This project aims to explore the link between exposure to different wavelengths of light and PTSD risk by using coloured glasses to regulate light exposure. We will examine whether wearing coloured glasses for two weeks, in the three hours before bedtime, can help reduce the severity and risk of developing PTSD.
For 2 weeks, while in hospital, or from home if discharged, participants will be asked to wear their assigned coloured glasses for 3 hours before bed each night. The glasses will be tinted to reduce the entry of specific wavelengths of light into the eye and can be worn over prescription glasses. As the glasses alter colour perception and may cause drowsiness, to minimise the risk of accidents while wearing them, participants will be asked to avoid tasks that require high alertness or accurate colour perception, such as driving, cycling, and operating machinery, and to take extra care in dimly lit environments. During the 2-week intervention period, participants will also be asked to complete daily self-reported sleep diaries and PTSD symptom assessments on a mobile app (MyCap) every morning, which takes approximately 10 minutes combined daily, and wear two devices: one to monitor light exposure (MiEye) and one to track sleep, activity, heart rate information and skin temperature (ActiGraph Leap). The MiEye can be worn over clothes on a lanyard around the participant’s neck or clipped to their clothes via a magnet, and is worn during all waking hours of the 2-week intervention period and charged bedside overnight. The Actigraph Leap is worn like a watch on the wrist, and will ideally be worn continuously for the 2-week intervention period, unless charging is required. These devices should otherwise only be removed during activities they are likely to be damaged during (e.g., showering). Participants will be reminded to wear the glasses in the device instructions. Adherence will be checked through daily sleep diaries during the intervention period and the self-report questionnaires at follow-up.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Devices

Description of the comparator or control

Name: Tinted glasses
For 2 weeks, while in hospital, or from home if discharged, participants will be asked to wear their assigned glasses for 3 hours before bed each night. The glasses will be tinted to limit the entry of specific wavelengths of light into the eye, while still allowing some of the wavelengths that are reduced in the intervention group to pass through. These glasses can be worn over prescription glasses if required. Participants will be asked to avoid tasks that require high alertness or accurate colour perception, such as driving, cycling, and operating machinery, and to take extra care in dimly lit environments. During the 2-week intervention period, participants will also be asked to complete daily self-reported sleep diaries and PTSD symptom assessments on a mobile app (MyCap) every morning, which takes approximately 10 minutes combined daily, and wear two devices: one to monitor light exposure (MiEye) and one to track sleep, activity, heart rate information and skin temperature (ActiGraph Leap). The MiEye can be worn over clothes on a lanyard around the participant’s neck or clipped to their clothes via a magnet, and is worn during all waking hours of the 2-week intervention period and charged bedside overnight. The Actigraph Leap is worn like a watch on the wrist, and will ideally be worn continuously for the 2-week intervention period, unless charging is required. These devices should otherwise only be removed during activities they are likely to be damaged during (e.g., showering). Participants will be reminded to wear the glasses in the device instructions. Adherence will be checked through daily sleep diaries during the intervention period and the self-report questionnaires at follow-up.

Control group

Placebo

Outcomes

Primary outcome [1]

Posttraumatic stress disorder severity

Timepoint [1]

6 weeks post-baseline

Secondary outcome [1]

Posttraumatic stress disorder risk (i.e., diagnosis)

Timepoint [1]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [2]

Severity of Posttraumatic Stress Disorder symptoms

Timepoint [2]

Daily during the 2-week intervention and daily monitoring period

Secondary outcome [3]

Severity of depression symptoms

Timepoint [3]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [4]

Severity of generalised anxiety disorder symptoms

Timepoint [4]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [5]

Quality of life

Timepoint [5]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [6]

Acceptability of the intervention

Timepoint [6]

6 weeks post-baseline

Secondary outcome [7]

Sleep quality

Timepoint [7]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [8]

Insomnia severity

Timepoint [8]

6 weeks post-baseline and 12 weeks post-baseline

Secondary outcome [9]

Circadian rhythm metrics

Timepoint [9]

2-week intervention and daily monitoring period

Secondary outcome [10]

Sleep-wake metrics

Timepoint [10]

2-week intervention and daily monitoring period

Secondary outcome [11]

Heart rate information

Timepoint [11]

2-week intervention and daily monitoring period

Secondary outcome [12]

Skin temperature

Timepoint [12]

2-week intervention and daily monitoring period

Secondary outcome [13]

Posttraumatic stress disorder severity

Timepoint [13]

12 weeks postbaseline

Secondary outcome [14]

Sleep quality

Timepoint [14]

6 weeks post-baseline and 12 weeks post-baseline

Eligibility

Key inclusion criteria

• Aged between 18-65
• Admission to hospital following traumatic injury that warrants admission to the trauma service for longer than 24h, but less than 14 days, excluding time spent in ICU
• Access to personal smartphone or home internet.
• Sufficient English comprehension
• Scores above threshold on the posttraumatic adjustment scale
• Scores across a threshold indicating moderate to high circadian light sensitivity

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

• Potential inability to tolerate or participate in any part of the study protocol, including making informed consent (e.g., due to particular types of injuries, medical treatments, psychiatric and medical conditions.
• Admission resulting from falling from a non-height (e.g., tripping, slipping, fainting), and/or sporting injuries (excluding those in extreme sports).
• Non-Australian visitor and/or does not have current right of access to Medicare.
• Non-direct emergency admission or satellite admission.
• Under police guard.
• Use of medications or treatments that might influence study outcomes.
• Pregnancy or breastfeeding.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The randomisation algorithm will be generated by an independent statistician and will be hidden in REDCap. Group allocation will occur after eligibility is determined and baseline researcher-administered assessments are complete.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation will be performed using a randomisation algorithm in REDCap. Minimisation may be used to balance variables such as sex, SSRI and benzodiazepine use.

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2026

Actual

Date of last participant enrolment

Anticipated

1/10/2031

Actual

Date of last data collection

Anticipated

24/12/2031

Actual

Sample size

Target

460

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Wellcome Trust (Grant Number: 309936/Z/24/Z)

Address [1]

Country [1]

United Kingdom

Primary sponsor type

University

Name

Flinders University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Melbourne

Address [1]

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Alfred Hospital

Address [2]

Country [2]

Australia

Other collaborator category [3]

Hospital

Name [3]

Brigham and Women’s Hospital

Address [3]

Country [3]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2025

Approval date [1]

19/02/2026

Ethics approval number [1]

122122 (Local Reference: Project 673/25)

Summary

Brief summary

Light exposure influences a range of processes involved in the development of PTSD, including hormone release, stress, mood, cognition and sleep. The impact of light varies by wavelength (colour). This study will investigate whether regulating evening light exposure using coloured glasses can reduce symptom severity and the risk of developing PTSD after traumatic injury. Adults admitted to The Alfred Hospital Trauma Service will be asked to complete a two-step screening process that includes a light-sensitivity assessment. Eligible individuals will then complete a baseline assessment, including clinical interviews and questionnaires on mental health and sleep and may provide an optional saliva sample for genetic analysis. Participants will then be randomly assigned to wear one of two types of coloured glasses that selectively filter different wavelengths of light. Participants will wear the glasses for two weeks during the three hours before bedtime, complete brief daily sleep and mood assessments, and wear devices to track light exposure, sleep, activity, heart rate, and skin temperature. Follow-up assessments, including clinical interviews and self-report questionnaires, will be conducted at 6 and 12 weeks post-baseline. We hypothesise that individuals allocated to receive the intervention glasses will have reduced severity and risk of developing PTSD at 6 and 12 weeks post-baseline.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Meaghan O’Donnell

Address

Phoenix Australia, The University of Melbourne, Level 3, 161 Barry St, Carlton, 3053, VIC

Country

Australia

Phone

+61 4 2767 6753

Fax

[email protected]

Contact person for public queries

Name

Elizabeth Buller

Address

Phoenix Australia, The University of Melbourne, Level 3, 161 Barry St, Carlton, 3053, VIC

Country

Australia

Phone

+61 3 9035 7615

Fax

[email protected]

Contact person for scientific queries

Name

Meaghan O’Donnell

Address

Phoenix Australia, The University of Melbourne, Level 3, 161 Barry St, Carlton, 3053, VIC

Country

Australia

Phone

+61 4 2767 6753

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee

• • De-identified individual participant data underlying published results from individuals who provide consent to share data openly will be publicly accessible on reputable data repositories.
• Users must credit the original author
• While all reasonable steps will be taken to minimise any risk of re-identification, individuals accessing participant data must not attempt to re-identify participants under any circumstances.

What individual participant data might be shared?

• De-identified individual participant data:

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
Not yet decided

Where can requests to access individual participant data be made, or data be obtained directly?

• Data repository: Data will be available on a data repository with access links provided in research publications. Until the data repository is available, please contact Elizabeth Buller at [email protected] for any individual personal data queries.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically