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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001048370p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
8/07/2026
Date registered
Help: Date registered
26/08/2026
Date last updated
Help: Date last updated
26/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The RESET Study: Circadian Rhythm Enhancement through Smart, Evidence Based Wearable Technology and Personalised Intervention
Scientific title
The RESET Study: Circadian Rhythm Enhancement through Smart, Evidence Based Wearable Technology and Personalised Intervention in circadian misalignment adults
Additional trial identifiers [1] 317341 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
sleep disorders 342000 0
circadian disruption 342001 0
Condition category
Condition code
Mental Health 338081 338081 0 0
Other mental health disorders
Public Health 338082 338082 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The purpose of this study is to determine if circadian informed light therapy will improve outcomes for the treatment of circadian misalignment, relative to treatment as usual, for adults presenting at an urban sleep health clinic for treatment of circadian misalignment and willing to participate in the research trial.

The intervention will be delivered by registered psychologists with training in sleep disorder treatment.

Tailored treatment will be delivered face to face or via telehealth where appropriate to participants during individual psychology treatment sessions. Participants will be offered to attend 6 x 1hr treatment sessions over 6 weeks, but the length will be tailored depending on presentation, treatment needs and complexity of presenting concerns or symptoms. Psychologists will administer elements as needed of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy for circadian alignment.

Participants will be issued with a wearable device (MiEye light pin) to monitor light exposure and movement patterns to estimate circadian timing (Dim Light Melatonin Onset [DLMO] and amplitude (of the melatonin rhythm). Participants will wear the device for at least one week prior to their first treatment session, during treatment, and for up to two weeks following treatment. The device will be worn during all daylight hours and charged overnight. The MiEye device will assist in monitoring periods of light exposure to assist in determine treatment adherence during the light therapy treatment.

Participants will undergo a post-illumination pupillary response (PIPR) assessment to determine light sensitivity pre and post treatment.

Information from the wearable device and PIPR assessment will be compiled into a clinician report showing estimated DLMO timing and light sensitivity. The clinician will then use the report to inform their clinical decision making to personalise the treatment including the timing of the light therapy.

Light therapy will be delivered using the Re-Timer portable light therapy glasses. The current version of the Re-Timer light device is portable, battery operated, and administers blue/green light (480-520nm) directly into the visual field at a fixed position from the retina regardless of head position and direction of gaze. The use of the Re-Timer device will be tailored based on participant goals, needs of treatment and if applicable information from clinical reports. Intensity of the light therapy and duration of light exposure will be determined by the treating psychologist based on participant requirements for treatment, ability to tolerate treatment and specific client goals. Light therapy will likely involve 15-60minutes of daily exposure over 1-6 consecutive weeks.

Participants will undergo cognitive performance and reaction time testing prior to beginning treatment and at the end of treatment (pre and post).

To validate the estimated circadian timing from the wearable device (MiEye), we will measure participants DLMO using the gold-standard approach before and after treatment. DLMO will be measured from saliva using salivettes which they will perform themselves at home. Participants will provide 8 saliva samples (from five hours before until two hours after their typical bedtime). Salivettes will be assayed by trained laboratory technicians.
Intervention code [1] 334133 0
Treatment: Other
Intervention code [2] 335064 0
Treatment: Devices
Description of the comparator or control
Participants will be randomised to intervention or treatment as usual.

Treatment as usual will involve tailored psychological treatment (including all elements of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy) without input from the personalised circadian timing or light sensitivity information.
Control group
Active

Outcomes
Primary outcome [1] 345480 0
Change in circadian phase, as indicated by dim light melatonin onset, in minutes to reach 80% of the patients desired circadian timing, or 2hrs or greater phase shift.
Timepoint [1] 345480 0
Baseline (one week prior to treatment commencement) and post treatment (in the night prior to final psychology session or in the week post treatment completion)
Secondary outcome [1] 461826 0
Speed of phase shift, as indicated by number of days to reach 80% of the patients desired circadian rhythm timing, or number of days to achieve 2hrs or greater phase shift.
Timepoint [1] 461826 0
Pre-treatment assessment to time to reach 80% of desired circadian timing accounting for degree of circadian shift required
Secondary outcome [2] 461872 0
Change in total sleep time
Timepoint [2] 461872 0
one week prior to first treatment and in the two weeks post treatment
Secondary outcome [3] 462689 0
Usefulness of clinician report
Timepoint [3] 462689 0
within one week post treatment
Secondary outcome [4] 462690 0
Change in cognitive performance
Timepoint [4] 462690 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [5] 466322 0
Change in sleep timing (bed and wake time)
Timepoint [5] 466322 0
one week prior to first treatment and in the two weeks post treatment
Secondary outcome [6] 466323 0
Change in sleep quality (sleep onset latency minutes and/or time of last awakening)
Timepoint [6] 466323 0
one week prior to first treatment and in the two weeks post treatment
Secondary outcome [7] 466324 0
Change in reaction time
Timepoint [7] 466324 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [8] 466765 0
Sleepiness
Timepoint [8] 466765 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [9] 466766 0
Fatigue
Timepoint [9] 466766 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [10] 466767 0
Depression
Timepoint [10] 466767 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [11] 466768 0
Anxiety
Timepoint [11] 466768 0
one week prior to treatment commencement and in the week following treatment completion
Secondary outcome [12] 466769 0
Productivity
Timepoint [12] 466769 0
one week prior to treatment commencement and in the week following treatment completion

Eligibility
Key inclusion criteria
- 18 years of age or older
- Seeking treatment at the sleep health clinic for circadian disruption
- Willing and able to participate in the research study
- Able to provide informed written consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Not currently seeking treatment for circadian disruption
- Contraindications for use of MiEye device (pacemakers)
- Contraindications for the use of retimer (photosensitivity, skin sensitivity to light, currently taking medications that induce photosensitivity, have or have had any eye conditions such as glaucoma, retinal disorders such as macular degeneration) or have been diagnosed with bipolar disorder.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
27/08/2026
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
23/08/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 321910 0
Government body
Name [1] 321910 0
Australian Research Council
Country [1] 321910 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 324772 0
None
Name [1] 324772 0
Address [1] 324772 0
Country [1] 324772 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320446 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 320446 0
Ethics committee country [1] 320446 0
Australia
Date submitted for ethics approval [1] 320446 0
26/06/2026
Approval date [1] 320446 0
Ethics approval number [1] 320446 0

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

Contacts
Principal investigator
Name 150514 0
A/Prof Nicole Lovato
Address 150514 0
Flinders University, Health and Medical Research Building, Level 3 Sleep Health Clinics, Sports Road, Bedford Park 5042 SA
Country 150514 0
Australia
Phone 150514 0
+61 8 72218307
Fax 150514 0
Email 150514 0
[email protected]
Contact person for public queries
Name 150515 0
Nicole Lovato
Address 150515 0
Flinders University, Health and Medical Research Building, Level 3 Sleep Health Clinics, Sports Road, Bedford Park 5042 SA
Country 150515 0
Australia
Phone 150515 0
+61 8 72218307
Fax 150515 0
Email 150515 0
[email protected]
Contact person for scientific queries
Name 150516 0
Nicole Lovato
Address 150516 0
Flinders University, Health and Medical Research Building, Level 3 Sleep Health Clinics, Sports Road, Bedford Park 5042 SA
Country 150516 0
Australia
Phone 150516 0
+61 8 72218307
Fax 150516 0
Email 150516 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.