The RESET Study: Circadian Rhythm Enhancement through Smart, Evidence Based Wearable Technology and Personalised Intervention

INTERVENTION: 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 X1hr 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 approa CONDITION: Mental Health ‐ Other mental health disorders Public Health ‐ Health service research sleep disorders;circadian disruption; ; sleep disorders ; circadian disruption PRIMARY OUTCOME: 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.[Dim Light Melatonin Onset (DLMO) obtained from saliva and MiEye (estimated) 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)] 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 SECONDARY OUTCOME: Anxiety[GAD‐7 one week prior to treatment commencement and in the week following treatment completion] Change in cognitive performance[Assessed using computerised cognitive assessment task via the Inquisit millisecond library one week prior to treatment commencement and in the week following treatment completion] Change in reaction time[Assessed using computerised reaction time task (psychomotor vigilance task) one week prior to treatment commencement and in the week following treatment completion] Change in sleep quality (sleep onset latency minutes and/or time of last awakening)[self report from participant sleep diaries, and objective sleep assessment from under mattress nearable devices one week prior to first treatment and in the two weeks post treatment] Change in sleep timing (bed and wake time)[self report from participant sleep diaries, and objective sleep assessment from under mattress nearable devices one week prior to first treatment and in the two weeks post treatment] Change in total sleep time[self report from participant sleep diaries, and objective sleep assessment from under mattress nearable devices one week prior to first treatment and in the two weeks post treatment] Depression[PHQ‐9 one week prior to treatment commencement and in the week following treatment completion] Fatigue[Flinders Fatigue Scale one week prior to treatment commencement and in the week following treatment completion] Productivity[WPAI:SHP and questions developed for the study one week prior to treatment commencement and in the week following treatment completion] Sleepiness[Epworth Sleepiness Scale one week prior to treatment commencement and in the week following treatment completion] 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. ; [Dim Light Melatonin Onset (DLMO) obtained from saliva and MiEye (estimated) Pre‐treatment assessment to time to reach 80% of desired circadian timing accounting for degree of circadian shift required] Usefulness of clinician report [qualitative responses via survey questions designed by the study team and/or semi‐structured interviews, one on one, face to face (or via telehealth/phone where appropriate) with a member of the research team within one week post treatment]