SleepFix for Insomnia in Primary Care

Primary care professionals (GPs, nurses and pharmacists) will be recruited. Primary care professionals will be briefed by the study coordinator and invited to provide consent (in person). As part of the study, primary care professionals will assess new or existing patients with either pre-existing or suspected chronic insomnia (minimum 3 months chronicity) using their own clinical judgement and a 3-item DSM-5 checklist. Following screening by the primary care professionals, eligible patients will be invited to participate in the study through an invitation (SleepFix prescription) provided by the primary care professionals. This will analogous to prescribing medication using a script. Thereafter, participants will complete the following procedures at home in their own time. The invitation will direct all interested potential participants to a dedicated website (www.gpsfix.com.au) where they will use the unique log-in details provided on the invitation to gain access to the website. Participants will undergo additional screening on this webpage. If eligible, participants will provide informed consent digitally. The website will provide participants with a unique code (access code) which is used to gain access to the app (i.e. therapy) once downloaded from the iOS or Google Play store. All expectation setting and instructions for use of SleepFix application will be delivered via the same study website used for onboarding. Short video vignettes will be used to explain these concepts with text to reinforce and will continue to be available throughout the 6-week intervention period (3 weeks of therapy + 3 additional weeks of optional use). The first video explains sleep consolidation therapy, how sleep efficiency is calculated and the concept of sleep pressure. The second video summarises how the app works including how data is used to calculate and adjust sleep window based on sleep efficiency, along with the four stages to the program. The third video will demonstrate how to use the app. The study website will also include a link to a manual to further explain the mobile application, how the treatment works and how to download and use the app This entire onboarding process conducted online will be completed in under 20 minutes. All participants will be provided with a Fitbit with sleep-tracking capability which will sync objective sleep data into their SleepFix sleep diary. Sleep retraining therapy aims to reduce excess time spent in bed and reset sleep by matching time in bed (minimum of five and a half hours) to total sleep time (TST). Once an 80% rate of sleep efficiency (time asleep divided by time in bed multiplied by 100) is achieved, recommended time in bed is extended by fifteen minutes (normally by retiring to bed earlier). Conversely, if sleep efficiency is less than 80% for 3 consecutive days, time in bed is reduced by fifteen minutes. The SleepFix smartphone application replicates this clinical process and calculates the sleep window based on sleep efficiency scores obtained from user input and objective sensor data from the wearable fitness tracker. At commencement of SleepFix application, participants enter average sleep and bedtime data into the smartphone application. The app prescribes a personalised bedtime and rising time. Each morning, participants complete their SleepFix sleep diary. This data is used by the app to automatically titrate their sleep window. There is no interaction required with the SleepFix app at night. There are four stages to the SleepFix application and participants will progress based on sleep anchor times (sleep onset and offset) and sleep efficiency (>80%). Stage 1 and 2 require participants to adhere to bedtimes whilst stages 3 and 4 focus on sleep efficiency. Participants will engage with the therapy every night of the 3 week study period with an optional 3 weeks of continued therapy (decided by participant). Data will be collected during weeks 1-6 inclusive. Adherence to the therapy will be assessed by the number of sleep diary entries and daily sleep-wake parameters: time in bed, sleep efficiency measured using data from the sleep diary and/or objective sensor data from the wearable fitness tracker.