None listed
Conditions
Brief summary
Insomnia is a highly prevalent chronic illness with approximately 30% of Australian adults classified as having insomnia or insomnia symptoms. The societal costs are significant with an estimated $10.9 billion in direct and indirect costs in Australia. Insomnia patients have poor health related quality-of-life, increased risk of depression, increased workplace disability and costs, impaired driving performance and increased risk of death from motor and unintentional fatal injuries. The majority of people with insomnia who are treated by primary care physicians will be prescribed hypnotic medications. This is despite substantial evidence that hypnotics are only marginally more effective than placebo and are not effective for long-term management. Hypnotics also come with significant risk for a range of side-effects (falls, car crashes, accidents and potentially increased overall mortality). Cognitive Behaviour Therapy for Insomnia (CBTi) has shown to be more effective long-term solution for people with insomnia. However, CBTi has major drawbacks as it requires specifically trained therapists, and is a complex time-consuming composite therapy that may include therapeutically redundant components. Sleep Consolidation Therapy is a behavioural component of CBTi that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times so that individuals are mildly sleep restricted which promotes sleep onset and decreases wake time in bed. The clinical delivery of the therapy can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but requires clinician input regularly. Sleep Consolidation Therapy has the potential to be delivered more widely as it has been shown to be feasible in primary care settings. We have recently developed a proof-of-concept mobile application following participatory design, user experience focus groups and a pilot study testing the engagement of the application. The mobile application can deliver population-based therapy for insomnia patients thereby improving scalability and treatment options. We now want to test the effectiveness of the mobile application to deliver Sleep Consolidation Therapy in participants with insomnia symptoms.
Interventions
Participants with insomnia symptoms will be provided with sleep consolidation therapy delivered via a mobile application in a fully online study. Sleep Consolidation Therapy is a behavioural component of cognitive behavioral therapy that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times (sleep window)
Participants with insomnia symptoms will be provided with sleep consolidation therapy delivered via a mobile application in a fully online study. Sleep Consolidation Therapy is a behavioural component of cognitive behavioral therapy that has been specifically tested in isolation and found to be as effective as multi-component interventions. The therapy ‘consolidates’ sleep-wake schedules by maximising sleep time through restricting bed time. This is achieved by anchoring bed times (sleep window) so that individuals are mildly sleep restricted which promotes sleep onset and decreases wake time in bed. The mobile application calculates and prescribes an individualised sleep window based on sleep efficiency scores. Sleep efficiency is calculated by the application based on either subjective user input and objective sensor data from a wearable fitness tracker, or a combination of both. This allows the mobile application to be used with or without a wearable fitness tracker. Based on the calculated sleep efficiency, the mobile application adjusts the sleep window accordingly throughout treatment. A randomised proportion of participants will be offered Fitbit usage. The Fitbit is a wearable fitness tracker that will provide automatic sleep tracking. If the mobile application is synchronised with a wearable fitness tracker, objective sleep-wake data (time spent in bed, total sleep time, sleep onset latency and wake-time after sleep onset) will be collected and synced daily with the app. Participants will be able to modify these sleep-wake data based on subjective experiences (daily sleep diary). Participants who receive a Fitbit will commence use of device in conjunction with starting the app-based therapy. They will use the Fitbit and app for 3 weeks (with an optional 3 weeks of additional usage of Fitbit and the app). All Fitbit sleep data (weeks 1-6 inclusive) will be recorded for analysis. All interested potential participants will be directed to a dedicated website (www.sfix.com.au) where they will provide informed consent and undergo screening. Informed consent will be conducted online. Expectation setting and instructions for use of the mobile application will be delivered via a study website. Participants will be directed to three short video vignettes which will be made available on the study page to explain these concepts with text to reinforce. 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. Each video is 1 minute each and will continue to be available throughout the 6 week intervention period. 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. 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 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.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-65 years. Able to provide informed consent. English language. Symptoms of insomnia (ISI>15). Access to a smartphone.
Exclusion criteria
Pregnancy (self-reported). Shift workers. Significant medical conditions likely to either prevent use of App or be exacerbated by sleep restriction (epilepsy, bipolar disorder, heart failure). Self-reported suicidal ideation. Recent travel (destination with more than a 2 hour time difference within last 1 month). Travel during study (destination with more than an hour time difference)
Outcome results
None listed