None listed
Conditions
Brief summary
30% of Australians will be affected by Insomnia making it the most common and socially costly sleep disorder. The total cost to Australia in 2010 was estimated to be $10.9 Billion. Insomnia patients suffer from 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 current health system solution to this highly prevalent condition is hypnotic pharmacotherapy. This is despite substantial evidence that drugs are only marginally better than placebo and recommendations against long term drug therapy. Hypnotic therapy also comes with significant risk for a range of side-effects some caused by inappropriate use including falls, car crashes, accidents and potentially increased overall mortality. Cognitive Behaviour Therapy for Insomnia (CBT-I) is a much more effective long-term solution. However, CBT-I suffers from 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 standardised behavioural component of CBT-I that has been specifically tested in isolation and been found to be as effective as multi-component interventions. In Sleep Consolidation Therapy, patients are asked to ‘consolidate’ their sleep-wake schedules (minimum time in bed is five and a half hours). The clinical delivery time for Sleep Consolidation Therapy alone can be relatively short (typically 1 hour delivery + weekly 10 minute telephone calls), but still requires clinician input regularly. Sleep Consolidation Therapy maybe able to be delivered more widely as it has been shown to be feasible in Primary care settings. We have developed a proof-of-concept smartphone application following participatory design and user experience focus groups. We now wish to test the use of this smartphone application to deliver Sleep Consolidation Therapy in participants with Insomnia Disorder. The app has the potential to deliver population-based therapy for Insomnia patients thereby improving therapy options.
Interventions
Participants diagnosed with Insomnia Disorder will have sleep consolidation therapy for insomnia delivered using a proof-of-concept smartphone application. The mobile application calculates and prescribes an individualised sleep window based on sleep efficiency scores (combination of subjective user input and objective sensor data from a wearable fitness tracker). Objective sleep sleep-wake data (time spent in bed, total sleep time, sleep onset latency and wake-time after sleep onset) will be co
Participants diagnosed with Insomnia Disorder will have sleep consolidation therapy for insomnia delivered using a proof-of-concept smartphone application. The mobile application calculates and prescribes an individualised sleep window based on sleep efficiency scores (combination of subjective user input and objective sensor data from a wearable fitness tracker). Objective sleep sleep-wake data (time spent in bed, total sleep time, sleep onset latency and wake-time after sleep onset) will be collected from a wearable fitness tracker and be synced daily with the app. Participants will be able to modify these sleep-wake data based on subjective experiences (daily sleep diary). An initial face-to-face smartphone application information session (approx. 30-40 minutes) will be conducted at the consent visit. This will involve delivery and instructions about using the smartphone application and information on sleep consolidation therapy. The therapy will be explained in detail, emphasizing the prescribed bed and wake times, sleep hygiene and expectations. These information sessions will delivered by the study coordinator as group sessions consisting of up to 2 participants. An experienced sleep psychologist will provide training for the study coordinator. During this initial information session, participants will be provided with a wearable fitness tracker (Fitbit Charge 2™). The Fitbit Charge 2™ is a heart-rate and fitness wristband which provides automatic sleep tracking as well as all-day activity tracking. Participants will be asked to wear the Fitbit Charge 2™ during sleep starting from study commencement up until the final follow-up interview. Participants will engage with the therapy every night of the 3 week study period and will be called twice weekly to monitor progress and discuss issues with noncompliance to sleep consolidation therapy and simple strategies for enhancing adherence. Three weeks following treatment end, participants will be interviewed to gauge their experience regarding the application.
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 No maximum
Healthy volunteers
No
Inclusion criteria
Able to give informed written consent. Literacy in English. Insomnia: symptoms of Insomnia Disorder as diagnosed by the diagnostic and statistical manual of mental disorders, fifth edition criteria for Insomnia Disorder specifically: Difficulty initiating or maintaining sleep or waking up too early for at least three nights per week, for at least three months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty. Assessed by a standardised telephone screening interview to phenotype sleep disorders. Insomnia Severity Index scale score of fifteen or more and global Pittsburgh Sleep Quality Index scale scores of more than five.
Exclusion criteria
Pregnancy or lactation. Shift workers. Current substance dependence. Severe Psychiatric illnesses. Sleep disorders (other than untreated insomnia). Severe cognitive impairment. Recent transmeridian (>2 time zones) travel (within last 1 month). Unable to access and use a smartphone.
Outcome results
None listed