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Trial registered on ANZCTR


Registration number
ACTRN12618001668291
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
10/10/2018
Date last updated
8/04/2019
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleep Consolidation Therapy for Insomnia Study

Scientific title
The effectiveness of a mobile application delivering sleep consolidation therapy in people with insomnia symptoms
Secondary ID [1] 295105 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a follow-up study to ACTRN12618000060246

Health condition
Health condition(s) or problem(s) studied:
Insomnia symptoms 308686 0
Condition category
Condition code
Mental Health 307613 307613 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301740 0
Treatment: Devices
Intervention code [2] 312063 0
Treatment: Other
Intervention code [3] 312064 0
Behaviour
Comparator / control treatment
This study is a non-randomised, open label repeated-measures (pre-to-post) trial. All participants will receive the mobile application treatment. There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306595 0
Insomnia symptoms will be measured using the Insomnia Severity Index (ISI).
Timepoint [1] 306595 0
Measurements to assess the primary outcome will be at baseline and week 6
Secondary outcome [1] 348957 0
Subjective sleep quality measured using a likert scale of sleep quality
Timepoint [1] 348957 0
Measurements will be at baseline and weeks 1,2,3,6 and 12.
Secondary outcome [2] 348958 0
Depression will be measured weekly using the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 348958 0
Measurements will be at baseline and weeks 6 and 12.
Secondary outcome [3] 348959 0
Anxiety will be measured at baseline and follow-up using the General Anxiety Disorder (GAD-7)
Timepoint [3] 348959 0
Measurements will be at baseline and weeks 6 and 12.
Secondary outcome [4] 348960 0
Subjective sleepiness measured baseline and follow-up using the Epworth Sleepiness Scale (ESS).
Timepoint [4] 348960 0
Measurements will be at baseline and weeks 6 and 12.
Secondary outcome [5] 348961 0
Fatigue will be measured using a 4-point Likert scale.
Timepoint [5] 348961 0
Measurements will be at baseline and weeks 1,2,3,6 and 12.
Secondary outcome [6] 348962 0
Work productivity will be measured using the adapted Health and Work Performance Questionnaire (HPQ).
Timepoint [6] 348962 0
Measurements will be at baseline and weeks 6 and 12.
Secondary outcome [7] 348963 0
Objective (Fitbit) sleep-wake parameters -total sleep time assessed in those who are allocated to the Fitbit group. This is an exploratory outcome.
Timepoint [7] 348963 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [8] 348964 0
Subjective (diary) sleep-wake parameter, total sleep time, captured via proof-of-concept mobile application.
Timepoint [8] 348964 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [9] 352424 0
Subjective sleep quality measured using sleep onset latency
Timepoint [9] 352424 0
Measurements will be at baseline and weeks 1,2,3,6 and 12.
Secondary outcome [10] 352612 0
Subjective sleep quality measured using wake after sleep onset
Timepoint [10] 352612 0
Measurements will be at baseline and weeks 1,2,3,6 and 12.
Secondary outcome [11] 352613 0
Subjective sleep quality measured using total sleep time.
Timepoint [11] 352613 0
Measurements will be at baseline and weeks 1,2,3,6 and 12.
Secondary outcome [12] 352656 0
Objective (Fitbit) sleep-wake parameters- sleep onset latency assessed in those who are allocated to the Fitbit group. This is an exploratory outcome.
Timepoint [12] 352656 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [13] 352657 0
Objective (Fitbit) sleep-wake parameters wake-time after sleep onset assessed in those who are allocated to the Fitbit group. This is an exploratory outcome.
Timepoint [13] 352657 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [14] 352658 0
Subjective (diary) sleep-wake parameter, sleep onset latency, captured via proof-of-concept mobile application.
Timepoint [14] 352658 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [15] 352659 0
Subjective (diary) sleep-wake parameter, sleep efficiency, captured via proof-of-concept mobile application .
Timepoint [15] 352659 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [16] 352660 0
Subjective (diary) sleep-wake parameter, ratings of sleep quality, captured via proof-of-concept mobile application.
Timepoint [16] 352660 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).
Secondary outcome [17] 352661 0
Subjective (diary) sleep-wake parameter, wake-time after sleep onset, captured via proof-of-concept mobile application.
Timepoint [17] 352661 0
Measurement will be during all therapy aspects of the study (weeks 1-6 inclusive).

Eligibility
Key inclusion criteria
Aged 18-65 years. Able to provide informed consent. English language. Symptoms of insomnia (ISI>15). Access to a smartphone.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
In the 60 participants we predict will give us complete data at 6 weeks (a biased sample of full data completers is likely to be enriched for people who had a favourable response to treatment), we will have the power to estimate a prevalence of “responders” i.e. 7 or more points reduction in ISI (42/60 pts) of 70% with precision of approximately plus/minus 12%.

Proportion of positive results = P = x/N = 0.700
Lower bound = 0.568
Upper bound = 0.812

The prevalence of responders is based upon a study conducted by Morin et al. (1999) in which a treatment responder was classified as an ISI change score of 7 compared to baseline (equivalent to one category on the ISI).

Primary analyses will be undertaken on both a per-protocol and intent-to-treat basis, regardless of withdrawal from study. Treatment end data (week 6) will be compared against baseline data for primary analyses. Wherever applicable, we will employ generalized linear mixed models at all time-points. We will examine the residuals to assess model assumptions and goodness-of-fit. The Fitbit group will be compared against the non-Fitbit group for both primary and secondary analyses. SPSS (Chicago, IL) will be used to conduct analyses. For all tests, we will use 2-sided p-values with alpha = <0.05 level of significance and 95% confidence intervals.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299686 0
Other
Name [1] 299686 0
Cooperative Research Centre for Alertness, Safety and Productivity
Address [1] 299686 0
Cooperative Research Centre for Alertness, Safety and Productivity
270 Ferntree Gully Road
Notting Hill, VIC, 3168
Country [1] 299686 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Road
Glebe NSW, 2037
Country
Australia
Secondary sponsor category [1] 299407 0
None
Name [1] 299407 0
Address [1] 299407 0
Country [1] 299407 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300590 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 300590 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 300590 0
Australia
Date submitted for ethics approval [1] 300590 0
06/06/2018
Approval date [1] 300590 0
26/07/2018
Ethics approval number [1] 300590 0

Summary
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.
Trial website
www.sfix.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84138 0
Prof Ronald Grunstein
Address 84138 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 84138 0
Australia
Phone 84138 0
+61 2 9114 0438
Fax 84138 0
Email 84138 0
ron.grunstein@sydney.edu.au
Contact person for public queries
Name 84139 0
Dr Christopher Gordon
Address 84139 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 84139 0
Australia
Phone 84139 0
+61 2 9114 0000
Fax 84139 0
Email 84139 0
christopher.gordon@sydney.edu.au
Contact person for scientific queries
Name 84140 0
Dr Christopher Gordon
Address 84140 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 84140 0
Australia
Phone 84140 0
+61 2 9114 0000
Fax 84140 0
Email 84140 0
christopher.gordon@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate data will be shared
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary