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Trial registered on ANZCTR


Registration number
ACTRN12618000060246
Ethics application status
Approved
Date submitted
20/12/2017
Date registered
17/01/2018
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of a sleep consolidation therapy app for insomnia disorder
Scientific title
The level of patient engagement with a smartphone mobile application of sleep consolidation therapy for insomnia disorder: a pilot study
Secondary ID [1] 293621 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 305892 0
Condition category
Condition code
Mental Health 305086 305086 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299884 0
Treatment: Devices
Comparator / control treatment
This is an uncontrolled open label proof-of-concept study. All participants will receive the smartphone application treatment . There is no control group, with the primary outcome measuring the engagement of the participants with the therapy delivered via a smartphone application.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304264 0
Engagement will be measured as a composite outcome by acceptability and usability. Acceptability will be assessed using the modified Internet Evaluation and Utility Questionnaire (IQ) and modified Internet Impact and Effectiveness Questionnaire (EQ).

Usability will be assessed using System Usability Scale, semi-structured participant interviews and routinely collected usage metrics. Usage metrics include logins, time spent on application, sleep diary entries, mood recordings, concentration game, stage progression and subjective and objective recordings of time in bed and total sleep time.
Timepoint [1] 304264 0
Timepoint (IQ and EQ): Measurements will occur at follow up (week 6 from treatment start.

Timepoint (System Usability Scale and interview): Measurements will occur at follow up (week 6 from treatment start).

Timepoint (usage metrics): Measurements will occur every day for the 6 weeks of the study.
Secondary outcome [1] 341415 0
Insomnia severity symptoms measured by a weekly version of the Insomnia Severity Index (ISI) questionnaire.
Timepoint [1] 341415 0
We are measuring this at baseline (screening), weeks 1, 2, & 3 from treatment start and 6-week follow-up. For the statistical model we are using all data.
Secondary outcome [2] 341416 0
Subjective sleepiness measured by a weekly version of the Epworth Sleepiness Scale (ESS) questionnaire.
Timepoint [2] 341416 0
We are measuring this at baseline (screening), weeks 1, 2, & 3 from treatment start and 6-week follow-up.
Secondary outcome [3] 341417 0
Subjective fatigue measured by a weekly version of the Flinders Fatigue Scale (FFS) questionnaire.
Timepoint [3] 341417 0
Timepoint: We are measuring this at baseline (screening) and weeks 1, 2, & 3 from treatment start.
Secondary outcome [4] 341418 0
Global subjective sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [4] 341418 0
Timepoint: We are measuring this at baseline (screening) and 6-week follow-up.
Secondary outcome [5] 341419 0
Subjective ratings of mood measured through the Hospital Anxiety and Depression Scale (HADS).
Timepoint [5] 341419 0
We are measuring this at baseline (screening) and 6-week follow-up.
Secondary outcome [6] 341420 0
Objective Fitbit Charge 2™ wristband defined sleep-wake parameters (total sleep time, sleep onset latency and wake-time after sleep onset) and adherence to sleep consolidation therapy (total amount of time spent in bed).
Timepoint [6] 341420 0
We are measuring this every day for the 6 weeks of the study.
Secondary outcome [7] 341421 0
Subjective daily-diary sleep-wake parameters captured via proof-of-concept smartphone application (total sleep time, sleep onset latency, sleep efficiency, ratings of sleep quality and wake-time after sleep onset) and adherence to sleep consolidation therapy (total amount of time spent in bed).
Timepoint [7] 341421 0
We are measuring this every day for the 6 weeks of the study.
Secondary outcome [8] 341422 0
Health-related quality of life measured through the 12-item Short Form Health Survey (SF-12).
Timepoint [8] 341422 0
We are measuring this at screening (baseline) and 6-week follow-up.
Secondary outcome [9] 341423 0
Need Satisfaction measured through the Technology-based Experience of Need Satisfaction (TENS) – Task and – Interface
Timepoint [9] 341423 0
Timepoint (TENS-Task): We are measuring this at weeks 1, 2 & 3.

Timepoint (TENS-Interface): We are measuring this at 6-week follow-up.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
Participants will act as their own controls and treatment end data will be compared against baseline data for all analyses. For continuous repeated measures data, we will employ linear mixed effects models at all time-points. We will examine the residuals to assess model assumptions and goodness-of-fit. Change scores of continuous data collected at baseline and post-treatment will be examined by Student’s T-test. SAS (Cary, NC) and 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.

Recruitment
Recruitment status
Completed
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)
NSW

Funding & Sponsors
Funding source category [1] 298235 0
Other
Name [1] 298235 0
Cooperative Research Centre for Alertness, Safety and Productivity
Address [1] 298235 0
Cooperative Research Centre for Alertness, Safety and Productivity
270 Ferntree Gully Road
Notting Hill, VIC, 3168
Country [1] 298235 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] 297353 0
None
Name [1] 297353 0
Address [1] 297353 0
Country [1] 297353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299245 0
Sydney Local Health District (SLHD)
Ethics committee address [1] 299245 0
c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 299245 0
Australia
Date submitted for ethics approval [1] 299245 0
24/11/2017
Approval date [1] 299245 0
16/01/2018
Ethics approval number [1] 299245 0

Summary
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.
Trial website
https://sleepresearch.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79778 0
Dr Christopher Gordon
Address 79778 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 79778 0
Australia
Phone 79778 0
+61291140000
Fax 79778 0
Email 79778 0
christopher.gordon@sydney.edu.au
Contact person for public queries
Name 79779 0
Dr Christopher Gordon
Address 79779 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 79779 0
Australia
Phone 79779 0
+61291140000
Fax 79779 0
Email 79779 0
christopher.gordon@sydney.edu.au
Contact person for scientific queries
Name 79780 0
Dr Christopher Gordon
Address 79780 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050
Country 79780 0
Australia
Phone 79780 0
+61291140000
Fax 79780 0
Email 79780 0
christopher.gordon@sydney.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary