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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insomnia Disorder

Condition category

Condition code

Mental Health

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]

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]

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]

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]

Insomnia severity symptoms measured by a weekly version of the Insomnia Severity Index (ISI) questionnaire.

Timepoint [1]

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]

Subjective sleepiness measured by a weekly version of the Epworth Sleepiness Scale (ESS) questionnaire.

Timepoint [2]

We are measuring this at baseline (screening), weeks 1, 2, & 3 from treatment start and 6-week follow-up.

Secondary outcome [3]

Subjective fatigue measured by a weekly version of the Flinders Fatigue Scale (FFS) questionnaire.

Timepoint [3]

Timepoint: We are measuring this at baseline (screening) and weeks 1, 2, & 3 from treatment start.

Secondary outcome [4]

Global subjective sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI).

Timepoint [4]

Timepoint: We are measuring this at baseline (screening) and 6-week follow-up.

Secondary outcome [5]

Subjective ratings of mood measured through the Hospital Anxiety and Depression Scale (HADS).

Timepoint [5]

We are measuring this at baseline (screening) and 6-week follow-up.

Secondary outcome [6]

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]

We are measuring this every day for the 6 weeks of the study.

Secondary outcome [7]

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]

We are measuring this every day for the 6 weeks of the study.

Secondary outcome [8]

Health-related quality of life measured through the 12-item Short Form Health Survey (SF-12).

Timepoint [8]

We are measuring this at screening (baseline) and 6-week follow-up.

Secondary outcome [9]

Need Satisfaction measured through the Technology-based Experience of Need Satisfaction (TENS) – Task and – Interface

Timepoint [9]

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

Sex

Both males and females

Can healthy volunteers participate?

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

19/02/2018

Actual

7/03/2018

Date of last participant enrolment

Anticipated

Actual

9/05/2018

Date of last data collection

Anticipated

Actual

20/07/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Cooperative Research Centre for Alertness, Safety and Productivity

Address [1]

Cooperative Research Centre for Alertness, Safety and Productivity
270 Ferntree Gully Road
Notting Hill, VIC, 3168

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District (SLHD)

Ethics committee address [1]

	c/- Research Development Office
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/11/2017

Approval date [1]

16/01/2018

Ethics approval number [1]

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

Dr Christopher Gordon

Address

Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050

Country

Australia

Phone

+61291140000

Fax

christopher.gordon@sydney.edu.au

Contact person for public queries

Name

Christopher Gordon

Address

Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050

Country

Australia

Phone

+61291140000

Fax

christopher.gordon@sydney.edu.au

Contact person for scientific queries

Name

Christopher Gordon

Address

Woolcock Institute of Medical Research
PO Box M77
Missenden Road, Camperdown
NSW 2050

Country

Australia

Phone

+61291140000

Fax

christopher.gordon@sydney.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A feasibility study of a mobile app to treat insomnia.	2021	https://dx.doi.org/10.1093/tbm/ibaa019

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically