Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001453774
Ethics application status
Approved
Date submitted
26/10/2022
Date registered
14/11/2022
Date last updated
18/11/2022
Date data sharing statement initially provided
14/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Whiria Moe—the Sleep Ninja app for young people
Scientific title
Assessing the effect of the Sleep Ninja app on sleep quality and mental health and wellbeing in young people
Secondary ID [1] 307756 0
3612
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 327329 0
Condition category
Condition code
Mental Health 324459 324459 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sleep Ninja app is a mobile phone app which will be used for 5 to 10 minutes per day over 30 days.
The core strategies included in the app are psychoeducation, stimulus control, sleep hygiene and sleep-focused cognitive therapy.
The structure of the Sleep Ninja app includes six training sessions (lessons), a sleep tracking function, recommended bedtimes based on sleep guidelines, reminders to start a wind-down routine each night, a series of sleep tips and general information about sleep. The home screen has three options: train, track, and more.
Users complete training sessions which are delivered through a chat-bot format where the sleep ninja acts as a sleep coach. Training sessions take approximately 5–10 min to complete, and cover: (1) psychoeducation, information about circadian rhythms and the importance of keeping regular sleep schedules; (2) stimulus control, the value of only going to sleep when tired, and strategies that can be used at night when having trouble sleeping; (3) basic sleep hygiene such as avoiding caffeine and stimulating activity in the evenings, suggestions for daytime activities to promote night-time sleep (e.g., exercise, no napping); (4) identifying and planning for high-risk situations, how to get back on track after a late-night or sleep in; (5) cognitive therapy including how to deal with unhelpful thoughts that can prevent falling asleep as well as sleep-related cognitive distortions, and (6) a final review session which summarises all of the material contained in the app.
The user interacts with the app through a forced choice chat-bot format which is responsive to the input of the user, meaning it personalises information and recommendations based on the selections and sleep profile recorded by the participant. Users level up and reach their next ‘belt’ by completing one training session and tracking their sleep for three nights (out of a 7-night period).
Upon completing 3 nights of sleep diary recordings (tracking) a new training session is unlocked. The app alerts the user when there is a new training session available to complete. When another 3 nights of tracking has been completed, the next training session is unlocked.
App analytics will be used to monitor adherence, and for example, the number of completed training sessions as well as usage characteristics.
Intervention code [1] 324336 0
Behaviour
Comparator / control treatment
There is no control in this single arm pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332530 0
A change in the global score of sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 332530 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [1] 413822 0
A change in insomnia severity measured by the Insomnia Severity Index (ISI)
Timepoint [1] 413822 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [2] 413823 0
A change in depressive symptoms as measured by the Patient Health Questionnaire – Adolescent version (PHQ-A)
Timepoint [2] 413823 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [3] 413824 0
Change in Adolescent Sleep Hygiene Scale (ASHS) score
Timepoint [3] 413824 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [4] 413826 0
A change in Maori Cultural Embeddedness as measured by Items for Maori cultural embeddedness (Fox et al., 2018).
Timepoint [4] 413826 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [5] 413827 0
A change in Hua Oranga
The Hua Oranga is a brief, one-page Maori health outcome measure. It is a questionnaire that takes less than five minutes to complete, and ensures services are focusing on areas of wellbeing that are important to Maori.
McClintock, K.K., et al., (2011)
Timepoint [5] 413827 0
Baseline, days 30 and 90 post-commencement of intervention
Secondary outcome [6] 413831 0
A change in The World Health Organisation- Five Well-Being Index (WHO-5)
Timepoint [6] 413831 0
Baseline, days 30 and 90 post-commencement of intervention

Eligibility
Key inclusion criteria
- Aged between 16 and 18 years (inclusive)
- Fluent in English
- Own a smartphone with capacity for downloading apps
- Have internet access and a valid email address
- Live in New Zealand
- Have not used the Sleep Ninja app before.
Minimum age
16 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2022
Actual
Date of last participant enrolment
Anticipated
20/07/2023
Actual
Date of last data collection
Anticipated
20/08/2023
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25080 0
New Zealand
State/province [1] 25080 0

Funding & Sponsors
Funding source category [1] 312022 0
Charities/Societies/Foundations
Name [1] 312022 0
Cure Kids
Country [1] 312022 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 314102 0
None
Name [1] 314102 0
Address [1] 314102 0
Country [1] 314102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311442 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 311442 0
The University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 311442 0
New Zealand
Date submitted for ethics approval [1] 311442 0
20/06/2022
Approval date [1] 311442 0
09/08/2022
Ethics approval number [1] 311442 0
AH24184

Summary
Brief summary
Sleep Ninja has been designed for young people and is specifically aimed to reduce symptoms of insomnia via an evidence based
intervention called cognitive behavioural therapy for insomnia (CBT-I).
The principal aim of this research, led in a bicultural partnership, is to run a pilot trial to test the feasibility and acceptability of Sleep
Ninja for young people in Aotearoa New Zealand. Additionally, we will collect outcome variables to determine the potential efficacy in
this pilot stage.
We aim to understand 1) if Sleep Ninja is feasible for young people to use; 2) whether the app is relevant for young people in
Aotearoa, and for rangatahi Maori; and 3) to understand the potential efficacy for sleep and wellbeing
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121106 0
Dr Nicola Ludin
Address 121106 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 121106 0
New Zealand
Phone 121106 0
+64 9 923 3614
Fax 121106 0
Email 121106 0
n.ludin@auckland.ac.nz
Contact person for public queries
Name 121107 0
Dr Nicola Ludin
Address 121107 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 121107 0
New Zealand
Phone 121107 0
+64 9 923 3614
Fax 121107 0
Email 121107 0
n.ludin@auckland.ac.nz
Contact person for scientific queries
Name 121108 0
Dr Nicola Ludin
Address 121108 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country 121108 0
New Zealand
Phone 121108 0
+64 9 923 3614
Fax 121108 0
Email 121108 0
n.ludin@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified line by line data
When will data be available (start and end dates)?
Following publication, not end date determined
Available to whom?
Legitimate researchers who make a sound proposal
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
via the co-PI Nicola Ludin n.ludin@auckland.ac.nz


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
No additional documents have been identified.