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Trial registered on ANZCTR


Registration number
ACTRN12618000895280
Ethics application status
Approved
Date submitted
23/05/2018
Date registered
28/05/2018
Date last updated
18/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of a Pragmatic Slow Eye Blinking Treatment for Insomnia
Scientific title
The Efficacy of a Pragmatic Slow Eye Blinking Treatment to Improve Sleep Onset Latency, Sleep Efficiency and Overall Mental Health in Patients With Insomnia.
Secondary ID [1] 294975 0
none
Universal Trial Number (UTN)
U1111-1214-5459
Trial acronym
SEB-I (Slow Eye Blinking Treatment for Insomnia)
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Depression 307979 0
Anxiety 307980 0
Insomnia 307981 0
Condition category
Condition code
Mental Health 307015 307015 0 0
Depression
Mental Health 307016 307016 0 0
Anxiety
Mental Health 307017 307017 0 0
Other mental health disorders
Neurological 307040 307040 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a sound file and instructions to implement before going to bed.

Materials include:
(1) Participant Information, Appendix A
(2) Instructions how to complete the intervention, Appendix B
(3) The pragmatic slow eye blinking treatment procedure utilises an electronic metronome recording through a World Wide Web link to a sound file through YouTube (https://www.youtube.com/watch?v=3_almgQbCkI). Metronomes are typically used in musical practice as a way of maintaining rhythm and tempo and can be either electronic or mechanical. The metronome that will be used in the proposed study is an electronic recording that has been set to a rate of 60 beats per minute, which reduces 10 beats per minute over 15 minutes. For each alternating beat, the participants will be required to close and open their eyes, under standardised instructions.
(4) Sleep Intervention Log with instructions, Appendix C

Procedure:
Once recruited, participants will be provided a link access to Qualtrics page. When Qualtrics page is opened participants will have access to information about the proposed research (1), and inclusion criteria. Participants will complete online Qualtrics questionnaires. Participants will then be randomised to either the intervention or waitlist-controlled group.

When a participant is invited to complete the sleep intervention they will be given: (1) instructions how to complete the intervention, a link to a sound file through YouTube, and asked to print the Sleep Intervention Log to complete each night. Participants will self-administer the intervention in their private homes, via the internet, and asked to complete the Sleep Intervention Log each night of the intervention, 10 nights (10x15minutes). Participants will be asked to log back into Qualtrics and complete post-treatment measures on the 10th day of treatment. Intervention adherence will be assessed via the Sleep Intervention Log, which records information about sleep duration, time and awakenings.

Intervention code [1] 301301 0
Behaviour
Intervention code [2] 301302 0
Lifestyle
Comparator / control treatment
Participants randomised to this group will be invited to read the Sleep Hygiene Information specifically designed for this study (Appendix C). Post-Wait-list controlled measures will be completed immediately on the 10th day. Participants will then be asked to complete the intervention.
Control group
Active

Outcomes
Primary outcome [1] 305995 0
Sleep onset latency as measured by self-report (length of time that it takes to accomplish the transition from full wakefulness to sleep; designed specifically for the study)
Timepoint [1] 305995 0
At baseline and on the 11th day via online questionnaire. Everyday via Sleep Intervention Log.
Primary outcome [2] 305996 0
Sleep efficacy as measured by self-report (the ratio of the total time spent asleep in a night compared to the total amount of time spent in bed; designed specifically for the study)
Timepoint [2] 305996 0
At baseline and on the 11th day via online questionnaire. Everyday via Sleep Intervention Log.
Primary outcome [3] 305997 0
Participants will report change in insomnia symptoms as measured by Insomnia Severity Index (ISI)
Timepoint [3] 305997 0
At baseline and on the 11th day via online questionnaire.
Secondary outcome [1] 347250 0
Daytime sleepiness as measured by mean Epworth Sleepiness Scale (ESS)
Timepoint [1] 347250 0
At baseline and on the 11th day via online questionnaire.
Secondary outcome [2] 347251 0
Mental health as measured by mean score on the three sub-scales of the Depression Anxiety Stress Scale (DASS)
Timepoint [2] 347251 0
At baseline and on the 11th day via online questionnaire.

Eligibility
Key inclusion criteria
1- Aged between 18-50 to eliminate the effects of aging on sleep;
2- Have sleep difficulties or have onset and/or maintenance insomnia; and
3- Have the capacity to give consent to the study and follow instructions and procedures, and ability to read and type in English.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- periodic limb movements during sleep
2- diagnosed sleep disruptive medical condition
3- diagnosed Obstructive Sleep Apnoea
4- currently pregnant
5- currently employed in rotating or night-shift work
6- using sedative or stimulant medications or illicit drug use

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following eligibility, participants will then be randomised to either intervention or waitlist-controlled groups using software available on the internet (http://www.supermagnus.com/med/randomizer/index.html) to limit selection bias. Therefore, allocation will be concealed from the team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be simple randomisation using computer software.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori power analysis using the program G*Power3 (Faul, Erdfelder, Lang, & Buchner, 2007) determined that a minimum sample size of 34 participants will be required to sufficiently power the study at the recommended .80 level, a = .05, d= 1.0, N= 34 (Cohen, 1988).

We aim to recruit 50 participants into the trial to allow for loss to follow-up. This ensures that the intervention will still be powered at 80% to detect a meaningful change.

Analyses will be conducted using IBM SPSS Statistics version 22 (IBM Corp, 2013). Before analysing the data, all variables will be examined using frequency distributions for accuracy of data entry and missing values. Exploratory data analyses will involve visual inspection of stem-and-leaf and normality plots, and assumptions testing procedures will be performed on all scale measures to ensure that there are no obvious or serious violations of the assumptions underlying parametric procedures; specifically, normality, linearity, and homogeneity of variance. An alpha level of 0.05 will be used for all statistical analyses. Summary statistics will be used to describe the characteristics of the sample. For all hypotheses, a mixed-design analysis of variance model (2x3 split plot ANOVA) will be used to test for mean differences between three independent groups with repeated measures. Between groups mean comparison between Wait-list, Insomnia Mild (Non-clinical) and Insomnia (Clinical) groups at pre-and at post-intervention (please refer to ISI measure for cut-off) will be analysed. Within subjects comparison in each group pre- to post-intervention (repeated measures pre- to post intervention) will be analysed. 95% confidence intervals will be generated for mean differences. Effect sizes (Cohen’s d) will be reported as small (d ± 0.20), moderate (d ± 0.50), or large (d ± 0.80) effect (Cohen, 1988).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/05/2018
Actual
30/07/2018
Date of last participant enrolment
Anticipated
28/10/2018
Actual
24/09/2018
Date of last data collection
Anticipated
10/11/2018
Actual
4/10/2018
Sample size
Target
50
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 22756 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 299565 0
University
Name [1] 299565 0
RMIT University
Country [1] 299565 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
RMIT University Bundoora, 264 Plenty Road Bundoora Victoria, 3081
Australia
Country
Australia
Secondary sponsor category [1] 298872 0
None
Name [1] 298872 0
Address [1] 298872 0
Country [1] 298872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300462 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 300462 0
Ethics committee country [1] 300462 0
Australia
Date submitted for ethics approval [1] 300462 0
23/05/2018
Approval date [1] 300462 0
11/07/2018
Ethics approval number [1] 300462 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2741 2741 0 0
/AnzctrAttachments/375170-Appendix A.docx (Participant information/consent)
Attachments [2] 2742 2742 0 0
/AnzctrAttachments/375170-Appendix B .docx (Participant information/consent)
Attachments [3] 2743 2743 0 0
/AnzctrAttachments/375170-Appendic C.pdf (Supplementary information)
Attachments [4] 2744 2744 0 0
/AnzctrAttachments/375170-Appendix D.pdf (Supplementary information)

Contacts
Principal investigator
Name 83738 0
Mr Daniel Armstrong
Address 83738 0
RMIT Bundoora, 264 Plenty Road Bundoora Victoria, Australia 3081
Country 83738 0
Australia
Phone 83738 0
+61 3 9925 2000
Fax 83738 0
Email 83738 0
s3060595@student.rmit.edu.au
Contact person for public queries
Name 83739 0
Daniel Armstrong
Address 83739 0
RMIT Bundoora, 264 Plenty Road Bundoora Victoria, Australia 3081
Country 83739 0
Australia
Phone 83739 0
+61 3 9925 2000
Fax 83739 0
Email 83739 0
s3060595@student.rmit.edu.au
Contact person for scientific queries
Name 83740 0
Gerard A. Kennedy
Address 83740 0
RMIT Bundoora, 264 Plenty Road Bundoora Victoria, Australia 3081
Country 83740 0
Australia
Phone 83740 0
+61 3 9925 7457
Fax 83740 0
Email 83740 0
Gerard.kennedy@rmit.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

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