Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000867796
Ethics application status
Not yet submitted
Date submitted
30/07/2013
Date registered
6/08/2013
Date last updated
6/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Novel Behavioural Intervention for the Treatment of Sleep-Onset Insomnia: A Pilot Study
Scientific title
The effect of volitional slow eye closure (VSEC) and self-distraction on sleep latency in people with sleep-onset insomnia: A Pilot Study
Secondary ID [1] 282745 0
Nil known
Universal Trial Number (UTN)
U1111-1145-0711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 289479 0
Condition category
Condition code
Public Health 289800 289800 0 0
Other public health
Mental Health 290098 290098 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combined VSEC and self-distraction: VSEC involves intentionally slowing eye closure to that which is seen in drowsy populations. For timing purposes, an electronic metronome will be used for the VSEC group during the one-night in-lab trials, and participants will be provided with one to take home for the POST-trial week. 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 current study is an electronic device that can be set to specific rates of beats-per minute and tone frequencies. For the current study, participants in the VSEC group will be exposed to a rate of 40 beats per minute. For each alternating beat, the participants will be required to close and open their eyes, resulting in a total objective measurement of 20 blinks per minute, under standardized instructions. The use of the 40 beats per minute (equal to 20 blinks per minute) for a period of 15 minutes in the experimental (VSEC) group will help promote slow-eye closure comparable to that which has been previously described. Participants will be taught this technique prior to bed-time on the in-lab study night. The self-distraction technique used in the 'active' group will be identical to that taught to he 'control' group, and will involve following the instruction of the researcher to think of pleasant thoughts or memories prior to bed time.
During the POST week, participants will be required to complete a compliance log-book detailing that they have adhered to the study protocol (completing combined VSEC/self-distraction), and to ensure that they perform the technique they have been assigned, each night before bed.
Intervention code [1] 287408 0
Behaviour
Intervention code [2] 287642 0
Treatment: Other
Comparator / control treatment
The control group will be exposed to self-distraction techniques only. Self-distraction involves thinking of pleasant memories or thoughts at bed-time, for a period of 15 minutes. Participants in this group will be instructed on how to perform this technique initially on the night of the in-lab study (as taught by researcher) and will be required to perform this for a period of 7 nights for the POST week at home. Compliance will be measured by means of a diary.
Control group
Active

Outcomes
Primary outcome [1] 289874 0
Sleep latency/sleep onset time as measured by wrist actigraphy monitoring POST intervention night, compared to PRE intervention data.
Timepoint [1] 289874 0
This will be assessed one week prior to intervention night, and one week POST intervention night.
Secondary outcome [1] 303456 0
To assess the viability of assessing VSEC in a larger sample.
If this trial is successful among the pilot sample, the possibility of trialing the technique among larger-scale populations will be investigated.
Timepoint [1] 303456 0
Upon completion of data acquisition.

Eligibility
Key inclusion criteria
Aged between 18-45 years.
Capacity to give consent to the study and follow instructions and procedures
Clinically significant (moderate-severe) (scores >15) indication of subjective insomnia symptoms as measured by the ISI.
ESS score of <10
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to speak or write English, or ESL.
Diagnosed sleep disruptive medical condition (self-disclosure).
MAPI score of > 0.5
Moderate-Severe depression (BDI) (cut off score > 20).
Moderate- severe anxiety (BAI) (cut-off score >22)
Currently pregnant.
Currently employed in rotating or night-shift work.
Sedative or stimulant medications use (self-disclosure).
Illicit drug use (self-disclosure).

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)
This will be a parallel matched control trial conducted over a period of two weeks to compare the efficacy of combined VSEC and self-distraction treatment compared to a control condition (self-distraction only) in the treatment of sleep parameters in a clinical population of insomnia patients. Following initial contact, participants will be required to complete a questionnaire pack to determine eligibility for the trial portion of the study. Following this, participants will be will be randomized into either the VSEC or control group for the trial. Allocation concealment will be completed via random assignment and computer randomization software. Participants will first be randomly allocated a number (via envelope, chosen by a party not involved in research), which will then be put into computer software, which will allocate participants into groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be determined by randomization software available on the internet (http://www.supermagnus.com/med/randomizer/index.html)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Particpants will be matched on age, gender and ISI scores.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 34 participants will take part in this study, with 17 participants in each group. Participants will be randomly allocated into either placed into the VSEC or control condition using randomization software. Value targets for sleep latency were derived from previously established baseline PSG recordings of sleep latency. Required sample size was determined using Cohens’ (1988) power table.
For a two-tailed, parallel design analysis with a=.05, d= 1.0, N=34. The study will be powered at 80% to detect a true difference in sleep latency (15 mins from baseline) between the VSEC and control condition (Cohen, 88, p 55). Values were determined using Cohens (1988) power table.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1165 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 1166 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 7012 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 287515 0
Charities/Societies/Foundations
Name [1] 287515 0
Institute for Breathing and Sleep (IBAS). This organization is a departmental research group which operates as part of the Sleep and Respiratory department at Austin Health.
Country [1] 287515 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute for Breathing and Sleep (IBAS)
Address
Bowen Centre, Austin Hospital
PO Box 5555, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 286258 0
None
Name [1] 286258 0
Address [1] 286258 0
Country [1] 286258 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289489 0
Austin Health Human Research Ethics Committee (Ec00204)
Ethics committee address [1] 289489 0
Office for Research,
Austin LifeSciences
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia, 3084
Ethics committee country [1] 289489 0
Australia
Date submitted for ethics approval [1] 289489 0
20/08/2013
Approval date [1] 289489 0
Ethics approval number [1] 289489 0
(EC00204)

Summary
Brief summary
Insomnia constitutes a significant societal burden, and is thought to affect a significant portion of the adult population, with research citing between 5-20% of the population is affected by these symptoms. In particular, issues with falling asleep seem to be the most frequent complaint. Current treatments available for insomnia include medications such as benzodiazepines and antidepressants. However, long-term use of these has significant limitations, such as addiction, daytime carry-over effects, and a re-bound insomnia effect when medication use is suspended. Additional and/or alternative treatments include Cognitive Behaviour Therapy (CBT) or relaxation, where patients are taught to remedy symptoms through learning more adaptable coping skills.
Although both treatment options are efficient, they can often be hard to access due to lack of access to scarce resources, time, motivation and the overall cost. When sleep architecture is clinically assessed, people typically undergo a sleep study. Patients are assessed using a number of physiological measures that indicate the time it takes them to get to sleep, how well they are able to maintain sleep, and whether they wake up during the night. Normally, as a person falls asleep, there are noticeable changes in these physiological measures, compared to when they are awake. In particular, when a person is drowsy and about to fall to sleep, slow eye blinks (slow eye closure) feature and these are thought to indicate the start of sleep. The current study is aiming to examine the use of volitional initiation of slow eye closure to see if attempts to manipulate the speed and time at which they occur might accelerate the start of sleep, coupled with self-distraction techniques, when compared to receiving information only about self-distraction alone. This intervention will be tested in insomnia patients over a period of approximately two weeks. First, participants will need to wear a sleep-activity monitoring watch for one week. This acti-watch will assess sleep and activity levels for a period of 7 days. After the one-week period of monitoring activity-sleep is complete, the participant will need to stay in the sleep laboratory at the Austin Hospital for one night. During the stay in the sleep laboratory, participants in the ‘treatment group’ will be instructed in a method of slow eye closure, using an electronic metronome to appropriately time eye closure, and will have a session with a trained sleep specialist about the use of self-distraction strategies. To test the effectiveness of this intervention, a control group will also be used. The control condition will involve taking part in a ‘self-distraction information only’ session. After the participant has learned either the combined self-distraction and eye closure technique or self-distraction-only technique in the laboratory, they will wear the watch for another week while practicing these strategies at home. After the week of wearing the sleep-monitoring watch, the researcher will collect the watch and also have the participant fill in few questionnaires, as well as a feedback sheet about their experience of the research. This feedback will assist in future, larger-scale version of this study and help to identify how the study may be improved.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 41074 0
A/Prof Gerard Kennedy
Address 41074 0
PO Box 14428
Room 3N06
School of Social Sciences and Psychology,
Victoria University
McKechnie St
St Albans, Melbourne, VIC, 3021
Country 41074 0
Australia
Phone 41074 0
+61 3 9919 2481
Fax 41074 0
Email 41074 0
[email protected]
Contact person for public queries
Name 41075 0
Ms Amie Hayley
Address 41075 0
Deakin University
School of Medicine
PO Box 281, Geelong, Victoria,
3220, Australia
Country 41075 0
Australia
Phone 41075 0
+61 3 5260 3564
Fax 41075 0
+61 3 5246 5165
Email 41075 0
[email protected]
Contact person for scientific queries
Name 41076 0
Ms Amie Hayley
Address 41076 0
Deakin University
School of Medicine
PO Box 281, Geelong, Victoria
3220, Australia
Country 41076 0
Australia
Phone 41076 0
+61 3 5260 3564
Fax 41076 0
+61 3 5246 5165
Email 41076 0
[email protected]

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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