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Trial registered on ANZCTR


Registration number
ACTRN12613001239752
Ethics application status
Approved
Date submitted
30/10/2013
Date registered
12/11/2013
Date last updated
12/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Does neurofeedback enhance sleep?
Scientific title
Does neurofeedback in healthy individuals increase total sleep time.
Secondary ID [1] 283488 0
Nil
Universal Trial Number (UTN)
U1111-1149-1485
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 290405 0
Condition category
Condition code
Other 290796 290796 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Between pre- and post-measures, the participants will be trained in neurofeedback using the nexus II system to enhance band amplitudes within specific individualised brain frequency bins (neurofeedback). Sessions will be approximately 30 minutes in duration and administered one on one by a physiologist. We anticipate 15 standardised conditioning sessions conducted 5 per week as per previous neurofeedback studies.
Intervention code [1] 288196 0
Prevention
Comparator / control treatment
Sham Neurofeedback (randomised frequency condition)
The design of the control group will be identical to the experimental group however; will differ only in the brain frequency adjustments.
Where the experimental group will have to enhance specific frequency amplitudes throughout ALL conditioning sessions, the controls will be dedicated to a randomised frequency paradigm.
Control group
Placebo

Outcomes
Primary outcome [1] 290790 0
Total Sleep Time measured using polysomnography. There will be one familiarization night and one testing night.
Timepoint [1] 290790 0
pre-neurofeedback (baseline), post-neurofeedback (completion of neurofeedback sessions)
Primary outcome [2] 290791 0
Sleep onset latency measured using polysomnography. There will be one familiarization night and one testing night.
Timepoint [2] 290791 0
pre-neurofeedback (baseline), post-neurofeedback (completion of neurofeedback sessions)
Secondary outcome [1] 305290 0
Sleep efficiency using polysomnography. There will be one familiarization night and one testing night.
Timepoint [1] 305290 0
pre-neurofeedback (baseline), post-neurofeedback (completion of neurofeedback sessions)
Secondary outcome [2] 305291 0
Subjective sleep rating using a ordinal scale (very poor, poor, average, good, very good)
Timepoint [2] 305291 0
sleep rating based on pre- and post- intervention polysomnography monitored night.
Secondary outcome [3] 305292 0
% slow wave sleep of the sleep period time using polysomnography. There will be one familiarization night and one testing night.
Timepoint [3] 305292 0
pre-neurofeedback (baseline), post-neurofeedback (completion of neurofeedback sessions)
Secondary outcome [4] 305293 0
percent of rapid eye movement sleep of the sleep period time using polysomnography. There will be one familiarization night and one testing night.
Timepoint [4] 305293 0
pre-neurofeedback (baseline), post-neurofeedback (completion of neurofeedback sessions)

Eligibility
Key inclusion criteria
Sleep onset greater than 30 minutes, sleep maintenance problems or sleep complaints more than 3/per week reported from the participant
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
shift workers, pregnancy at all stages, parents with newborns, presence of primary sleep disorders, consumption of more than 5 x caffeine beverages a day, phase delayed or phase advanced syndrome.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Due to the recruitment of participants for the current study allocation by randomisation will be difficult to assure a balance between characteristic groups i.e. gender and age.
An acceptable alternative for treatment allocation is through utilising “minimisation”. This process will ensure balance between group’s (gender and age) in a smaller sample study. With minimisation the treatment allocated to the next participant enrolled in the trial depends (wholly or partly) on the characteristics of those participants already enrolled. The aim therefore is each allocation should minimise the imbalance across multiple factors.
Reference: Altman, D.G., & Bland, J.M. (2005). Treatment allocation by minimisation. BMJ, 330:843.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the minimisation procedure explained above, minimisation will be performed with the aid of a free software program “minim” which was advised in the referenced article. The use of the software will ensure adherence to the protocol as the trial progresses.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main hypothesis for the project is: Does an individualised neurofeedback protocol improve sleep in healthy individuals? To analyse this question a linear mixed model will be run for each of the baseline variables. The variables to be analysed are: total sleep time (TST), sleep onset latency (SOL), sleep efficiency (SE) and % of slow wave sleep (SWS) and rapid eye movement sleep (REM). The conditions tested: neurofeedback and control. Time points: Pre intervention and Post intervention. In addition to the linear mixed model baseline variables will be examined between the intervention group and the controls using an Independent Sample t-test to check for differences in sleep variables between both groups. Significance level will be set at p = 0.05.
The current sample size was selected based on power analysis (a=0.05,power=0.8,calculated sample size=15) using differences in total sleep time pre- and post- neurofeedback training in seventeen insomniacs (Cortoos et al. 2010)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2013
Actual
Date of last participant enrolment
Anticipated
30/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288189 0
Government body
Name [1] 288189 0
Australian Sports Commission
Country [1] 288189 0
Australia
Primary sponsor type
Government body
Name
Australian Sports Commission
Address
POBox 176 Belconnen ACT 2617
Country
Australia
Secondary sponsor category [1] 286914 0
None
Name [1] 286914 0
Address [1] 286914 0
Country [1] 286914 0
Other collaborator category [1] 277674 0
University
Name [1] 277674 0
Murdoch University
Address [1] 277674 0
90 South St, Murdoch WA 6150
Country [1] 277674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290099 0
Australian Institute of Sport Ethics Committee
Ethics committee address [1] 290099 0
Ethics committee country [1] 290099 0
Australia
Date submitted for ethics approval [1] 290099 0
30/07/2013
Approval date [1] 290099 0
14/08/2013
Ethics approval number [1] 290099 0
20130803
Ethics committee name [2] 290100 0
Murdoch University Human Ethics Committe
Ethics committee address [2] 290100 0
Ethics committee country [2] 290100 0
Australia
Date submitted for ethics approval [2] 290100 0
16/09/2013
Approval date [2] 290100 0
03/10/2013
Ethics approval number [2] 290100 0
2013/175

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43970 0
Miss Laura Juliff
Address 43970 0
POBox 176 Belconnen ACT 2617
Country 43970 0
Australia
Phone 43970 0
+61 02 62147869
Fax 43970 0
Email 43970 0
laura.juliff@ausport.gov.au
Contact person for public queries
Name 43971 0
Laura Juliff
Address 43971 0
POBox 176 Belconnen ACT 2617
Country 43971 0
Australia
Phone 43971 0
+61 02 62147869
Fax 43971 0
Email 43971 0
laura.juliff@ausport.gov.au
Contact person for scientific queries
Name 43972 0
Laura Juliff
Address 43972 0
POBox 176 Belconnen ACT 2617
Country 43972 0
Australia
Phone 43972 0
+61 02 62147869
Fax 43972 0
Email 43972 0
laura.juliff@ausport.gov.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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