Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001409369
Ethics application status
Approved
Date submitted
28/09/2017
Date registered
5/10/2017
Date last updated
13/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of disordered sleep and anxiety in primary school-aged children
Scientific title
Can Sleep Restriction Therapy account for changes in anxiety via REM sleep continuity in school aged children with Chronic Insomnia Disorder?
Secondary ID [1] 292942 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Insomnia Disorder 304838 0
Anxiety 304839 0
Condition category
Condition code
Mental Health 304140 304140 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment condition will receive Sleep Restriction Therapy based on principles of Cognitive Behaviour Therapy for Insomnia. Treatment will be provided by a Psychologist, Clinical Psychologist, or Provisional Psychologist at the Child and Adolescent Sleep Clinic (Flinders University). Sleep Restriction Therapy involves reducing time-in-bed to 30 minutes less than the usual average total sleep time. This will be achieved by shifting the child's usual bed time later by 30 minutes. Child participants and their parent/guardian will attend two therapy sessions (one week apart, 1 hour on each occasion) and will implement their given schedule for a period of two weeks. Adherence to the intervention will be monitored using a 7-day sleep diary and wrist actigraphy
Intervention code [1] 299185 0
Behaviour
Intervention code [2] 299289 0
Treatment: Other
Comparator / control treatment
Control participants will undergo Bedtime Regularisation. Child participants and their parent/guardian will attend two therapy sessions (one week apart, 1 hour on each occasion). Treatment will be provided by a Psychologist, Clinical Psychologist, or Provisional Psychologist. Participants will receive psycho-education (e.g., information about sleep architecture, REM sleep, circadian rhythms) and implement a regular and consistent bedtime schedule. This will be achieved by calculating their average time-in-bed across the baseline week, and then planning a schedule that involves being in bed for that amount of time each night (using a bed time and rise time that works for their household). This schedule will be implemented for a period of two weeks. Adherence to the planned sleep schedule will be monitored using a 7-day sleep diary and wrist actigraphy.
Control group
Active

Outcomes
Primary outcome [1] 303474 0
Change in child-rated total anxiety scale (Spence Children's Anxiety Scale)
Timepoint [1] 303474 0
Baseline: 7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [1] 339033 0
Change in number of arousals from REM sleep (as measured by overnight polysomnography recording)
Timepoint [1] 339033 0
Baseline: 1 night recording prior to commencement of intervention
Post-treatment: 1 night recording post completion of intervention
Secondary outcome [2] 339034 0
Change in sleep efficiency score (based on sleep parameters from sleep diary e.g., time in bed, sleep onset latency, total sleep time, time awake after sleep onset)
Timepoint [2] 339034 0
Baseline: 7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7 days post commencement of intervention (assessed over a 7-day period)

Eligibility
Key inclusion criteria
Meet diagnostic criteria for Behavioural Insomnia of Childhood according to the International Classification of Sleep Disorders -2 manual
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atypical development, English as a second language, non-psychological sleep disorders (e.g., sleep disordered breathing, parasomnias), diagnosed co-morbid sleep disorder,

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)
Allocation involved contacting the holder of the allocation schedule after the initial assessment was undertaken (to assess eligibility).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model regressions (LMMRs) will be used to assess if the self-reported anxiety scores of children in the treatment group show a greater reduction compared to children in the control group (interaction effect). LMMRs will also be used to assess for greater changes in REM sleep for the treatment group compared to the controls (interaction effect for more continuous REM sleep in the treatment condition).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/03/2017
Date of last participant enrolment
Anticipated
11/06/2018
Actual
2/05/2018
Date of last data collection
Anticipated
29/06/2018
Actual
24/05/2018
Sample size
Target
30
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 297568 0
University
Name [1] 297568 0
Flinders University
Country [1] 297568 0
Australia
Primary sponsor type
Individual
Name
Prof Michael Gradisar
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 296579 0
None
Name [1] 296579 0
Address [1] 296579 0
Country [1] 296579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298663 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 298663 0
Ethics committee country [1] 298663 0
Australia
Date submitted for ethics approval [1] 298663 0
14/02/2017
Approval date [1] 298663 0
20/02/2017
Ethics approval number [1] 298663 0
38.14

Summary
Brief summary
This study aims to determine whether changes in REM sleep stability (during treatment for insomnia) can account for reductions in anxiety in primary school-aged children. Compared to children in the control group, we expect children in the treatment group to show improvements in sleep, anxiety and REM sleep stability..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77814 0
Miss Emma Hunt
Address 77814 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 77814 0
Australia
Phone 77814 0
+61882012324
Fax 77814 0
Email 77814 0
[email protected]
Contact person for public queries
Name 77815 0
Miss Emma Hunt
Address 77815 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 77815 0
Australia
Phone 77815 0
+61882012324
Fax 77815 0
Email 77815 0
[email protected]
Contact person for scientific queries
Name 77816 0
Miss Emma Hunt
Address 77816 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 77816 0
Australia
Phone 77816 0
+61882012324
Fax 77816 0
Email 77816 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.