Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001116819
Ethics application status
Approved
Date submitted
29/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of REM sleep fragmentation in treatment for insomnia and separation anxiety
Scientific title
Links between REM sleep fragmentation, insomnia, and separation anxiety: Evidence from a randomized controlled trial comparing sleep restriction therapy and bedtime regularization in children aged 7 to 13 years
Secondary ID [1] 304903 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Insomnia 323032 0
Separation anxiety 323033 0
Condition category
Condition code
Mental Health 320596 320596 0 0
Other mental health disorders
Mental Health 320597 320597 0 0
Anxiety
Neurological 320825 320825 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep Restriction Therapy will be provided to participants in the treatment group. This treatment is based on principles of Cognitive Behaviour Therapy for Insomnia, and will be provided by a clinical or provisional psychologist at the Flinders Child and Adolescent Sleep Clinic. 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 bedtime 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. The first therapy session will include the following: (1) psychoeducation about sleep architecture, sleep hygiene, and sleep homeostatic pressure; and (2) an explanation about Sleep Restriction Therapy, and a detailed plan for implementing it (i.e., specifying the child’s new sleep schedule). Sleep schedule changes will be implemented immediately after the first therapy session. Families will be asked to complete a sleep diary through the following week to monitor adherence to the intervention. The second session will include a review of the past week, and any necessary amendments to the sleep schedule (e.g., if the family reports heightened daytime sleepiness, the sleep opportunity may be extended by 15 mins).
Intervention code [1] 321293 0
Behaviour
Comparator / control treatment
The control group will receive Bedtime Regularisation Therapy, provided by a clinical or provisional psychologist at the Flinders Child and Adolescent Sleep Clinic. Child participants and their parent/guardian will attend two therapy sessions (one week apart, 1 hour on each occasion). Participants will receive psychoeducation (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. This schedule will be implemented for a period of two weeks, starting immediately after the first therapy session. Families will be asked to complete a sleep diary to monitor their adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 328416 0
Change in the Separation Anxiety scale of the Spence Children’s Anxiety Scale - Child version (SCAS-C)
Timepoint [1] 328416 0
Baseline: 7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 14 days post commencement of intervention (assessed over a 7-day period)
Primary outcome [2] 328417 0
Change in polysomnography measured REM arousal index
Timepoint [2] 328417 0
Baseline: 1 day prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [1] 398944 0
Change in sleep onset latency, as assessed using the 7-day sleep diary
Timepoint [1] 398944 0
Baseline: 0-7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7-14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [2] 398946 0
Change in daytime sleepiness, assessed using the Pediatric Daytime Sleepiness Scale (PDSS)
Timepoint [2] 398946 0
Baseline: 7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [3] 398947 0
Change in the levels of reported daytime worries, as assessed using the Worry Scale for Children (WSC)
Timepoint [3] 398947 0
Baseline: 7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [4] 399732 0
Change in wake after sleep onset, as assessed using the 7-day sleep diary
Timepoint [4] 399732 0
Baseline: 0-7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7-14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [5] 399733 0
Change in the number of awakenings, as assessed using the 7-day sleep diary
Timepoint [5] 399733 0
Baseline: 0-7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7-14 days post commencement of intervention (assessed over a 7-day period)
Secondary outcome [6] 399734 0
Change in total sleep time, as assessed using the 7-day sleep diary
Timepoint [6] 399734 0
Baseline: 0-7 days prior to commencement of intervention (assessed over a 7-day period)
Post-treatment: 7-14 days post commencement of intervention (assessed over a 7-day period)

Eligibility
Key inclusion criteria
Children will be eligible if they meet diagnostic criteria for Behavioural Insomnia of Childhood according to the International Classification of Sleep Disorders 3rd edition manual (ICSD-3), and have a score of >3 on the Separation Anxiety subscale of the SCAS.
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Atypical development, non-psychological sleep disorders (e.g., sleep disordered breathing, parasomnias), and 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 will involve contacting the holder of the allocation schedule who was "off-site" or at central administration site.
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 modeling will be used to test whether self-reported separation anxiety scores of participants in the treatment group show a greater reduction from baseline to post-treatment compared to children in the control group. These models will also be used to assess for greater changes in REM sleep fragmentation, reported sleep metrics, daytime sleepiness, and worry scores in the treatment compared to the control group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/2021
Date of last participant enrolment
Anticipated
31/05/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
40
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 309276 0
University
Name [1] 309276 0
Flinders University
Country [1] 309276 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 310247 0
None
Name [1] 310247 0
Address [1] 310247 0
Country [1] 310247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309115 0
Human Research Ethics Committee, Flinders University
Ethics committee address [1] 309115 0
Sturt Road, Bedford Park, South Australia, 5042
Australia
Ethics committee country [1] 309115 0
Australia
Date submitted for ethics approval [1] 309115 0
04/04/2021
Approval date [1] 309115 0
19/04/2021
Ethics approval number [1] 309115 0
4236

Summary
Brief summary
This research project seeks to answer the following research questions:
1) Is there a relationship between separation anxiety and REM sleep fragmentation in children in middle childhood (aged 7-13) with insomnia?
2) Can Sleep Restriction Therapy reduce separation anxiety, sleep fragmentation, REM sleep fragmentation, daytime sleepiness, and worrying in these children?
The study will randomly allocate children to receive either Sleep Restriction Therapy or Bedtime Regularisation. Children’s separation anxiety, sleep, sleepiness, and worries will be assessed using self-report measures as well as polysomnography at baseline and post-treatment.
We hypothesize that separation anxiety will be significantly associated with REM sleep fragmentation. We also expect to observe greater reductions in anxiety, REM fragmentation, sleep fragmentation, and sleepiness from baseline to post-treatment in children receiving Sleep Restriction Therapy compared to Bedtime Regularisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113026 0
Prof Michael Gradisar
Address 113026 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 113026 0
Australia
Phone 113026 0
+61 8 82012324
Fax 113026 0
Email 113026 0
[email protected]
Contact person for public queries
Name 113027 0
Prof Michael Gradisar
Address 113027 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 113027 0
Australia
Phone 113027 0
+61 8 82012324
Fax 113027 0
Email 113027 0
[email protected]
Contact person for scientific queries
Name 113028 0
Prof Michael Gradisar
Address 113028 0
College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 113028 0
Australia
Phone 113028 0
+61 8 82012324
Fax 113028 0
Email 113028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the clinical sensitivity of these data, they will not be publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12702Informed consent form    382492-(Uploaded-29-07-2021-09-45-26)-Study-related document.docx
12705Ethical approval    382492-(Uploaded-28-07-2021-15-02-01)-Study-related document.pdf



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.