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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Insomnia

Separation anxiety

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Anxiety

Neurological

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]

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]

Change in the Separation Anxiety scale of the Spence Children’s Anxiety Scale - Child version (SCAS-C)

Timepoint [1]

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]

Change in polysomnography measured REM arousal index

Timepoint [2]

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]

Change in sleep onset latency, as assessed using the 7-day sleep diary

Timepoint [1]

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]

Change in daytime sleepiness, assessed using the Pediatric Daytime Sleepiness Scale (PDSS)

Timepoint [2]

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]

Change in the levels of reported daytime worries, as assessed using the Worry Scale for Children (WSC)

Timepoint [3]

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]

Change in wake after sleep onset, as assessed using the 7-day sleep diary

Timepoint [4]

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]

Change in the number of awakenings, as assessed using the 7-day sleep diary

Timepoint [5]

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]

Change in total sleep time, as assessed using the 7-day sleep diary

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

GPO Box 2100
Adelaide SA 5001

Country [1]

Australia

Primary sponsor type

University

Name

Flinders University

Address

GPO Box 2100
Adelaide SA 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee, Flinders University

Ethics committee address [1]

Sturt Road, Bedford Park, South Australia, 5042
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/04/2021

Approval date [1]

19/04/2021

Ethics approval number [1]

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

Prof Michael Gradisar

Address

College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+61 8 82012324

Fax

[email protected]

Contact person for public queries

Name

Michael Gradisar

Address

College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+61 8 82012324

Fax

[email protected]

Contact person for scientific queries

Name

Michael Gradisar

Address

College of Education, Psychology and Social Work
Flinders University
GPO Box 2100
Adelaide SA 5001

Country

Australia

Phone

+61 8 82012324

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
12702	Informed consent form					382492-(Uploaded-29-07-2021-09-45-26)-Study-related document.docx
12705	Ethical 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.

Trial Review

Documents added manually

Documents added automatically