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The role of REM sleep fragmentation in treatment for insomnia and separation anxiety

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001116819
Enrollment
19
Registered
2021-08-23
Start date
2021-05-18
Completion date
2022-05-31
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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).

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
7 Years to 13 Years
Healthy volunteers
No

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.

Exclusion criteria

Atypical development, non-psychological sleep disorders (e.g., sleep disordered breathing, parasomnias), and diagnosed co-morbid sleep disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026