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Sleep Support for Children With Neurodevelopmental Disorders

NCT05971212 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-08-02

No results posted yet for this study

Summary

Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both.

Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin. Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded.

In this feasibility study 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties will be recruited. The investigators will help to improve the child's sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed. Using this design, it will be possible to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children's Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.

Conditions

  • Sleep Hygiene
  • Sleep Wake Disorders

Interventions

BEHAVIORAL

Behavioural sleep clinic access

Access to behavioural Sleep Clinic

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Heather Elphick · Sheffield Children's NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971212 on ClinicalTrials.gov