Support for better sleep in children with neurodevelopmental disorders
Can a Supportive Sleep-Practitioner-led Intervention Lead to Improved Sleep, Wellbeing and Reduced Medication Prescribing for Children With Neurodevelopmental Disorders and Co-occurring Severe Sleep Difficulties?
This study is testing a new approach to help children aged 4-11 with neurodevelopmental disorders improve their sleep without using medication like melatonin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 4 Years to 11 Years |
| Sex | All |
| Sponsor | Sheffield Children's NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield) |
| Trial ID | NCT05971212 on ClinicalTrials.gov |
What this trial studies
This study aims to address sleep disturbances in children aged 4-11 with neurodevelopmental disorders such as ADHD and autism. It will provide access to a behavioral sleep clinic, focusing on teaching sleep hygiene and behavioral modification techniques to improve sleep quality without relying on medication like melatonin. The study will include 76 children who have been experiencing severe sleep disturbances and have been on melatonin for over a year. By evaluating the effectiveness of these non-pharmacological interventions, the study seeks to offer long-term strategies for better sleep management.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-11 with a formal diagnosis of ADHD, autism, or another neurodevelopmental condition who have severe sleep disturbances.
Not a fit: Patients who have already accessed a sleep clinic or do not speak English as their first language may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for children with neurodevelopmental disorders.
How similar studies have performed: Previous studies have shown that behavioral sleep interventions can be effective for children with similar conditions, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children to be included will fulfil all of the inclusion criteria. * Formal diagnosis of ADHD, autism or another neurodevelopmental condition, * Age 4-11 years, * Severe sleep disturbance (defined as Score of 3 or more on Composite Sleep Disturbance Index), * Been taking melatonin to aid sleep onset for more than 12 months Exclusion Criteria: * Exclusion Criteria * Already accessed a sleep clinic at Sheffield Children's Hospital or The Sleep Charity. * English not first language
Where this trial is running
Sheffield
- Clinical Research Facility, Sheffield Children's Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Heather Elphick
- Email: h.elphick@nhs.net
- Phone: 01142 717000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.