Evaluating a new treatment for sleep difficulties in children with autism spectrum disorder.

Not Applicable

Active, not recruiting

• Conditions: Sleep difficulties; Autism spectrum disorder; Mental Health - Autistic spectrum disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12623000757617
• Lead Sponsor: chenna Ezedinma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-11
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

i.Children aged 6-12 years with a valid diagnosis of ASD (level 2) and SD, and their primary caregivers,
ii.Meet the definition of sleep difficulties based on the clinical cut-off of >41 on the Children's Sleep Habits Questionnaire (CSHQ).
iii.Children who can complete pre-assessment EEG and polysomnography (level 2 home sleep study).

Exclusion Criteria

Co-diagnosis of congenital conditions such as Down syndrome.
ii. Child with a reported history of rTMS use.
iii. Child with diagnosed nocturnal seizures, blindness, and moderate-severe obstructive sleep apnoea (OSA).
iv. Child with body implants such as pacemaker, Defibrillator, Vagal Nerve Stimulator, VP Shunt/ Magnetic intracranial shunts, Deep Brain Stimulator, Epidural Cortical stimulator, Steel shunts/stents, Cranial metal fragments (i.e. shrapnel, excluding titanium), Cochlear implant, aneurysm clips, coils, pipelines flow diversion, magnetic dental implants, Implanted cardioverter defibrillators (ICD), and Ocular implants
v. Child that is still breast feeding.
vi. Child with primary brain cancer / metastatic legions in the brain (unless palliative care)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the difference in sleep quality and quantity following IAF-guided rTMS. This will be assessed as a composite outcome using actigraphy, polysomnography and the children's sleep habit questionnaire. [ At baseline, during the intervention (all day of the intervention), after intervention (the day following completion of the treatment program), and follow-up (one and four months posttreatment),]