Randomised trial of home sleep apnoea testing compared to in-lab polysomnography for the evaluation of obstructive...

Area of Science:

• Pediatric Sleep Medicine
• Diagnostic Accuracy Studies
• Clinical Trials

Background:

• Obstructive sleep apnoea (OSA) affects 1-5% of children, with higher prevalence (55-90%) in those with Down syndrome (DS).
• Current gold standard, in-lab polysomnography (PSG), presents significant burdens for families and limited accessibility.
• Home sleep apnoea testing (HSAT) is an accepted alternative for adults but requires more evidence for pediatric use, particularly for children with DS or sensory issues.

Purpose of the Study:

• To evaluate the diagnostic accuracy of HSAT compared to PSG for pediatric obstructive sleep apnoea (OSA).
• To assess the agreement between HSAT and PSG for guiding therapeutic decisions in children.
• To compare the preference and acceptability of HSAT versus PSG among pediatric patients and their families.

Main Methods:

• A single-center trial comparing HSAT with PSG for diagnosing OSA in children aged 5-12 years.
• Enrollment of 317 children, including approximately 100 with Down syndrome (DS).
• Primary outcome: diagnostic accuracy of HSAT versus PSG using Receiver Operating Characteristic (ROC) curves.

Main Results:

• The study is designed to determine the diagnostic accuracy of HSAT for pediatric OSA.
• It will also assess the concordance between HSAT and PSG for treatment decisions.
• Patient and family preferences and the acceptability of both testing methods will be compared.

Conclusions:

• HSAT presents a potentially valuable alternative to PSG for diagnosing pediatric OSA, especially for children with Down syndrome (DS).
• This research aims to provide evidence to support the broader clinical adoption of HSAT for pediatric OSA evaluation.
• Successful validation of HSAT could expand testing options, improving accessibility and reducing burdens for families.