Validation of a Wireless, Self-Applied Device for Sleep Recording in the Paediatric Population

Antonella Iadarola1, Ramona Cordani1,2, Marco Veneruso1,2

  • 1Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy.

Nature and Science of Sleep
|November 10, 2025
PubMed

Insights

The Sleep Profiler (SP) is a reliable ambulatory device for pediatric sleep studies, showing good agreement with polysomnography (PSG). Manual scoring of SP data is accurate, but automatic scoring needs improvement for clinical use.

Area of Science:

  • Sleep Medicine
  • Pediatric Sleep Evaluation
  • Ambulatory Monitoring

Background:

  • Polysomnography (PSG) is the gold standard for sleep studies but faces compliance and setup challenges in children.
  • Ambulatory sleep monitoring devices offer a potential solution to overcome limitations of traditional PSG in pediatric populations.
  • The Sleep Profiler (SP) is a self-applied ambulatory PSG device previously validated in adults.

Purpose of the Study:

  • To evaluate the reliability and accuracy of the Sleep Profiler (SP) in a pediatric population for the first time.
  • To compare SP recordings with standard PSG in adolescents aged 11-15 years.
  • To assess both manual and automatic scoring of SP data against expert-scored PSG.

Main Methods:

  • Simultaneous standard PSG and SP recordings were obtained from 14 hospitalized pediatric patients.
  • Recordings were independently scored by two certified sleep medicine experts blinded to patient identity.
  • Agreement was assessed using confusion matrices and Cohen's kappa coefficient (κ), with PSG as the reference; sleep macrostructure was analyzed using Bland-Altman plots.

Main Results:

  • Manual scoring of SP data (SP1) demonstrated substantial agreement with standard PSG (κ > 0.80 for REM, wake, and N3 sleep).
  • Automatic scoring algorithms (AA1, AA2) showed markedly lower agreement (κ < 0.70).
  • SP1 exhibited high specificity (>96%) for most sleep stages and good sensitivity (>84% for most stages), with minimal bias in sleep macrostructure parameters.

Conclusions:

  • The Sleep Profiler (SP) is a reliable tool for sleep monitoring in pediatric populations, overcoming compliance and setup issues.
  • Manual scoring of SP data is accurate, but automatic scoring requires further refinement for clinical application.
  • The SP's robust detection of REM and N3 sleep makes it suitable for clinical and research use in children and adolescents.
Abstract