Pediatric Insomnia
Task Force

Establishing Core Outcome Sets (COS) for Pediatric Insomnia

Pediatric insomnia is among the most prevalent sleep disorders in childhood and adolescence, affecting an estimated 20–30% of children across all developmental stages. Despite its significant burden on child health, family functioning, and long-term neurodevelopmental outcomes, clinical research in this area is fragmented by substantial heterogeneity in how outcomes are defined, measured, and reported. This inconsistency limits the ability to compare and synthesize evidence across trials, undermines systematic reviews and meta-analyses, and ultimately delays the translation of research into effective clinical practice.

Primary Objective

To develop an internationally endorsed Core Outcome Set (COS) for use in clinical trials and research studies of pediatric insomnia (ages 0–18 years), through a transparent, multi-stakeholder consensus process aligned with COMET methodology.

Secondary Objectives

  1. To conduct a systematic review of outcomes reported in pediatric insomnia studies and identify gaps and inconsistencies in current measurement practices.
  2. To identify and categorise outcomes of importance across key stakeholder groups, including children and adolescents, parents and caregivers, clinicians, researchers, and other relevant stakeholders.
  3. To achieve international consensus on a minimum set of core outcomes through a structured Delphi survey process.
  4. To recommend feasible, age-appropriate, and validated approaches to outcome measurement for each core domain.
  5. To disseminate the Core Outcome Set and promote its adoption through IPSA and wider clinical, research, and policy networks.