INTRODUCTION: Postoperative neurocognitive disorders, including delirium and longer-term cognitive decline, are among the most common and costly complications of surgery in older adults, yet effective preventive strategies remain limited. Insomnia and sleep-circadian disruption are highly prevalent in this population, affecting up to one-third of older adults undergoing elective surgery and represent potentially modifiable risk factors that are rarely addressed in perioperative care. Cognitive Behavioural Therapy for Insomnia (CBT-I) is the first-line, evidence-based treatment for insomnia; however, its feasibility and efficacy have not been systematically evaluated for perioperative implementation. This protocol describes a pilot randomised controlled trial designed to evaluate the feasibility and acceptability of a condensed CBT-I intervention in the perioperative setting. The study will also explore its potential effects on insomnia and postoperative outcomes.
METHODS: The SLEEP-BOOST study is a single-site, randomised controlled pilot trial conducted at Massachusetts General Hospital. The study will enrol 50 older adults (≥65 years) undergoing elective orthopaedic surgery with insomnia symptoms (Insomnia Severity Index≥10). Participants will be randomised 1:1 to either a condensed CBT-I intervention or a patient contact-matched Sleep Hygiene Education control group. All participants will complete 3 weeks of preoperative actigraphy and daily sleep diaries, with follow-up assessments at 2 weeks, 1 month and 3 months after surgery. The primary outcome is feasibility, assessed through adherence metrics, protocol engagement and acceptability. Secondary outcomes will be treated as exploratory including insomnia severity, sleep quality, actigraphy-derived sleep and circadian metrics, cognitive trajectories, postoperative pain, mood, functional status and incidence of postoperative neurocognitive disorders.
ETHICS AND DISSEMINATION: This protocol has received ethics approval from Massachusetts General Hospital Institutional Review Board (Protocol #2024P000780). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant sleep treatment organisations. Participants will receive a summary of the study results.
TRIAL REGISTRATION NUMBER: NCT06375265.
