The SLEEP-BOOST study describes a protocol for a pilot randomised controlled trial evaluating the feasibility and acceptability of a condensed Cognitive Behavioural Therapy for Insomnia (CBT-I) intervention in the perioperative setting in older adults undergoing elective orthopaedic surgery.
Key Findings
Background
Insomnia and sleep-circadian disruption affect up to one-third of older adults undergoing elective surgery and represent potentially modifiable risk factors that are rarely addressed in perioperative care.
The prevalence of insomnia and sleep-circadian disruption is described as 'highly prevalent in this population, affecting up to one-third of older adults undergoing elective surgery'.
These conditions are identified as 'potentially modifiable risk factors' for postoperative neurocognitive disorders.
Despite their prevalence, these factors are 'rarely addressed in perioperative care'.
Background
Postoperative neurocognitive disorders, including delirium and longer-term cognitive decline, are described as among the most common and costly complications of surgery in older adults with limited preventive strategies.
Conditions include both delirium and 'longer-term cognitive decline'.
These disorders are characterized as 'among the most common and costly complications of surgery in older adults'.
'Effective preventive strategies remain limited' for these conditions.
Methods
The trial will enrol 50 older adults aged 65 years or older undergoing elective orthopaedic surgery who have insomnia symptoms, randomised 1:1 to a condensed CBT-I intervention or a Sleep Hygiene Education control group.
Sample size is 50 participants (n=25 per arm).
Inclusion requires an Insomnia Severity Index score of ≥10.
The study is a single-site pilot trial conducted at Massachusetts General Hospital.
The comparator is a 'patient contact-matched Sleep Hygiene Education control group'.
Methods
The primary outcome of the SLEEP-BOOST trial is feasibility, assessed through adherence metrics, protocol engagement and acceptability.
The study is explicitly designed as a pilot trial to evaluate 'feasibility and acceptability' of a condensed CBT-I intervention in the perioperative setting.
Feasibility is the primary endpoint, not clinical efficacy.
Secondary outcomes are 'treated as exploratory' given the pilot nature of the study.
Methods
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.
Preoperative monitoring includes actigraphy and daily sleep diaries for 3 weeks.
Follow-up assessment time points are 2 weeks, 1 month, and 3 months postoperatively.
Actigraphy-derived sleep and circadian metrics are among the secondary exploratory outcomes.
Methods
Secondary exploratory outcomes include insomnia severity, sleep quality, actigraphy-derived sleep and circadian metrics, cognitive trajectories, postoperative pain, mood, functional status and incidence of postoperative neurocognitive disorders.
Cognitive trajectories are included as a secondary exploratory outcome.
Incidence of postoperative neurocognitive disorders is captured as an exploratory endpoint.
Both subjective (insomnia severity, sleep quality, mood) and objective (actigraphy-derived) measures are included.
Postoperative pain and functional status are also assessed as exploratory outcomes.
Background
CBT-I is identified as the first-line, evidence-based treatment for insomnia, but its feasibility and efficacy have not been systematically evaluated for perioperative implementation.
CBT-I is described as 'the first-line, evidence-based treatment for insomnia'.
A 'condensed' version of CBT-I is being tested to fit the perioperative setting.
The protocol notes that CBT-I's 'feasibility and efficacy have not been systematically evaluated for perioperative implementation'.
The study received ethics approval from Massachusetts General Hospital Institutional Review Board (Protocol #2024P000780) and is registered as NCT06375265.
What This Means
This research describes the design of a small pilot clinical trial called SLEEP-BOOST, which will test whether a condensed form of Cognitive Behavioural Therapy for Insomnia (CBT-I) — a talking therapy that helps people develop better sleep habits and thoughts about sleep — can be practically delivered to older patients before and after surgery. The study targets adults aged 65 and over who are scheduled for elective orthopaedic surgery and who already have sleep problems. Half of the 50 participants will receive the CBT-I program, while the other half will receive basic sleep hygiene education as a comparison. The main question is not yet whether the therapy works, but whether it is feasible and acceptable to patients in this surgical context — meaning, will people actually engage with and complete the program around the time of their operation.
The motivation for the trial comes from evidence that poor sleep and disrupted body clocks are very common in older surgical patients — affecting up to one in three — and are linked to serious complications including delirium (sudden confusion) and longer-term memory and thinking problems after surgery. Despite this, sleep problems are rarely addressed as part of surgical care. CBT-I is already the recommended first-line treatment for insomnia in general populations, but it has never been formally tested in people preparing for surgery. Participants will wear wrist activity monitors and keep sleep diaries for three weeks before their operation, and will be followed up for three months after surgery with assessments of sleep, cognition, pain, mood, and everyday functioning.
This research suggests that if this condensed CBT-I approach proves feasible and acceptable in a pilot study, it could open the door to a larger trial testing whether improving sleep before and after surgery can reduce the risk of serious brain-related complications in older adults — a population for whom such complications are both common and potentially life-altering. The study is being conducted at Massachusetts General Hospital and results will be shared through scientific publications and public channels.
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Charles A, Castillo Suárez A, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, et al.. (2026). Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial.. BMJ open. https://doi.org/10.1136/bmjopen-2026-116526