Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Официальное название

A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)

Обзор

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Подробное описание

CBT-I is the frontline treatment for insomnia but is not considered for preoperative care of older surgical patients with insomnia who are at risk of perioperative neurocognitive disorders associated with sleep/circadian dysfunction. We propose to determine if digital CBT-I (dCBT-I) is feasible for treating older surgical patients with insomnia symptoms and to examine the effects of dCBT-I on sleep, cognitive trajectory, mood, pain, activity, and function after surgery. The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested CBT-I mobile application paired with a wearable device (wrist actigraphy).

Вмешательства

• Поведенческое digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
  Preoperative hybrid intervention (in-person or via phone/video) over 4 weeks, and at 2 weeks, and 1 month after surgery using content from the CBT-I Coach app from Veteran Affairs.
• Поведенческое Sleep Health Education
  Sleep Health Education materials provided

Первичные конечные точки

• Adherence: CBT-I [Срок оценки: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.]
• Adherence: Sleep Diary/Actigraphy [Срок оценки: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.]
• Adherence: Homework Completion [Срок оценки: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.]
• Insomnia Severity [Срок оценки: At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery]

Вторичные конечные точки (10)

• Sleep Quality [Срок оценки: At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery]
• Utility [Срок оценки: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.]
• Satisfaction with intervention [Срок оценки: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.]
• Cognition [Срок оценки: At baseline and 2 weeks, 1- and 3-months after surgery]
• Pain severity and Function [Срок оценки: At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery]
• Mood/Anxiety [Срок оценки: At baseline and 1- and 3-months after surgery]
• Postoperative Delirium Incidence [Срок оценки: From postoperative day 1 to postoperative day 3]
• Postoperative Delirium Severity [Срок оценки: From postoperative day 1 to postoperative day 3]
• Delayed Neurocognitive Recovery [Срок оценки: At 1-months after surgery]
• Postoperative Neurocognitive Disorders (NCD) [Срок оценки: At 3-months after surgery]

Критерии участия

Критерии включения

• Adults ≥ 65 years old
• Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
• At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)

5\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.

Критерии исключения

• Current or previous CBT-I exposure in the last 6 months prior to the start of the study
• Rapidly progressive illnesses/life expectancy <6 months
• Active psychosis/suicidal ideation
• Irregular shift work/sleep patterns
• Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
• Sleep disorders other than insomnia or apnea
• Cognitive impairment (diagnosis of dementia)
• Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review)
• No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Massachusetts General Hospital — Boston

Публикации

• Charles AE, Castillo Suarez AA, Chhajed M, Jimenez Gallardo M, Sanchez Valdes K, Li P, Hu K, Wong PM, Winkelman J, Gao L. Perioperative sleep optimisation and brain health in older adults (SLEEP-BOOST): protocol for a randomised controlled trial. BMJ Open. 2026 May 28;16(5):e116526. doi: 10.1136/bmjopen-2026-116526. PMID 42209013

Идентификаторы

NCT: NCT06375265 · 2024P000780-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗