Clinical trial NCT06375265: Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients
Official title: A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Postoperative Delirium
Delayed Neurocognitive Recovery
Postoperative Neurocognitive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
3. At least mild insomnia (ISI score of ≥10 on telephone screening)
4. Stable sleep-affecting medications in the prior month (by clinical review)
5. Own a smart phone
6. Willingness to use the dCBT-I app and actigraphy.

Exclusion Criteria:

1. Current or previous CBT-I
2. Rapidly progressive illnesses/life expectancy \<6 months
3. Active psychosis/suicidal ideation
4. Irregular shift work/sleep patterns
5. Moderate-severe sleep apnea (apnea/hypopnea index ≥15) without CPAP compliance per chart review
6. Sleep disorders other than insomnia or apnea
7. Cognitive impairment (diagnosis of dementia)

Primary outcomes:
measure: Adherence
timeFrame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
measure: Insomnia Severity
timeFrame: At screening, baseline, during dCBT-I/control, 2 weeks, 1- and 3-months after surgery
Secondary outcomes:
measure: Sleep Diary Completion
timeFrame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.
measure: Homework Completion
timeFrame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.
measure: Utility
timeFrame: After dCBT-I intervention during Review session ~1 day to 1 week before surgery.
measure: Satisfaction with intervention
timeFrame: After dCBT-I intervention during Review session ~1 days to 1 week before surgery.
measure: Cognition
timeFrame: At baseline and 2 weeks, 1- and 3-months after surgery
measure: Pain severity
timeFrame: At baseline and 2 weeks, 1- and 3-months after surgery
measure: Mood
timeFrame: At baseline and 1- and 3-months after surgery
measure: Anxiety
timeFrame: At baseline and 1- and 3-months after surgery
measure: Function
timeFrame: At baseline and 2 weeks, 1- and 3-months after surgery
measure: Postoperative Delirium Incidence
timeFrame: From postoperative day 1 to postoperative day 3
measure: Postoperative Delirium Severity
timeFrame: From postoperative day 1 to postoperative day 3
measure: Delayed Neurocognitive Recovery
timeFrame: At 1-months after surgery
measure: Postoperative Neurocognitive Disorders (NCD)
timeFrame: At 3-months after surgery
measure: Sleep Efficiency
timeFrame: At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery
Other outcomes:
measure: Circadian Rest-Activity Rhythms
timeFrame: At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass. General Hospital
name: Lei Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: