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

Mass General Brigham

Status: Enrolling

Conditions: Delayed Neurocognitive Recovery; Postoperative Neurocognitive Disorder; Insomnia; Postoperative Delirium

Treatments: Behavioral: Sleep Health Education; Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT06375265

2024P000780-1

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Digital CBT-I

Experimental group

Description:

Preoperative digital CBT-I with the CBT-I Coach app for up to 4 weekly sessions and postoperative booster sessions at 2 weeks and 1 month after surgery.

Treatment:

Behavioral: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Sleep Health Education

Active Comparator group

Description:

Preoperative sleep health education materials

Treatment:

Behavioral: Sleep Health Education