Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

ConditionsInsomnia Postoperative Delirium Delayed Neurocognitive Recovery Postoperative Neurocognitive Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorMassachusetts General Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)
Behavioral
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.
Sleep Health Education
Behavioral
Sleep Health Education materials provided

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Digital CBT-IExperimental treatment 1 intervention

Group B: Sleep Health EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

Adherence: CBT-I

A Patient Adherence Form developed by the Veterans Affairs CBT-I Training Program will be used to assess adherence to the protocol. A mean adherence score across six domains showing good psychometric properties will be derived (0-24; higher represents more adherent)

Time frame

After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.

Adherence: Sleep Diary/Actigraphy

The number of days of completed sleep diaries and actigraphy will be recorded.

Time frame

Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery.

Adherence: Homework Completion

The amount of time spent on CBT-I homework will be recorded.

Time frame

After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery.

Insomnia Severity

The Insomnia Severity Index (ISI) questionnaire will be used to determine the quality of sleep for patients (0 to 28; higher represents more severe insomnia symptoms)

Time frame

At screening, baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery

Secondary outcomes

Sleep Quality

The Pittsburgh Sleep Quality Index (PSQI) questionnaire will be used to assess subjective sleep quality in patients (range 0 to 21; higher scores indicate worse sleep quality).

Time frame

At baseline, every session of the dCBT-I/control 3-week intervention period, 2 weeks, 1- and 3-months after surgery

Utility

A 16-item digital intervention utility questionnaire will be used to assess patient usage of the app (0-64; higher represents more perceived utility)

Time frame

After dCBT-I intervention during Review session ~1 day to 1 week before surgery.

Satisfaction with intervention

A 9-item survey will be used to assess which elements of the app were most helpful and the likelihood the patient would recommend it to family/friends.

Time frame

After dCBT-I intervention during Review session ~1 days to 1 week before surgery.

Cognition

Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition

Time frame

At baseline and 2 weeks, 1- and 3-months after surgery

Other outcomes

Circadian Rest-Activity Rhythms

Motor activity will be recorded on wrist actigraphy watches to derive amplitude, acrophase, interdaily stability, intradaily variability, most active 10h (M10), least active 5h (L5), relative amplitude (RA), fractal motor activity regulation (FMAR).

Time frame

At baseline, immediately after the intervention, and 2 weeks, 1- and 3-months after surgery

Ancillary Data Collection

Collection of blood samples from participant

Time frame

Before baseline session, on surgery day, and once on post-operative days 1-3