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NCT Number: NCT06375265

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

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).

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Key information

Conditions

Insomnia Confusion Delayed Neurocognitive Recovery Delirium Dyssomnias Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Postoperative Neurocognitive Disorder Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Adherence: CBT-I

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

    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)

  2. Adherence: Sleep Diary/Actigraphy

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

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

  3. Adherence: Homework Completion

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

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

  4. Insomnia Severity

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

    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)

Secondary outcomes

  1. 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

    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).

  2. Utility

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

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

  3. Satisfaction with intervention

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

    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.

  4. Cognition

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

    Telephonic Montreal Cognitive Assessment (tMoCA) test to assess cognition

  5. Pain severity and Function

    Time frame: At baseline, end of the dCBTI/control intervention pre-surgery and 2 weeks, 1- and 3-months after surgery

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain will measure functional pain severity

  6. Mood/Anxiety

    Time frame: At baseline and 1- and 3-months after surgery

    The Geriatric Depression Scale-15 will be used to assess the mood of the patients (0-15; higher represents more severe mood/depression symptoms). Generalize Anxiety Disorder 7 (GAD-7; 0-21; higher represents more anxiety symptoms)

  7. Postoperative Delirium Incidence

    Time frame: From postoperative day 1 to postoperative day 3

    The Confusion Assessment Method (3D-CAM) will be used to monitor signs of delirium in patients.

  8. Postoperative Delirium Severity

    Time frame: From postoperative day 1 to postoperative day 3

    The Confusion Assessment Method (CAM)-Severity assessment will be used to monitor signs of delirium severity in patients.

  9. Delayed Neurocognitive Recovery

    Time frame: At 1-months after surgery

    Using cognitive change from baseline (1 standard deviation from the mean).

  10. Postoperative Neurocognitive Disorders (NCD)

    Time frame: At 3-months after surgery

    Using cognitive change from baseline (1 standard deviation from the mean).

Other outcomes

  1. Circadian Rest-Activity Rhythms

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

    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).

  2. Ancillary Data Collection

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

    Collection of blood samples from participant

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Castillo, BS

CONTACT

[email protected]

4695094163

Mili Jimenez Gallardo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SLEEP-BOOST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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