Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

NCT06375265 | Recruiting

• 1 other identifier: 2024P000780-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Adherence

  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)

  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)

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

Secondary Outcomes (15)

• Sleep Diary Completion

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

• Sleep Quality

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

• Homework Completion

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

• Utility

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

• Satisfaction with intervention

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

Other Outcomes (1)

• Circadian Rest-Activity Rhythms

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

Study Arms (2)

Digital CBT-I

EXPERIMENTAL

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.

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

Sleep Health Education

ACTIVE COMPARATOR

Preoperative sleep health education materials

Behavioral: Sleep Health Education

Interventions

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.

Digital CBT-I

Sleep Health Education BEHAVIORAL

Sleep Health Education materials provided

Sleep Health Education

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Starting sleep-affecting medications less than a month prior to starting study or at any time during the study 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Emergence Delirium

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Study Officials

• Lei Gao, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Castillo, BS

CONTACT

4695094163; acastillo17@mgh.harvard.edu

Mili Jimenez Gallardo

CONTACT

mjimenezgallardo@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 19, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)