Recruiting

Digital Sleep Optimization

Sponsor:

Massachusetts General Hospital

Code:

NCT06375265

Conditions

Insomnia

Postoperative Delirium

Delayed Neurocognitive Recovery

Postoperative Neurocognitive Disorder

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

Sleep Health Education

Study Details

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

Study ID

NCT06375265

Start date

Jan 15, 2025

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults ≥ 65 years old
2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip)
3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)

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

Exclusion Criteria:

1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study
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)
8. 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)
9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Digital CBT-I

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.

active comparator: Sleep Health Education

Preoperative sleep health education materials

Interventions

digital Cognitive Behavioral Therapy for Insomnia (dCBT-I)

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

Sleep Health Education materials provided

Primary outcome measure

  • Adherence: CBT-I [ Time Frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. ]
  • Adherence: Sleep Diary/Actigraphy [ Time Frame: Throughout the study 3-4 weeks before surgery, and 2 weeks, 1 month and 3 months after surgery. ]
  • Adherence: Homework Completion [ Time Frame: After dCBT-I intervention during Review session ~1 day to 3 weeks before surgery. ]
  • 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 ]

Central Contacts and Locations

Central contacts

Andrea Castillo, BS

4695094163acastillo17@mgh.harvard.edu

Elesha McGrath, BS

718-541-7957mjimenezgallardo@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Lei Gao, MD

6178882941lgao@mgh.harvard.edu

Andrea Castillo, BS

4695094163acastillo17@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.