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Behavioral Intervention

Digital CBT-I for Insomnia (SLEEP-BOOST Trial)

N/A

Waitlist Available

Led By Lei Gao, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours

Adults ≥ 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 1- and 3-months after surgery

Awards & highlights

SLEEP-BOOST Trial Summary

This trial aims to improve the sleep quality of older patients undergoing major joint surgery by using a mobile app and wearable device that have been previously tested for treating insomnia.

Who is the study for?

This trial is for older adults undergoing major joint surgery who may have sleep issues like insomnia or are at risk of postoperative cognitive complications. Participants should be willing to use a mobile app paired with a wearable device.Check my eligibility

What is being tested?

The study tests if digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) via an app, along with wearing a wrist device that tracks activity, can improve brain health outcomes after surgery compared to just receiving sleep health education.See study design

What are the potential side effects?

Since the interventions involve non-invasive therapy and education, side effects are minimal but could include discomfort from wearing the wrist device or stress from changing sleep habits.

SLEEP-BOOST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a knee or hip replacement and will stay in the hospital for at least 2 days.

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I am 65 years old or older.

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I have trouble sleeping, as confirmed by a test.

SLEEP-BOOST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 1- and 3-months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 1- and 3-months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 1- and 3-months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

Insomnia Severity

Secondary outcome measures

Anxiety

Cognition

Delayed Neurocognitive Recovery

+11 more

Other outcome measures

Circadian Rest-Activity Rhythms

SLEEP-BOOST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digital CBT-IExperimental Treatment1 Intervention

Preoperative digital CBT-I with the CBT-I Coach app and up to 4 weekly sessions

Group II: Sleep Health EducationActive Control1 Intervention

Preoperative sleep health education materials

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,198,673 Total Patients Enrolled

12 Trials studying Insomnia

822 Patients Enrolled for Insomnia

Lei Gao, MDPrincipal InvestigatorMass. General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Information available on clinicaltrials.gov indicates that recruitment for this particular trial is currently not ongoing. Despite being first posted on October 31, 2024 and having its latest update on April 16, 2024, the study is presently inactive in terms of patient enrollment. However, it's worth noting that there are a total of 291 active trials actively seeking participants at this time."

Answered by AI

What is the primary goal of this medical study?

"The primary aim of this clinical trial is to evaluate the impact of dCBT-I intervention on Insomnia Severity shortly before surgery, during a review session lasting approximately 3 days to 1 week. Secondary endpoints comprise assessing patient Satisfaction with the intervention through a comprehensive survey gauging app effectiveness and likelihood for recommendation to acquaintances or relatives, evaluating Cognition using the tMoCA test via telephone interaction, and monitoring Postoperative Neurocognitive Disorders (NCD) by measuring cognitive alterations from baseline data (equivalent to 1 standard deviation from the mean)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Lei Gao, MBBS, MMSc 2024. "Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06375265.