Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 16, 2024

Keywords

ClinConnect Summary

The SLEEP-BOOST clinical trial is investigating a new approach to help older patients improve their sleep before and after undergoing major orthopedic surgeries, like knee or hip replacements. This study aims to see if a special mobile app, designed to help with insomnia, can work better when combined with a wearable device that tracks sleep patterns. The goal is to find out if better sleep can lead to improved brain health and reduce issues like confusion after surgery.

To participate in this study, you need to be at least 65 years old, scheduled for a joint replacement surgery, and have some trouble sleeping, indicated by a specific screening score. You'll also need to have a smartphone and be comfortable using the app and device. If you join, you can expect to follow the app's guidance to improve your sleep, which may help your recovery after surgery. It's important to note that certain medical conditions or previous treatments for insomnia might prevent someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults ≥ 65 years old
• • 2. Scheduled for an elective orthopedic total joint replacement procedure (knee/hip) with an anticipated stay of ≥48 hours
• • 3. At least mild insomnia (ISI score of ≥10 on telephone screening)
• • 4. Stable sleep-affecting medications in the prior month (by clinical review)
• • 5. Own a smart phone
• • 6. Willingness to use the dCBT-I app and actigraphy.
• Exclusion Criteria:
• • 1. Current or previous CBT-I
• • 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)