Impact of Orthopedic Surgery on Workers' Sleep

NAEnrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Shoulder Musculoskeletal Disorders
Interventions
OTHER

Post-Operative monitoring using wearable biosensor

The protocol involves the use of the Medtronic Zephyr BioPatch™, a wearable biosensor, to monitor sleep quality and patterns in patients recovering from shoulder surgery. The device tracks physiological signals (ECG, HRV, respiratory rate) and postural changes, providing objective data on sleep profiles. Patients are assessed at three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase). The primary goal is to evaluate changes in sleep quality and patterns during the post-operative period, while also monitoring improvements in shoulder functionality and pain levels. This approach aims to provide insights into the relationship between sleep quality and recovery outcomes following shoulder surgery.

OTHER

Usability Assessment and Patient Willingness to Use Technology Description

The usability of the Medtronic Zephyr BioPatch™ is evaluated through patient feedback and questionnaires, focusing on comfort, ease of use, and reliability. Additionally, patient willingness to continue using the wearable sensor for sleep monitoring is assessed. This evaluation helps determine the practicality and acceptance of the technology in real-world rehabilitation settings, providing insights into its potential for long-term use in clinical practice.

Trial Locations (1)

00128

Fondazione Policlinico Universitario Campus Bio-Medico, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER