Impact of Orthopedic Surgery on Workers' Sleep

Summary

Goal: The clinical investigation aims to evaluate the impact of orthopedic shoulder surgery on sleep quality and functional recovery in workers with shoulder musculoskeletal disorders. This will be assessed through validated questionnaires and physiological monitoring using wearable sensors.

Participant Population: The study will enroll at least 30 participants diagnosed with shoulder musculoskeletal disorders, such as rotator cuff tears, adhesive capsulitis, and glenohumeral osteoarthritis. Participants must be employed in physically demanding jobs that require frequent upper limb activity and are scheduled for orthopedic shoulder surgery.

Main Questions:

* How does post-operative rehabilitation influence sleep quality and functional recovery in workers with shoulder musculoskeletal disorders?
* To what extent does post-operative rehabilitation improve pain management and overall quality of life in these patients?
* How do patients perceive the usability and comfort of wearable sensors during their rehabilitation process?

Participant Tasks:

* Initial Assessment: Comprehensive clinical evaluation, including demographic and anthropometric data collection, and administration of the Pittsburgh Sleep Quality Index (PSQI).
* Wearable Sensor Training: Instruction on the proper use of the Medtronic Zephyr BioPatch™ wearable biosensor for monitoring physiological and postural signals.
* Sleep Monitoring: Participants will undergo sleep assessments at three key time points: Two nights before surgery (baseline measurement); Two weeks post-surgery during early rehabilitation; 30 days into the rehabilitation program.
* Daily Logging: Completion of the Consensus Sleep Diary each morning following sensor use.
* Functional Assessment: Objective evaluation of shoulder functionality through validated clinical scales and range of motion (ROM) assessments.
* Pain and Usability Evaluation: Measurement of pain reduction and usability of wearable technology using Patient-Reported Outcome Measures (PROMs).

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico

  lead OTHER

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-03

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Italy

Study Locations