Impact of Orthopedic Surgery on Workers' Sleep

NCT06854913 | Enrolling By Invitation

• 2 other identifiers: 270.24 CET2 cbmPNC0000007 - CUP: B53C22006980
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Musculoskeletal disorders; Shoulder pain; Sleep Monitoring; Orthopedic Surgery Outcomes; Wearable Sensors

Outcome Measures

Primary Outcomes (6)

• Heart Rate Evaluation During Sleep Across Different Rehabilitation Phases

  Heart rate will be monitored using wearable sensors during sleep across different rehabilitation phases. It will be recorded in beats per minute to evaluate the physiological response to recovery and adaptation throughout the rehabilitation process.

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

• Respiratory Rate Evaluation Evaluation During Sleep Across Different Rehabilitation Phases

  Respiratory rate will be monitored using wearable sensors during sleep across different rehabilitation phases. It will be recorded in breaths per minute to assess the physiological response to recovery and adaptation throughout the rehabilitation process

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

• Change in Sleep Efficiency Across Different Rehabilitation Phases

  Sleep efficiency is defined as the percentage of total sleep time (TST) relative to the total time spent in bed (sleep opportunity). It is calculated by dividing the amount of time spent asleep by the total time in bed and multiplying by 100. This measurement will be obtained using wearable sensors. Values of 85% or higher are generally considered indicative of good sleep quality. This parameter is critical for assessing how effectively the available time for sleep is used and for identifying sleep fragmentation or disruptions.

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

• Change in Sleep Duration Across Different Rehabilitation Phases

  Sleep duration refers to the total amount of time a subject spends asleep during the night, expressed in minutes or hours. It is measured from the onset of sleep until the final awakening, excluding periods of wakefulness. The wearable device continuously tracks sleep and wake states, providing an accurate account of total sleep time. For adults, a duration of 7 to 9 hours is typically recommended. Monitoring sleep duration is essential to evaluate the restorative quality of sleep and to compare changes across different rehabilitation phases.

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

• Change in Wake After Sleep Onset (WASO) Across Different Rehabilitation Phases

  WASO is defined as the total time, in minutes, that a subject remains awake after the initial onset of sleep and before the final awakening. A wearable device records all episodes of wakefulness during the sleep period and sums them to calculate WASO. A WASO value of less than 30 minutes is generally considered normal for healthy sleep. Elevated WASO values can indicate increased sleep fragmentation, which may compromise the quality of sleep.

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

• Change in Sleep Latency Across Different Rehabilitation Phases

  Sleep latency is the duration, measured in minutes, between the moment a subject goes to bed (or turns off the lights) and the onset of sleep. The wearable device identifies the sleep onset as the first epoch classified as sleep. A sleep latency of less than 20 minutes is generally considered normal, whereas prolonged sleep latency may signal difficulties in initiating sleep, possibly due to pre-surgical anxiety or post-surgical discomfort.

  three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase)

Secondary Outcomes (4)

• Change in Sleep Data among different rehabilitation phases

  Three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase).

• Evaluation of the usability and Comfort of Wearable Technology

  Three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase).

• Evaluation of the Objective Improvement in Shoulder Functionality

  Three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase).

• Evaluation of the Reduction in Pain Levels among different rehabilitation phases

  Three key time points: before surgery (baseline), two weeks after surgery (early recovery phase), and 30 days post-surgery (mid-recovery phase).

Study Arms (1)

Workers with shoulder musculoskeletal disorders

EXPERIMENTAL

Workers with shoulder musculoskeletal disorders will be enrolled from the Unit of Traumatology and Sports Medicine of FPUCBM. Patients who meet the inclusion criteria will be provided with an explanation of the study and the experimental protocol. After consenting to participate in the study and signing the informed consent, demographic and anthropometric data will be collected and registered on a database shared among authorized investigators involved in the project. In addition, patients will receive detailed verbal and written instructions on how to use the Medtronic Zephyr BioPatch™ wearable biosensor (Medtronic, Inc., Annapolis, MD, USA) for sleep monitoring. They will also be trained on how to complete the Consensus Sleep Diary, which they will fill out each morning after using the sensor. Sleep monitoring will be conducted at three key time points to assess changes in sleep patterns during the study. The first assessment will occur over two consecutive nights prior to surgery,

Other: Post-Operative monitoring using wearable biosensor; Other: Usability Assessment and Patient Willingness to Use Technology Description

Interventions

Post-Operative monitoring using wearable biosensor OTHER

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.

Workers with shoulder musculoskeletal disorders

Usability Assessment and Patient Willingness to Use Technology Description OTHER

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.

Workers with shoulder musculoskeletal disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained.
• Age ≥ 18 years.
• Good understanding of spoken and written Italian.
• Diagnosis of shoulder musculoskeletal disorders.
• Employment in a physically demanding job requiring frequent upper limb activity.
• Workers scheduled to undergo orthopedic shoulder surgery.
• Workers who have accepted the surgical treatment.

You may not qualify if:

• Patients with sleep disorders.
• Patients undergoing pharmacological treatments that could potentially affect sleep patterns (e.g., antidepressants, hypnotics, and stimulants).
• Failure to sign informed consent.
• Patients with neuromuscular diseases.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 3, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)