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NCT Number: NCT07582081

Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

This prospective blinded study aims to investigate the relationship between objectively measured sleep parameters and patient-reported sleep and functional outcomes in patients undergoing reverse shoulder arthroplasty. Sleep will be assessed using MotionWatch 8, and outcomes will be correlated with validated clinical scores. This study is designed as a prospective, blinded clinical investigation conducted at a single tertiary referral center. Patients undergoing reverse shoulder arthroplasty for cuff arthropathy or glenohumeral osteoarthritis will be consecutively enrolled.

Objective sleep parameters will be collected using MotionWatch 8 one week prior to surgery in the patients' home environment. Functional and subjective sleep assessments will be performed preoperatively using validated scoring systems including ASES, Constant-Murley Score, VAS, SST, PSQI, and Jenkins Sleep Scale.

Postoperative follow-up will include reassessment of functional scores at 1, 3, and 6 months. At the 6-month follow-up, both subjective sleep assessments and objective sleep measurements will be repeated.

The primary objective is to evaluate the correlation between objective sleep parameters and ASES and PSQI scores.

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Key information

Conditions

Shoulder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing reverse shoulder arthroplasty Diagnosis of cuff arthropathy or glenohumeral osteoarthritis Age ≥18 years Ability to provide informed consent

Exclusion criteria

Refusal to participate Known psychiatric disorders Pre-existing diagnosed sleep disorders or ongoing treatment for sleep disturbances Pathology affecting the contralateral shoulder Inability to comply with study protocol

Treatment and study plan

Primary outcomes

  1. Correlation Between Objective Sleep Parameters and Clinical Outcome Scores

    Time frame: 6 months postoperatively

    The primary outcome is the strength of association between objective sleep parameters measured by actigraphy (MotionWatch 8), including total sleep time, sleep efficiency, sleep latency, and nocturnal activity, and patient-reported outcome measures, specifically the American Shoulder and Elbow Surgeons (ASES) score and Pittsburgh Sleep Quality Index (PSQI).

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Correlation Between Objective Sleep Parameters Measured by MotionWatch 8 and Functional Outcomes in Patients Undergoing Reverse Shoulder Arthroplasty: A Prospective Blinded Study

Acronym: Sleep and RSA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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