Clinical Trial

Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

Study acronym: Sleep and RSA
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07582081
Lead Sponsor Ankara City Hospital Bilkent
Conditions Shoulder
Enrollment 20 participants
Start Date 2026-07-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12