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Starting soon Observational

Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

NCT07582081 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-07-01
Last updated
2026-05-12

Condition(s) studied

Shoulder

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Correlation Between Objective Sleep Parameters and Clinical Outcome Scores — 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).

Trial sites (1)

FacilityCityRegionStatus
Ankara City Hospital Ankara Çankaya
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07582081 on ClinicalTrials.gov ↗ ← All trials in Turkey