Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

NCT07582081 | Not Yet Recruiting

• 1 other identifier: RSA-SLEEP-2026-05
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder

Keywords

RSA, Sleep quality

Outcome Measures

Primary Outcomes (1)

• Correlation Between Objective Sleep Parameters and Clinical Outcome Scores

  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).

  6 months postoperatively

Study Arms (1)

RSA

RSA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing reverse shoulder arthroplasty for cuff arthropathy or glenohumeral osteoarthritis at a single tertiary referral center will be included. All participants will be consecutively recruited and treated by the same experienced surgeon using a standardized surgical technique and implant system. The study population consists of patients without diagnosed sleep disorders or psychiatric conditions, who are able to complete patient-reported outcome measures and comply with home-based sleep monitoring using actigraphy (MotionWatch 8).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06660, Turkey (Türkiye)

Location

Related Publications (1)

• Kaymakoglu M, Kolac UC, Ayik G, Ibik S, Ozdemir E, Huri G. "Evaluation of sleep quality after reverse shoulder arthroplasty in rotator cuff tear arthropathy patients". Int Orthop. 2025 Dec;49(12):2851-2857. doi: 10.1007/s00264-025-06680-4. Epub 2025 Oct 25.

  PMID: 41137888 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)