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Not yet recruiting NCT07582081

Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

Observational Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Shoulder. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Correlation Between Objective Sleep Parameters and Clinical Outcome Scores [Time frame: 6 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara City Hospital — Ankara

Publications

  • 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

Identifiers

NCT: NCT07582081 · RSA-SLEEP-2026-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗