Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty
ConditionShoulder
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAnkara City Hospital Bilkent
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: RSA
Trial outcomes
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).
Time frame
6 months postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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