Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07582081

Acronym

Sleep and RSA

Enrollment

Registered

2026-05-12

Start date

2026-07-01

Completion date

2027-07-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder

Keywords

RSA, Sleep quality

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Turkey (Türkiye)

Outcome results