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Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty (Sleep and RSA)

A

Ankara City Hospital

Status

Begins enrollment in 1 month

Conditions

Shoulder

Study type

Observational

Funder types

Other

Identifiers

NCT07582081
RSA-SLEEP-2026-05

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

20 participants in 1 patient group

RSA
Description:
RSA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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