Sleep and Functional Outcomes After Reverse Shoulder Arthroplasty (Sleep and RSA)
Correlation Between Objective Sleep Parameters Measured by MotionWatch 8 and Functional Outcomes in Patients Undergoing Reverse Shoulder Arthroplasty: A Prospective Blinded Study
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Çankaya
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Ankara, Çankaya, Tyrkiet (Türkiye), 06660
- Ankara City Hospital
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Kontakt:
- Yavuz Şahbat, MD
- Telefonnummer: +90 542 619 34 77
- E-mail: yavuzsahbat@gmail.com
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Kontakt:
- Serhat Akçaalan, MD, Assoc. Prof.
- Telefonnummer: +90 542 671 12 67
- E-mail: akcaalanserhat@gmail.com
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Ledende efterforsker:
- Ceyhun Çağlar, MD, Assoc. Prof.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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RSA
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Correlation Between Objective Sleep Parameters and Clinical Outcome Scores
Tidsramme: 6 months postoperatively
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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).
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6 months postoperatively
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RSA-SLEEP-2026-05
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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