Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

Not Applicable

Not yet recruiting

• Conditions: Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries; Shoulder Impingement
• Interventions: Procedure: Standard postoperative care; Device: Surgical Recovery Systems Sleep Aid

• Registration Number: NCT06625723
• Lead Sponsor: New York Presbyterian Hospital

Brief Summary

Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Detailed Description

Postoperative recovery following a rotator cuff repair surgery can be challenging. In particular, sleeping is difficult given the restrictions of the operative shoulder. This study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Study Timeline

• Study First Submitted: 2024-08-27
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Study Start: 2024-12-01
• Primary Completion: 2026-10-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Rotator Cuff Tear

Exclusion Criteria

• Prior ipsilateral shoulder surgery
• Ipsilateral upper extremity neurological deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard postoperative care	Standard postoperative care for patients undergoing rotator cuff repair.
Sleep Aid Group	Standard postoperative care	Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.
Sleep Aid Group	Surgical Recovery Systems Sleep Aid	Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.

Primary Outcome Measures

Name	Time	Method
Narcotic Use	Daily	Total amount of daily narcotics consumed for pain control.
Patient Reported Sleep Quality	3 months	Using questionnaire to evaluate patient satisfaction with sleep and associated symptoms. Scale will be subjective 1-10

Secondary Outcome Measures

Name	Time	Method
Sleep Data	3 months	Objective metrics collected via wearable sleep tracker - heart rate variability measured in ms