Skip to main content
Clinical Trials/NCT06625723
NCT06625723Not yet recruitingNot Applicable

Investigating the Impact of a Sleep Aid on Sleep and Recovery Following Rotator Cuff Repair Surgery

New York Presbyterian Hospital0 sites60 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
Narcotic Use

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Rotator Cuff Tear

Exclusion Criteria

  • Prior ipsilateral shoulder surgery
  • Ipsilateral upper extremity neurological deficit

Arms & Interventions

Control Group

Active Comparator

Standard postoperative care for patients undergoing rotator cuff repair.

Intervention: Standard postoperative care (Procedure)

Sleep Aid Group

Experimental

Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.

Intervention: Standard postoperative care (Procedure)

Sleep Aid Group

Experimental

Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.

Intervention: Surgical Recovery Systems Sleep Aid (Device)

Outcomes

Primary Outcomes

Narcotic Use

Time Frame: Daily

Total amount of daily narcotics consumed for pain control.

Patient Reported Sleep Quality

Time Frame: 3 months

Using questionnaire to evaluate patient satisfaction with sleep and associated symptoms. Scale will be subjective 1-10

Secondary Outcomes

  • Sleep Data(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cole Morrissette

Resident Orthopedic Surgeon

New York Presbyterian Hospital

Similar Trials