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Not yet recruitingNCT06625723Updated Nov 18, 2024

Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

An interventional study of Standard postoperative care and Surgical Recovery Systems Sleep Aid in Rotator Cuff Tears, Rotator Cuff Injuries and Shoulder Pain, sponsored by New York Presbyterian Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.

Sponsored by New York Presbyterian Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rotator Cuff Tears
  • Rotator Cuff Injuries
  • Shoulder Pain
  • Shoulder Injuries
  • Shoulder Impingement
03

In context

Rotator Cuff Injuries

631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

New York Presbyterian Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Rotator Cuff Tear

Exclusion criteria

Exclusion Criteria:

  • Prior ipsilateral shoulder surgery
  • Ipsilateral upper extremity neurological deficit
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Standard postoperative care for patients undergoing rotator cuff repair.

    Procedure: Standard postoperative care

  • Experimental
    Sleep Aid Group

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

    Procedure: Standard postoperative care · Device: Surgical Recovery Systems Sleep Aid

Interventions

  • ProcedureStandard postoperative care

    This will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.

  • DeviceSurgical Recovery Systems Sleep Aid

    Sleep assistive device

06

What researchers measure

Primary outcomes

  1. Narcotic Use

    Total amount of daily narcotics consumed for pain control.

    Time frame: Daily

  2. Patient Reported Sleep Quality

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

    Time frame: 3 months

Secondary outcomes

  1. Sleep Data

    Objective metrics collected via wearable sleep tracker - heart rate measured in BPM

    Time frame: 3 months

  2. Sleep Data

    Objective metrics collected via wearable sleep tracker - heart rate variability measured in ms

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06625723
Lead sponsor
New York Presbyterian Hospital
Responsible party
Cole Morrissette (Resident Orthopedic Surgeon, New York Presbyterian Hospital) — Principal investigator
First posted
Oct 3, 2024
Start date
Dec 1, 2024 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Nov 18, 2024

Study contacts

Cole Morrissette, MD
Contact
crm2224@cumc.columbia.edu
3322153690

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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