Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06625723

Enrollment

Registered

2024-10-03

Start date

2024-12-01

Completion date

2027-04-01

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain, Shoulder Injuries, Shoulder Impingement

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Two treatment arms, one standard postoperative protocol following rotator cuff repair surgery. The second arm with the same protocol, with the addition of the sleep assistive device.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Rotator Cuff Tear

Exclusion criteria

* Prior ipsilateral shoulder surgery * Ipsilateral upper extremity neurological deficit

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Sleep Data	3 months	Objective metrics collected via wearable sleep tracker - heart rate measured in BPM

Contacts

Primary ContactCole Morrissette, MD

crm2224@cumc.columbia.edu3322153690

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026