Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery
November 14, 2024 updated by: Cole Morrissette, New York Presbyterian Hospital
Investigating the Impact of a Sleep Aid on Sleep and Recovery Following Rotator Cuff Repair Surgery
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cole Morrissette, MD
- Phone Number: 3322153690
- Email: crm2224@cumc.columbia.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Rotator Cuff Tear
Exclusion Criteria:
- Prior ipsilateral shoulder surgery
- Ipsilateral upper extremity neurological deficit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Standard postoperative care for patients undergoing rotator cuff repair.
|
This will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.
|
|
Experimental: Sleep Aid Group
Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively.
|
This will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.
Sleep assistive device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Narcotic Use
Time Frame: Daily
|
Total amount of daily narcotics consumed for pain control.
|
Daily
|
|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Data
Time Frame: 3 months
|
Objective metrics collected via wearable sleep tracker - heart rate measured in BPM
|
3 months
|
|
Sleep Data
Time Frame: 3 months
|
Objective metrics collected via wearable sleep tracker - heart rate variability measured in ms
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
August 27, 2024
First Submitted That Met QC Criteria
October 1, 2024
First Posted (Actual)
October 3, 2024
Study Record Updates
Last Update Posted (Estimated)
November 18, 2024
Last Update Submitted That Met QC Criteria
November 14, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Joint Diseases
- Rupture
- Tendon Injuries
- Arthralgia
- Rotator Cuff Injuries
- Shoulder Injuries
- Wounds and Injuries
- Shoulder Pain
- Shoulder Impingement Syndrome
- Sleep Aids, Pharmaceutical
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antiemetics
- Autonomic Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Dermatologic Agents
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Histamine Antagonists
- Histamine Agents
- Neurotransmitter Agents
- Hypnotics and Sedatives
- Anti-Allergic Agents
- Antipruritics
- Histamine H1 Antagonists
- Diphenhydramine
- Promethazine
Other Study ID Numbers
- ColumbiaOrthopedics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.