Rotator Cuff TearsNCT06625723
Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery
A study testing Standard postoperative care and Surgical Recovery Systems Sleep Aid in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by New York Presbyterian Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain
- What is being tested?
- Standard postoperative care and Surgical Recovery Systems Sleep Aid
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator Cuff Tear
Who cannot join
- Prior ipsilateral shoulder surgery
- Ipsilateral upper extremity neurological deficit
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain, Shoulder Injuries, Shoulder Impingement
- Being tested
- Standard postoperative care, Surgical Recovery Systems Sleep Aid
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Pain, Shoulder Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard postoperative careProcedure or surgery
This will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.
Surgical Recovery Systems Sleep AidDevice
Sleep assistive device
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard postoperative care for patients undergoing rotator cuff repair. Receives: Procedure: Standard postoperative care |
| Sleep Aid Group | Experimental | Standard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively. Receives: Procedure: Standard postoperative care; Device: Surgical Recovery Systems Sleep Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Use
Total amount of daily narcotics consumed for pain control.
Measured: Daily
Patient Reported Sleep Quality
Using questionnaire to evaluate patient satisfaction with sleep and associated symptoms. Scale will be subjective 1-10
Measured: 3 months
Secondary outcomes (2)
Sleep Data
Objective metrics collected via wearable sleep tracker - heart rate measured in BPM
Measured: 3 months
Sleep Data
Objective metrics collected via wearable sleep tracker - heart rate variability measured in ms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cole Morrissette, New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625723
- Sponsor's protocol ID
- ColumbiaOrthopedics
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of a Sleep Aid on Sleep and Recovery Following Rotator Cuff Repair Surgery
- ClinicalTrials.gov ID
- NCT06625723
- Acronym / sponsor ID
- ColumbiaOrthopedics
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Pain, Shoulder Injuries, Shoulder Impingement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Standard postoperative careStandard postoperative care for patients undergoing rotator cuff repair. |
| Sleep Aid Group | Experimental | Procedure: Standard postoperative care, Device: Surgical Recovery Systems Sleep AidStandard postoperative care for patients undergoing rotator cuff repair PLUS the use of the sleep assistive device postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rotator Cuff Tear
Key exclusion criteria (2 listed)
- Prior ipsilateral shoulder surgery
- Ipsilateral upper extremity neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard postoperative careThis will include medications, rehabilitation schedules, and follow-up visits as normally scheduled. | Procedure or surgery | Control Group, Sleep Aid Group |
| Surgical Recovery Systems Sleep AidSleep assistive device | Device | Sleep Aid Group |
Primary outcome
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
2 secondary outcomes
Sleep Data
Time frame: 3 months
Sleep Data
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Standard postoperative care and Surgical Recovery Systems Sleep Aid in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by New York Presbyterian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cole Morrissette, MD (3322153690, crm2224@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Use (time frame: Daily). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.