Analysis of Sleep & Recovery Following Rotator Cuff Repair Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNew York Presbyterian Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Rotator Cuff Tear
Disqualifiers
Prior ipsilateral shoulder surgery
Ipsilateral upper extremity neurological deficit
Trial design
Design model
Parallel
Treatments tested in this trial
Standard postoperative care
Procedure/SurgeryThis will include medications, rehabilitation schedules, and follow-up visits as normally scheduled.
Surgical Recovery Systems Sleep Aid
DeviceSleep assistive device
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Sleep Aid GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Narcotic Use
Total amount of daily narcotics consumed for pain control.
Time frame
Daily2
Patient Reported Sleep Quality
Using questionnaire to evaluate patient satisfaction with sleep and associated symptoms. Scale will be subjective 1-10
Time frame
3 monthsSecondary outcomes
1
Sleep Data
Objective metrics collected via wearable sleep tracker - heart rate measured in BPM
Time frame
3 months2
Sleep Data
Objective metrics collected via wearable sleep tracker - heart rate variability measured in ms
Time frame
3 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: