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NCT Number: NCT06625723

Analysis of Sleep & 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.

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Key information

Conditions

Rotator Cuff Tears Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Impingement Shoulder Impingement Syndrome Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rotator Cuff Tear

Exclusion criteria

  • Prior ipsilateral shoulder surgery
  • Ipsilateral upper extremity neurological deficit

Treatment and study plan

Standard postoperative care

Procedure

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

Surgical Recovery Systems Sleep Aid

Device

Sleep assistive device

Primary outcomes

  1. Narcotic Use

    Time frame: Daily

    Total amount of daily narcotics consumed for pain control.

  2. 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

Secondary outcomes

  1. Sleep Data

    Time frame: 3 months

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

  2. Sleep Data

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cole Morrissette, MD

CONTACT

[email protected]

3322153690

Sponsors and collaborators

Lead sponsor

New York Presbyterian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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