The Effects of SlumberCurve™ Following Rotator Cuff Surgery: A Randomized Control Trial

Studies

Study First Submitted Date 2021-02-24
Study First Posted Date 2021-03-01
Last Update Posted Date 2023-07-07
Start Month Year June 30, 2024
Primary Completion Month Year December 31, 2024
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-07

Detailed Descriptions

Sequence: 20775056
Description Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. These anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. Therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. A recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. This study hopes to address this gap in the literature by investigating a novel sleep aid, SlumberCurve, and its effect on sleep quality and night-time pain relief. SlumberCurve is a Class I Medical Device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. The device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. This novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.

Facilities

Sequence: 200551228
Name UAB Hospital Highlands
City Birmingham
State Alabama
Zip 35205
Country United States

Browse Interventions

Sequence: 96267508 Sequence: 96267509 Sequence: 96267510 Sequence: 96267511 Sequence: 96267512 Sequence: 96267513 Sequence: 96267514 Sequence: 96267515 Sequence: 96267516 Sequence: 96267517 Sequence: 96267518 Sequence: 96267519 Sequence: 96267520 Sequence: 96267521 Sequence: 96267522 Sequence: 96267523 Sequence: 96267524 Sequence: 96267525 Sequence: 96267526 Sequence: 96267527 Sequence: 96267528
Mesh Term Diphenhydramine Mesh Term Promethazine Mesh Term Sleep Aids, Pharmaceutical Mesh Term Hypnotics and Sedatives Mesh Term Central Nervous System Depressants Mesh Term Physiological Effects of Drugs Mesh Term Anesthetics, Local Mesh Term Anesthetics Mesh Term Sensory System Agents Mesh Term Peripheral Nervous System Agents Mesh Term Antiemetics Mesh Term Autonomic Agents Mesh Term Gastrointestinal Agents Mesh Term Histamine H1 Antagonists Mesh Term Histamine Antagonists Mesh Term Histamine Agents Mesh Term Neurotransmitter Agents Mesh Term Molecular Mechanisms of Pharmacological Action Mesh Term Anti-Allergic Agents Mesh Term Antipruritics Mesh Term Dermatologic Agents
Downcase Mesh Term diphenhydramine Downcase Mesh Term promethazine Downcase Mesh Term sleep aids, pharmaceutical Downcase Mesh Term hypnotics and sedatives Downcase Mesh Term central nervous system depressants Downcase Mesh Term physiological effects of drugs Downcase Mesh Term anesthetics, local Downcase Mesh Term anesthetics Downcase Mesh Term sensory system agents Downcase Mesh Term peripheral nervous system agents Downcase Mesh Term antiemetics Downcase Mesh Term autonomic agents Downcase Mesh Term gastrointestinal agents Downcase Mesh Term histamine h1 antagonists Downcase Mesh Term histamine antagonists Downcase Mesh Term histamine agents Downcase Mesh Term neurotransmitter agents Downcase Mesh Term molecular mechanisms of pharmacological action Downcase Mesh Term anti-allergic agents Downcase Mesh Term antipruritics Downcase Mesh Term dermatologic agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52307732 Sequence: 52307733 Sequence: 52307734
Name Rotator Cuff Tears Name Surgery Name Pain, Postoperative
Downcase Name rotator cuff tears Downcase Name surgery Downcase Name pain, postoperative

Id Information

Sequence: 40256714
Id Source org_study_id
Id Value IRB-300006834

Countries

Sequence: 42675602
Name United States
Removed False

Design Groups

Sequence: 55745810 Sequence: 55745811
Group Type Experimental Group Type No Intervention
Title Slumber Curve Group Title Normal Sleep Routine Group
Description Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair. Description Patients not receiving sleep aid.

Interventions

Sequence: 52619528
Intervention Type Device
Name Slumber Curve sleep aid
Description Patients who undergo rotator cuff repair and have been consented and randomized to the experimental group will be given a Slumber Curve sleep aid to be used during sleep. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Slumber Curve, patients will be given instructions on how to use the sleep aid while sleeping, and will be asked to use Slumber Curve nightly.

Design Outcomes

Sequence: 177883475 Sequence: 177883476 Sequence: 177883477 Sequence: 177883478 Sequence: 177883479 Sequence: 177883480 Sequence: 177883481
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary
Measure Fitbit Sleep Data – Time spent awake, restless, and asleep Measure Fitbit Sleep Data – Sleep Stages Measure Pittsburgh Sleep Quality Index (PSQI) Measure Visual Analog Scale (VAS) Measure Single Assessment Numeric Evaluation (SANE) Measure Postoperative Oral Morphine Equivalents Measure Simple Shoulder Test (SST)
Time Frame 90 days Time Frame 90 days Time Frame 90 days Time Frame 90 days Time Frame 90 days Time Frame 90 days Time Frame 90 days
Description Estimates of time spent awake, restless, and asleep will be assessed. All three measures will be recorded in minutes. Restless sleep indicates movement, and excessive movement will indicates time spent awake. Description Sleep stages are estimated by utilizing movement and heart rate variability. Sleep stages are categorized into light sleep, deep sleep, and REM. Collective time spent in each stage will be recorded in minutes. Description The PSQI tracks sleep disturbances over time and includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medications, and daytime dysfunction. Total of 21 points. Scores of less than 5 indicate adequate sleep. Scores of greater than 5 indicate poor sleep. Description Pain score, 0-10, 10 is best outcome Description Function score, 0-100%, 100% is best outcome Description Oral morphine equivalents of all opioid-containing medications received Description Function score. Higher score indicates greater function.

Browse Conditions

Sequence: 194008495 Sequence: 194008496 Sequence: 194008497 Sequence: 194008498 Sequence: 194008500 Sequence: 194008501 Sequence: 194008502 Sequence: 194008503 Sequence: 194008504 Sequence: 194008499
Mesh Term Pain, Postoperative Mesh Term Rotator Cuff Injuries Mesh Term Postoperative Complications Mesh Term Pathologic Processes Mesh Term Neurologic Manifestations Mesh Term Rupture Mesh Term Wounds and Injuries Mesh Term Shoulder Injuries Mesh Term Tendon Injuries Mesh Term Pain
Downcase Mesh Term pain, postoperative Downcase Mesh Term rotator cuff injuries Downcase Mesh Term postoperative complications Downcase Mesh Term pathologic processes Downcase Mesh Term neurologic manifestations Downcase Mesh Term rupture Downcase Mesh Term wounds and injuries Downcase Mesh Term shoulder injuries Downcase Mesh Term tendon injuries Downcase Mesh Term pain
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48447428 Sequence: 48447429
Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name University of Alabama at Birmingham Name Eight28, LLC

Central Contacts

Sequence: 12042240
Contact Type primary
Name Kyle D Paul, BS
Phone 2053329804
Email kylepaul@uab.edu
Role Contact

Design Group Interventions

Sequence: 68333843
Design Group Id 55745810
Intervention Id 52619528

Eligibilities

Sequence: 30844732
Gender All
Minimum Age 18 Years
Maximum Age 99 Years
Healthy Volunteers No
Criteria Inclusion Criteria: • Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery Exclusion Criteria: Patients who receive workers' compensation benefits Patients with irreparable tears Patients undergoing revision surgery Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis Sleep apnea disorder or other diagnosed sleep disorder Neuropsychiatric disease Use of sleep medication Prior shoulder surgery Rotator cuff arthropathy with pseudo paralysis Acute fractures involving the proximal humerus or shoulder girdle
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254197925
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Maximum Age Num 99
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 7

Designs

Sequence: 30590603
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28957052
Responsible Party Type Principal Investigator
Name Amit Momaya
Title Assistant Professor, Section Chief, Sports Medicine
Affiliation University of Alabama at Birmingham

Study References

Sequence: 52210256
Pmid 33447619
Reference Type background
Citation Kunze KN, Movasagghi K, Rossi DM, Polce EM, Cohn MR, Karhade AV, Chahla J. Systematic Review of Sleep Quality Before and After Arthroscopic Rotator Cuff Repair: Are Improvements Experienced and Maintained? Orthop J Sports Med. 2020 Dec 29;8(12):2325967120969224. doi: 10.1177/2325967120969224. eCollection 2020 Dec.