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 |
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. |