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

March 14, 2025 updated by: Amit Momaya, University of Alabama at Birmingham
The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. The researchers hypothesize that SlumberCurve™ will significantly improve sleep quality and reduce night-time pain.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • UAB Hospital Highlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Slumber Curve Group
Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair.
Device: Slumber Curve sleep aid
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.
No Intervention: Normal Sleep Routine Group
Patients not receiving sleep aid.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fitbit Sleep Data - Time spent awake, restless, and asleep
Time Frame: 90 days
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.
90 days
Fitbit Sleep Data - Sleep Stages
Time Frame: 90 days
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.
90 days
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 90 days
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.
90 days
Visual Analog Scale (VAS)
Time Frame: 90 days
Pain score, 0-10, 10 is best outcome
90 days
Single Assessment Numeric Evaluation (SANE)
Time Frame: 90 days
Function score, 0-100%, 100% is best outcome
90 days
Postoperative Oral Morphine Equivalents
Time Frame: 90 days
Oral morphine equivalents of all opioid-containing medications received
90 days
Simple Shoulder Test (SST)
Time Frame: 90 days
Function score. Higher score indicates greater function.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eight28, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300006834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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