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SlumberCurve™ Sleep Aid for Rotator Cuff Surgery Recovery

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

Study Summary

This trial will test a new sleep aid, SlumberCurve, to see if it improves sleep quality and pain management following rotator cuff surgery.

Who is the study for?

This trial is for adults over 18 with a full-thickness rotator cuff tear scheduled for repair surgery. It's not suitable for those on workers' comp, with irreparable tears, severe shoulder arthritis, sleep apnea or other sleep disorders, neuropsychiatric conditions, prior shoulder surgeries, or acute fractures in the shoulder area.Check my eligibility

What is being tested?

The study tests SlumberCurve™, an adjustable wedge pillow designed to enhance sleep quality and alleviate night-time pain after rotator cuff repair. Participants will be randomly assigned to use this novel sleep aid to see if it offers significant benefits post-surgery.See study design

What are the potential side effects?

While specific side effects are not detailed for SlumberCurve™ as it's a non-pharmaceutical intervention, potential discomforts may include difficulty adjusting to the pillow shape or issues related to sleeping posture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with a severe shoulder injury needing surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fitbit Sleep Data - Sleep Stages

Fitbit Sleep Data - Time spent awake, restless, and asleep

Pittsburgh Sleep Quality Index (PSQI)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Slumber Curve GroupExperimental Treatment1 Intervention

Patients receiving Slumber Curve sleep aid for management of pain and sleep quality following rotator cuff repair.

Group II: Normal Sleep Routine GroupActive Control1 Intervention

Patients not receiving sleep aid.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,277,979 Total Patients Enrolled

1 Trials studying Rotator Cuff Tears

130 Patients Enrolled for Rotator Cuff Tears

Eight28, LLCUNKNOWN

Media Library

Slumber Curve sleep aid Clinical Trial Eligibility Overview. Trial Name: NCT04774965 — N/A

Rotator Cuff Tears Research Study Groups: Slumber Curve Group, Normal Sleep Routine Group

Rotator Cuff Tears Clinical Trial 2023: Slumber Curve sleep aid Highlights & Side Effects. Trial Name: NCT04774965 — N/A

Slumber Curve sleep aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04774965 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for individuals to enroll in this research endeavor?

"As per clinicaltrials.gov, the study is no longer recruiting volunteers and was initially posted on June 30th 2024 with a final update occurring on June 29th 2022. Despite this trial being inactive, 824 other studies are presently taking patients into consideration."

Answered by AI

Does this clinical trial extend to individuals aged fifty-five and above?

"The parameters for inclusion in this study are adults aged 18 to 99. Furthermore, there is a distinct cohort of 105 trials targeting minors and 679 experiments that predominately involve patients over 65 years old."

Answered by AI

Am I eligible to join the research project?

"In order to be accepted into this clinical trial, patient must demonstrate pain symptoms and have undergone a prior operation. Those who fit the criteria also need to between 18-99 years old in order for their application to be considered; with 50 slots available overall."

Answered by AI