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Positional Therapy with LEFT Device for Acid Reflux

N/A

Waitlist Available

Led By Abdulfatah Issak, MD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

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

Must have

Patients over the age of 18 who have proven GERD (with nighttime heartburn at least 3 days a week)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trial will enroll 120 GERD patients who will be randomly assigned to either the intervention group or the control group. The intervention group will be asked to use the LEFT device for four weeks while the control group will be given general lifestyle and dietary recommendations.

Who is the study for?

This trial is for adults over 18 with proven GERD who experience nighttime heartburn at least three times a week. Participants must be able to read and complete questionnaires, have a compatible mobile phone, and agree to sleep positioning therapy using the LEFT device.Check my eligibility

What is being tested?

The study tests the LEFT device, an electronic wearable that trains patients to sleep on their left side using gentle vibrations. It aims to reduce nocturnal acid reflux symptoms in GERD patients by encouraging a specific sleeping position.See study design

What are the potential side effects?

Since the LEFT device uses noninvasive positional therapy through vibration, it's expected to have minimal side effects compared to medical treatments. However, discomfort from wearing the device or disturbances due to vibrations could occur.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 and have GERD with frequent nighttime heartburn.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms as measured by GERD symptoms checklist (questionnaire, involves no specific units of measure).

Secondary outcome measures

The of the study is to determine if positional therapy improves quality of sleep and health-related quality of life as measured by Epworth Sleepiness, Scale and Sleep quality, SF-36 and Berlin questionnaires. No units of measure.