Positional Therapy with LEFT Device for Acid Reflux

Overseen By Ronnie Fass, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device called LEFT, designed to help people with nighttime acid reflux (GERD) by encouraging left-side sleeping. The device gently vibrates if it detects someone sleeping on their back or right side, potentially reducing heartburn and other reflux symptoms during sleep. This non-medical approach aims to improve sleep quality and lower the risk of complications linked to nocturnal GERD. Individuals with GERD who experience nighttime heartburn at least three times a week and are open to trying sleep positioning therapy might be suitable for the trial. Participants must have a compatible smartphone for the device. As an unphased trial, this study offers a unique opportunity to explore a non-medical solution for GERD symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on a nonmedical device for managing symptoms, it might not require changes to your medication regimen.

What prior data suggests that the LEFT device is safe for treating nocturnal GERD symptoms?

Research has shown that using the LEFT device for nighttime acid reflux might be safe. This device gently vibrates to encourage sleeping on the left side, which can reduce acid in the esophagus. Past studies have not provided direct data on serious side effects with the LEFT device.

However, similar devices, such as RefluxStop, have shown no serious side effects in follow-ups for up to a year. This suggests that these types of devices are generally well-tolerated. While specific safety data for the LEFT device is lacking, the success of similar technology offers some reassurance about its safety. Always consider personal health and consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LEFT Device for acid reflux because it offers a non-invasive, drug-free alternative to traditional treatments like proton pump inhibitors and H2 blockers. Unlike these standard medications, which work by reducing stomach acid production, the LEFT Device uses positional therapy to prevent acid from reaching the esophagus, potentially reducing symptoms without medication. This approach minimizes the risk of side effects commonly associated with long-term medication use, making it an appealing option for those seeking a more natural remedy for acid reflux.

What evidence suggests that the LEFT device is effective for nocturnal GERD?

Research has shown that sleeping on the left side can significantly reduce acid in the esophagus, easing nighttime symptoms of GERD, also known as acid reflux. Studies have found that this position can lower reflux episodes by 13-76%. Additionally, sleeping on the left side can reduce acid exposure in the esophagus by 87%, leading to fewer nighttime symptoms. In this trial, participants in the LEFT Device Arm will use the LEFT device, which gently vibrates to encourage sleeping on the left side. This therapy could relieve heartburn and regurgitation at night without medication. ^{1 5 6 7 8}

Who Is on the Research Team?

Ronnie Fass, MD

Principal Investigator

Director, Division of Gastroenterology and Hepatology at Metrohealth MC

Abdulfatah Issak, MD

Principal Investigator

Gastroenterology Fellow at Metrohealth MC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to follow sleep positioning therapy.

Able to read, understand, and complete study questionnaires

Have mobile phones with an operating system (Android or iOS) that supports the LEFT device

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline questionnaires and a 7-day symptom record diary

1 week

1 visit (in-person)

Device Accommodation

Participants are trained on the LEFT device and undergo a 10-day accommodation period

10 days

1 visit (in-person)

Treatment

Participants use the LEFT device for positional therapy to manage GERD symptoms

1 month

1 visit (in-person)

Follow-up

Participants complete post-treatment questionnaires and return the LEFT device

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LEFT Device

Trial Overview 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.

How Is the Trial Designed?

Group I: LEFT Device Arm Experimental Treatment 1 Intervention

Subjects in this arm will wear the LEFT device for 1 month

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408713/

Five-year clinical outcomes of RefluxStop surgery in the ... The median (IQR) total GERD-HRQL score improved by 90% (72–98%) from a baseline of 29.5 (33.0–24.0) to 3.0 (0.5–7.5) at 5 years (p < 0.001) and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11458627/

4-year safety and clinical outcomes with the RefluxStop device ... At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589845024001398

A retrospective study assessing RefluxStop surgery for ... Furthermore, patient-reported outcomes of general reflux symptoms exhibited substantial reduction with this intervention, which decreased from 98.7 % at ...

4. link.springer.com link.springer.com/article/10.1007/s10029-025-03339-2

A safety and effectiveness evaluation of RefluxStop in ... At 1-year follow-up, subjects in both groups experienced statistically significant improvements in median (IQR) GERD-HRQL score of 93.8% (81.8%; ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04500288

The Effect of Positional Therapy on Symptoms ... The primary outcome of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12049369/

A safety and effectiveness evaluation of RefluxStop in ... The purpose of this study is to assess the safety results of the RefluxStop device in treating patients with reflux disease and concomitant HH ...

7. trialx.com trialx.com/clinical-trials/listings/323845/safety-and-effectiveness-of-egerd-device-to-reduce-gastroesophageal-reflux-disease-gerd-symptoms/

Safety and Effectiveness of eGERD Device to Reduce ... The purpose of this research is to evaluate the safety and effectiveness of the eGERD device, which is a novel device for treating ...

8. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-020-00794-9

Non-active implantable device treating acid reflux with a new ... Safety parameters. No serious adverse events related to the RefluxStop™ device were reported during the 6-month and 1-year follow-up periods. No ...