What side effects are associated with this type of intervention?

Positional therapy for acid reflux, such as using devices to encourage left-side sleeping, generally has minimal side effects, primarily limited to potential discomfort or disrupted sleep due to the device's vibrations. Lifestyle modifications, like elevating the head of the bed and avoiding meals before bedtime, are typically safe but may be inconvenient for some individuals. Proton pump inhibitors (PPIs) can cause side effects such as headaches, diarrhea, constipation, and long-term use may lead to nutrient deficiencies and increased risk of bone fractures. H2 receptor antagonists (H2RAs) may cause headaches, dizziness, and gastrointestinal issues. Overall, positional therapy is a low-risk option compared to pharmacological treatments.

What prior FDA approvals exist?

FDA-approved treatments for acid reflux primarily include pharmacological therapies such as proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs). These medications work by reducing stomach acid production to alleviate symptoms. While the LEFT device focuses on positional therapy to manage nocturnal gastroesophageal reflux by encouraging left-side sleeping, there is no specific mention of FDA-approved positional therapies for acid reflux. However, lifestyle modifications, including positional changes like elevating the head of the bed and sleeping on the left side, are commonly recommended as non-pharmacological approaches to manage GERD symptoms.

What other types of research exist?

Promising novel alternatives to the LEFT device for acid reflux patients include: 1) Antireflux Ablation Therapy (ARAT), which involves endoscopic mucosal resection and ablation to prevent reflux. 2) Transoral Incisionless Fundoplication (TIF), a minimally invasive procedure that reconstructs the valve between the esophagus and stomach to prevent reflux. 3) Stretta Procedure, which uses radiofrequency energy to strengthen the lower esophageal sphincter and reduce reflux. These alternatives have shown potential in clinical studies and may offer effective treatment options in 2024.

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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

Must not have

Patients who are under the age of 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new wearable device called LEFT, designed to help people with nighttime acid reflux by encouraging them to sleep on their left side. The device gently vibrates when it detects the user is not on their left side, helping to reduce acid reflux and improve sleep quality. The study focuses on adults who experience frequent nighttime GERD symptoms that disrupt their sleep.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LEFT Device ArmExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for acid reflux include proton pump inhibitors (PPIs), H2-receptor antagonists (H2RAs), prokinetics, and positional therapy. PPIs work by irreversibly blocking the hydrogen-potassium ATPase enzyme system of the gastric parietal cells, thereby reducing gastric acid production. H2RAs block histamine H2 receptors on parietal cells, also decreasing acid secretion. Prokinetics enhance gastrointestinal motility, helping to clear stomach contents more efficiently. Positional therapy, such as the LEFT device, encourages patients to sleep on their left side, which reduces esophageal acid exposure by minimizing transient lower esophageal sphincter relaxations and promoting faster acid clearance. These mechanisms are crucial for acid reflux patients as they directly address the underlying causes of acid reflux, providing symptom relief and preventing complications.

Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux: A Double-Blind, Randomized, Sham-Controlled Trial.Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease.Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease.