Sleep Position May Reduce Acid Reflux Symptoms at Night

NCT02320968 | Terminated

• 1 other identifier: 141619
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.

Conditions

Extra-esophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Number of patients with reduced esophageal acid exposure during sleep

  The patient will use the sleep assist device from days 3 - 30 and will complete various questionnaires at weeks 2 and 4 to determine if night-time reflux symptoms were improved.

  30 days

Secondary Outcomes (2)

• Number of patients with improved sleep quality

  30 days

• Number of patients with improved daytime extraesphageal reflux symptoms

  30 days

Study Arms (1)

Patients with nocturnal extraesophageal reflux

EXPERIMENTAL

This is a non-randomized study to evaluate the effectiveness of the MedclineTM Sleep Assist Device on patients who experience nocturnal extraesophageal reflux. All patients will receive the device. Participants will serve as their own controls while undergoing 96-hour pH monitoring. Participants will follow their regular sleep position patterns on Days 1 and 2 of the study and will use the sleep assist device on Days 3 and 4. pH data and patient report of symptoms will be evaluated during the initial 96 hours of the study to capture physiologic results. All participants will use the sleep assist device for the remainder of the study to determine if a reduction in overall reflux symptom index (RSI) is achieved.

Other: MedclineTM Sleep Assist Pillow

Interventions

MedclineTM Sleep Assist Pillow OTHER

The pillow is designed so that the sleeper can have proper upper-body elevation while sleeping on his or her left side without the need for placing blocks under the head of the bed and bothering anyone else who may be sleeping in the bed. The pillow supports the patient's head, back and body to provide comfort while reducing or relieving acid reflux symptoms during sleep.

Patients with nocturnal extraesophageal reflux

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between the ages of 18 and 65;
• Between 5'4" and 6'2"
• Body Mass Index\<32
• Willing and able to provide written informed consent;
• Understands the clinical study requirements and is able to comply with the follow-up schedule set forth in the protocol;
• Clinically diagnosed with gastroesophageal reflux disease with extra-esophageal symptoms (i.e. chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing);
• Presents with Reflux Symptom Index (RSI) \> 13;
• Undergoing Esophagogastroduodenoscopy (EGD) as part of routine care;
• Undergoing 96-hour pH monitoring via BRAVO capsule as part of routine care.

You may not qualify if:

• Currently being treated with another investigational medical device and/or drug;
• Currently receiving treatment for sleep apnea with continuous positive airway pressure (CPAP);
• Female patients who are of child-bearing potential and not using an acceptable method of birth control, or is pregnant or breast-feeding;
• Suspected esophageal cancer;
• Confirmed nasopharyngeal cancer;
• Previously undergone Nissen Fundoplication;
• Hiatal hernia \> 4 cm

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Amenity Health, Inc.: collaborator

Study Sites (1)

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410

Nashville, Tennessee, 37212, United States

Location

Study Officials

• Michael F Vaezi, MD,PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 19, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)