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Sleep Position May Reduce Acid Reflux Symptoms at Night

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Amenity Health, Inc.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02320968
First received: December 11, 2014
Last updated: February 21, 2017
Last verified: January 2017
  Purpose
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.

Condition Intervention
Extra-esophageal Reflux
Device: MedclineTM Sleep Assist Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Sleep Position Reduces Acid Reflux and Decreases Extraesophageal Reflux Symptoms: A Non-randomized Prospective Study of the Amenity Health MedclineTM Sleep Assist Device

Resource links provided by NLM:


Further study details as provided by Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Number of patients with reduced esophageal acid exposure during sleep [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures:
  • Number of patients with improved sleep quality [ Time Frame: 30 days ]
    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 sleep quality and overall quality of life was improved.

  • Number of patients with improved daytime extraesphageal reflux symptoms [ Time Frame: 30 days ]
    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 sleep quality and overall quality of life was improved.


Estimated Enrollment: 20
Study Start Date: December 2014
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with nocturnal extraesophageal reflux
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.
Device: MedclineTM Sleep Assist Device
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.

Detailed Description:

The MedcineTM Sleep Assist Device was recently developed by Amenity Health, Inc and is designed to elevate the head and torso and maintain a patient in the left-lateral position in order to decrease night-time/nocturnal acid reflux. The MedcineTM Sleep Assist Device is composed of a 9-inch incline base and a wrap-around body pillow. Traditionally wedge pillows have been recommended for patients with acid reflux. The addition of the body pillow helps to maintain the patient in the left-lateral position (LLP) during sleep, which has been shown to reduce night-time reflux compared to wedge alone, right lateral position and/or sleeping flat.

In healthy controls, sleeping in the left-lateral position with this device system significantly decreased esophageal acid exposure and overall episodes of acid reflux. To date, there has been no study in patients with extra-esophageal reflux (EER) and nocturnal heartburn.

Primary Objectives The primary objective of the this study is to evaluate the effect of a reflux pillow on esophageal acid exposure in patients complaining of nocturnal EER.

Secondary Objectives To evaluate the effect of the reflux pillow on nocturnal EER symptoms, sleep quality, daytime EER symptoms, and overall quality of life.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02320968

Locations
United States, Tennessee
Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Amenity Health, Inc.
Investigators
Principal Investigator: Michael F Vaezi, MD,PhD Vanderbilt University
  More Information

Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02320968     History of Changes
Other Study ID Numbers: 141619 
Study First Received: December 11, 2014
Last Updated: February 21, 2017

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 23, 2017