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Sleep Position May Reduce Acid Reflux Symptoms at Night

This study has been terminated.
(low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02320968
First Posted: December 19, 2014
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amenity Health, Inc.
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center
  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 Other: MedclineTM Sleep Assist Pillow

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Michael Vaezi, 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.


Enrollment: 10
Study Start Date: December 2014
Study Completion Date: March 1, 2017
Primary Completion Date: March 1, 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.
Other: MedclineTM Sleep Assist Pillow
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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320968


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

Responsible Party: Michael Vaezi, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02320968     History of Changes
Other Study ID Numbers: 141619
First Submitted: December 11, 2014
First Posted: December 19, 2014
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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