Trials Sponsors Conditions Drugs Pricing

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 PillowOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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"

Sponsors & Collaborators

Amenity Health, Inc.
Industrycollaborator
Vanderbilt University Medical Center
Otherlead

Study Sites (1)

Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410

Nashville, Tennessee, 37212, United States

Study Officials

Michael F Vaezi, MD,PhD
Vanderbilt University
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Sleep Position May Reduce Acid Reflux Symptoms at Night

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Patients with nocturnal extraesophageal reflux

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Patients with nocturnal extraesophageal reflux

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations