Extra-esophageal RefluxNCT02320968
Sleep Position May Reduce Acid Reflux Symptoms at Night
A study testing MedclineTM Sleep Assist Pillow in people with Extra-esophageal Reflux, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Extra-esophageal Reflux
- What is being tested?
- MedclineTM Sleep Assist Pillow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center, Endoscopy Lab, TVC 1410
Nashville, Tennessee, 37212
About this study
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
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
Read the 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.
- Conditions
- Extra-esophageal Reflux
- Being tested
- MedclineTM Sleep Assist Pillow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MedclineTM Sleep Assist Pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
Number of patients with improved sleep quality
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.
Measured: 30 days
Number of patients with improved daytime extraesphageal reflux symptoms
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extra-esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Amenity Health, Inc.
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University Medical Center
- Investigators
- Michael F Vaezi, MD,PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320968
- Sponsor's protocol ID
- 141619
- Status last verified
- Apr 2017
- First submitted
- 11 Dec 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02320968
- Acronym / sponsor ID
- 141619
- Conditions
- Extra-esophageal Reflux
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Amenity Health, Inc.
- Study start
- Dec 2014
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with nocturnal extraesophageal reflux | Experimental | Other: MedclineTM Sleep Assist PillowThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedclineTM Sleep Assist PillowThe 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. | Other | Patients with nocturnal extraesophageal reflux |
Primary outcome
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.
2 secondary outcomes
Number of patients with improved sleep quality
Time frame: 30 days
Number of patients with improved daytime extraesphageal reflux symptoms
Time frame: 30 days
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
Related trials for Extra-esophageal Reflux
Active, not recruitingObservational study
Evaluation of Upper Esophageal Sphincter Motor Activity in Patients with Extra Esophageal Reflux Symptoms
Gastroesophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Vaezi, MD,PhD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedclineTM Sleep Assist Pillow in people with Extra-esophageal Reflux, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with reduced esophageal acid exposure during sleep (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.