Sleep ApneaNCT01099735
Effect of Continuous Positive Airway Pressure (CPAP) on Lower Esophageal Sphincter Pressure in Morbidly Obese Patients
An observational study of Sleep Apnea and Gastroesophageal Reflux Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This trial is enrolling patients who are already being seen at OHSU weight loss clinic or have been referred for clinical reasons by their physician to the OHSU weight loss clinic and are going to have a esophageal manometry that would be paid for by their insurance company for clinical reasons. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Gastroesophageal Reflux Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients
Who may be able to join
- Adult > 18 yrs old
- Willing to give informed consent
- Undergoing bariatric surgery and scheduled to undergo manometry and polysomnography as part of the protocol.
Who cannot join
- Patient unwilling to give informed consent
- Pregnant women
- Patients with prior history of esophageal surgery (e.g. Nissen fundoplication, partial resection, dilation, stent placement), known anatomic abnormality of the esophagus (e.g. stricture, Schatzki's ring, Zenker's diverticulum, malignancy, varices, ulcers), and/or known functional abnormality of the esophagus (e.g. achalasia, dysmotility).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Effect of Continuous Positive Airway Pressure On Lower Esophageal Sphincter Pressure in Subjects Undergoing Bariatric Surgery
This trial is enrolling patients who are already being seen at OHSU weight loss clinic or have been referred for clinical reasons by their physician to the OHSU weight loss clinic and are going to have a esophageal manometry that would be paid for by their insurance company for clinical reasons.
In patients undergoing weight loss surgery investigators plan to study the effect of continuous positive airway pressure during a esophageal manometry.
Read the detailed description
Subjects will be invited to be in this research study because they are being considered for weight loss (bariatric) surgery that is being paid for by their insurance company. As part of the preparation for surgery, subjects will have a test called manometry that measures pressure in the esophagus (food pipe). For this test, a tube will be lowered down one nostril into the food pipe.
Studies have shown that Continuous Positive Airway Pressure (CPAP) reduces reflux in people with or without sleep apnea as well as in people with reflux. The investigators are trying to understand how this occurs. This research study will add about 10 additional minutes to the clinic visit. The investigators expect about 50 subjects to be in the study at OHSU. Outcomes will be measured at 18 months.
Patients scheduled for esophageal manometry and motility studies prior to their bariatric surgery will be given a study flyer at the bariatric clinic. A list of the patients who are interested in participating in the study will be given to one of the study investigators. A study investigator will call these patients to explain the study, assess their interest in participation, and review their eligibility for entrance into the study. Assessment of eligibility will be done by asking for medical history over the phone as well as by requesting access to their medical record to ensure the patients do not meet exclusion criteria. After review of the patient's clinical history verbally and through review of the medical record, informed consent will be signed at their manometry appointment.
Subjects will undergo the manometry procedure. After finishing the procedure, when the catheter would normally be withdrawn after the procedure, it will remain in place for the study. A CPAP mask will be placed over the subject's nose. CPAP blows air in the nose with a mild pressure. The air pressure will be slowly increased while pressure in the esophagus is being recorded. As done with the regular manometry, the subject will be asked to swallow small amounts of water during the test. The test will be completed in 10 minutes. The CPAP and the tube will be removed.
Subjects will complete a questionnaire prior to the manometry about gastrointestinal symptoms.
- Conditions
- Sleep Apnea, Gastroesophageal Reflux Disease
- Keywords
- Bariatric Surgery, Sleep Apnea, Gastroesophageal Reflux Disease, GERD
- Medical subject headings
- Sleep Apnea Syndromes, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CPAP, Manometry | Patients undergoing Manometry before weight loss surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Esophageal Sphincter Pressure
Effect of CPAP on Lower esophageal sphincter pressure will be assessed after 18 months of data collection or after all 50 patients have been assessed
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Khan, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099735
- Sponsor's protocol ID
- IRB00005565
- Status last verified
- Aug 2019
- First submitted
- 14 Jan 2010
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Positive Airway Pressure On Lower Esophageal Sphincter Pressure in Subjects Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01099735
- Acronym / sponsor ID
- IRB00005565
- Conditions
- Sleep Apnea, Gastroesophageal Reflux Disease
- Keywords
- Bariatric Surgery, Sleep Apnea, Gastroesophageal Reflux Disease, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Apr 2010 (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 trial is enrolling patients who are already being seen at OHSU weight loss clinic or have been referred for clinical reasons by their physician to the OHSU weight loss clinic and are going to have a esophageal manometry that would be paid for by their insurance company for clinical reasons.
In patients undergoing weight loss surgery investigators plan to study the effect of continuous positive airway pressure during a esophageal manometry.
Detailed description
Subjects will be invited to be in this research study because they are being considered for weight loss (bariatric) surgery that is being paid for by their insurance company. As part of the preparation for surgery, subjects will have a test called manometry that measures pressure in the esophagus (food pipe). For this test, a tube will be lowered down one nostril into the food pipe.
Studies have shown that Continuous Positive Airway Pressure (CPAP) reduces reflux in people with or without sleep apnea as well as in people with reflux. The investigators are trying to understand how this occurs. This research study will add about 10 additional minutes to the clinic visit. The investigators expect about 50 subjects to be in the study at OHSU. Outcomes will be measured at 18 months.
Patients scheduled for esophageal manometry and motility studies prior to their bariatric surgery will be given a study flyer at the bariatric clinic. A list of the patients who are interested in participating in the study will be given to one of the study investigators. A study investigator will call these patients to explain the study, assess their interest in participation, and review their eligibility for entrance into the study. Assessment of eligibility will be done by asking for medical history over the phone as well as by requesting access to their medical record to ensure the patients do not meet exclusion criteria. After review of the patient's clinical history verbally and through review of the medical record, informed consent will be signed at their manometry appointment.
Subjects will undergo the manometry procedure. After finishing the procedure, when the catheter would normally be withdrawn after the procedure, it will remain in place for the study. A CPAP mask will be placed over the subject's nose. CPAP blows air in the nose with a mild pressure. The air pressure will be slowly increased while pressure in the esophagus is being recorded. As done with the regular manometry, the subject will be asked to swallow small amounts of water during the test. The test will be completed in 10 minutes. The CPAP and the tube will be removed.
Subjects will complete a questionnaire prior to the manometry about gastrointestinal symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP, Manometry | – | –Patients undergoing Manometry before weight loss surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients
Key inclusion criteria (3 listed)
- Adult > 18 yrs old
- Willing to give informed consent
- Undergoing bariatric surgery and scheduled to undergo manometry and polysomnography as part of the protocol.
Key exclusion criteria (3 listed)
- Patient unwilling to give informed consent
- Pregnant women
- Patients with prior history of esophageal surgery (e.g. Nissen fundoplication, partial resection, dilation, stent placement), known anatomic abnormality of the esophagus (e.g. stricture, Schatzki's ring, Zenker's diverticulum, malignancy, varices, ulcers), and/or known functional abnormality of the esophagus (e.g. achalasia, dysmotility).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lower Esophageal Sphincter Pressure
Time frame: 18 months
Effect of CPAP on Lower esophageal sphincter pressure will be assessed after 18 months of data collection or after all 50 patients have been assessed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- OHSU Pulmonary Critical Care MedicineLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Gastroesophageal Reflux Disease, run by Oregon Health and Science University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Aug 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lower Esophageal Sphincter Pressure (time frame: 18 months). 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 30 Aug 2019.