Gastroesophageal RefluxNCT00194376
Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
A study testing Continuous positive airway pressure ventilation in people with Gastroesophageal Reflux and Sleep Apnea, run by University of Pennsylvania at 1 site in United States.
Trial summary
Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux, Sleep Apnea
- What is being tested?
- Continuous positive airway pressure ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes
Who cannot join
- any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.
- Conditions
- Gastroesophageal Reflux, Sleep Apnea
- Being tested
- Continuous positive airway pressure ventilation
- Medical subject headings
- Gastroesophageal Reflux, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure ventilationProcedure or surgery
CPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in GERD symptoms
Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- David Metz, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194376
- Sponsor's protocol ID
- 802805
- Status last verified
- Feb 2018
- First submitted
- 14 Sep 2005
- Last updated
- 19 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastroesophageal Reflux in Patients on Continuous Positive Airway Pressure Ventilation for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00194376
- Acronym / sponsor ID
- 802805
- Conditions
- Gastroesophageal Reflux, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Sep 2005 (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.
Patients with a clinically indicated sleep study will be enrolled in this study. They will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. For both studies a pH probe will be placed nasal to measure the amount of acidic reflux during each study. Baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of pH probes
Key exclusion criteria (1 listed)
- any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
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 |
|---|---|---|
| Continuous positive airway pressure ventilationCPAP ventilation is a therapeutic modality which uses positive pressure of air through a sealed nasal mask to treat a condition known as sleep apnea | Procedure or surgery | – |
Primary outcome
Decrease in GERD symptoms
Time frame: 24 hours
Patients suffering from Obstructive Sleep Apnea have been shown to suffer from GERD events more frequesntly and with prolonged episodes compared to controls.
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 19 Feb 2018.
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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.
David Metz, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure ventilation in people with Gastroesophageal Reflux and Sleep Apnea, run by University of Pennsylvania 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 1 inclusion and 1 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 19 Feb 2018. 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?
Decrease in GERD symptoms (time frame: 24 hours). 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 19 Feb 2018.