Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01099735
Other study ID # IRB00005565
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date June 2012

Study information

Verified date August 2019
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

In patients undergoing weight loss surgery investigators plan to study the effect of continuous positive airway pressure during a esophageal manometry.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria

1. Adult > 18 yrs old

2. Willing to give informed consent

3. Undergoing bariatric surgery and scheduled to undergo manometry and polysomnography as part of the protocol.

Exclusion Criteria

1. Patient unwilling to give informed consent

2. Pregnant women

3. 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).

Study Design


Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 18 months
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT03919955 - A Novel Pharmacological Therapy for Obstructive Sleep Apnea Phase 2
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01503164 - Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism N/A
Recruiting NCT00747890 - Surgical Treatment of Mild Obstructive Sleep Apnea N/A
Active, not recruiting NCT00738179 - Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease Phase 3
Completed NCT00841906 - Alice PDx User/Validation Extended Trial N/A
Completed NCT00202501 - Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome N/A
Completed NCT00047463 - Effects of Treating Obstructive Sleep Apnea in Epilepsy Phase 2
Not yet recruiting NCT06029881 - Portable System for Non-intrusive Monitoring of Sleep
Recruiting NCT06093347 - Central Apnoea Monitor Study
Terminated NCT05445869 - Severe OSA Study (SOS) N/A
Withdrawn NCT04096261 - The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Recruiting NCT04575740 - Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea N/A
Completed NCT04676191 - Validation of a Contactless Vital Signs Measurement Sensor N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT06051097 - Metabolic Syndrome and Obstructive Sleep Apnea
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury