Clinical trial NCT03495219: Can Individuals Control Pressure in Their Esophagus.
Official title: Subjects Ability to Control Pressure in the Lower Esophageal High Pressure Znoe (HPZ) During Manometry.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gastroesophageal Reflux
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing outpatient ambulatory procedures at Mayo Clinic Jacksonville.

Brief summary: To establish to what degree individuals can increase esophageal high pressure zone (HPZ) after instruction in deep breathing as evidenced by concurrent manometric pressure readings.

Detailed description: Pressure in the lower esophagus has been negatively associated with reflux symptoms: the lower the pressure, the more reflux symptoms. This pressure can be augmented with deep abdominal breathing. This can be detected during esophageal manometry, when a pressure catheter is placed into the esophagus. Manometry is routinely done for swallowing disorders.

This study will take place just after a routine manometry test, when the subject still has the catheter in place. All that is required for the research portion is to observe manometry readings while they breathe, then when they deep breath, then breathe after they have been cued or coached to deep abdominal breathing. This is done in sequence to establish how quickly this pressure can be improved.

This coached breathing is then prescribed as a routine exercise and long term follow up performed via phone to see how their reflux symptoms have responded.

Eligibility criteria: Inclusion Criteria:

-Eligibility is forwarded to all individuals undergoing routine esophageal manometry. They would have had to have met all eligibility criteria for this procedure.

Exclusion criteria:

-Individuals undergoing modified barium swallow studies (MBSS). Exclusion from MBSS would preclude inclusion in this study.

Primary outcomes:
measure: Reduction in Reflux Symptom Index Score (RSI)
timeFrame: 3 months.
Secondary outcomes:
measure: Association of RSI to resting manometry pressure in the lower esophagus
timeFrame: 1 day
measure: Can lower esophageal pressure can be increased by instruction/coaching by a physical therapist.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: C J Yelvington
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun XH, Ke MY, Wang ZF, Fang XC. [Roles of diaphragmatic crural barrier and esophageal body clearance in patients with gastroesophageal reflux disease]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2002 Jun;24(3):289-93. Chinese.
citation: Ding ZL, Wang ZF, Sun XH, Ke MY. [Therapeutic mechanism of diaphragm training at different periods in patients with gastroesophageal reflux disease]. Zhonghua Yi Xue Za Zhi. 2013 Oct 29;93(40):3215-9. Chinese.
citation: Eherer AJ, Netolitzky F, Hogenauer C, Puschnig G, Hinterleitner TA, Scheidl S, Kraxner W, Krejs GJ, Hoffmann KM. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol. 2012 Mar;107(3):372-8. doi: 10.1038/ajg.2011.420. Epub 2011 Dec 6.