Study ID
CR007
Status
Study Information
  • Patients will fill out baseline Quality of Life and Sleep questionnaires.
  • Patients who meet criteria for sleep disturbance based on screening questionnaire will be referred for a Pulmonology/Sleep consult for a polysomnography (PSG) for further evaluation to rule in or rule out obstructive sleep apnea.
  • Patients who rule in for sleep apnea on the PSG based on a Apnea/Hypopnea Index (AHI) of greater than 10 will proceed to standard of care intervention at the discretion of the Pulmonologist- and will be followed with follow up questionnaires at the end of 3 months. They will not participate in the breathing meditation arm of the study.
  • Patients who rule out for sleep apnea will then proceed to be included for PAMPAS intervention
  • Study patients will then undergo simple randomization to two groups: Placebo breathing exercise (Control) and PAMPAS group
  • After completion of intervention, all patients participating in the study (those with and without apnea) will complete follow up Quality of Life and Sleep questionnaires, to evaluate impact of intervention on their quality of life.

 

Physician
Contact Information
Arthur Dea
Research Coordinator
Tel: 617-789-2078
Email: arthur.dea@steward.org
 
 
Clinical Trial Department
Purpose of Trial
Primary objectives:
• Evaluate impact of structured breathing exercises as a non-pharmacological intervention on quality of life metrics in patients with chronic pancreatitis

Secondary objectives
• Identify prevalence of undiagnosed sleep disturbances in patients with chronic pancreatitis
• Evaluate impact of sleep disorder intervention on the quality of life in patients with chronic pancreatitis

Eligibility
Inclusion Criteria
  • Radiographic evidence of pancreatic calcifications
  • Endoscopic evidence of chronic pancreatitis
  • Positive secretin pancreatic function test

Exclusion Criteria

  • Co-existing end stage co-morbidities (e.g. chronic heart failure, atrial fibrillation, uncontrolled COPD/asthma, cirrhosis, history of MI within the last 6 months, end stage renal disease on HD)
  • HIV
  • Pre-existing sleep/respiratory disorder
  • Pre-existing neuro-psychiatric disorder
  • Ongoing illicit drug use
  • Acute flare of their chronic pancreatitis during the study

*For a list of all eligibility criteria, please contact the Research Team