Impact of Structured Breathing Exercises on Quality of Life in Chronic Pancreatitis- a prospective randomized controlled trial
Physician:
Amit Anand
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.
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
Status:
Recruiting
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
Participant Ages:
Sponsor:
Accepting Healthy Volunteers:
Contact Information:
Clinical Trial Department:
Pulmonary
Study ID:
CR007
Trial Conditions:
Steward Health Care