DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: Slow-paced respiration therapy (Other)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Lea Ann Matura, PhD, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Lea Ann Matura, PhD, Phone: 215 726 8819, Email: matura@nursing.upenn.edu

Summary

Pulmonary arterial hypertension (PAH) is a chronic illness characterized by increased pulmonary pressures resulting in right heart failure and premature death. Common symptoms that impair quality of life and functioning are dyspnea, fatigue and sleep disturbance. This trio of symptoms is highly prevalent and forms a symptom cluster (2 or more symptoms that co-occur) in PAH. From a biological, proinflammatory cytokines are implicated in dyspnea, fatigue and sleep disturbance; there is activation of the sympathetic nervous system (SNS) and an inherent inflammatory process in PAH that contributes to the pathophysiology, but the link to this symptom cluster has not been investigated. One novel, treatment for symptom clusters is slow-paced respiration therapy using the FDA-approved device, RESPeRATE. The device contains headphones and a sensor that attaches to the chest to detect inhalation and exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to decrease respirations. RESPeRATE moderates effects of the SNS; lowers blood pressure; improves functional capacity and ejection fraction; and significantly decreases pulmonary pressures in left heart failure. The investigators will enroll 10 women with PAH to use the RESPeRATE device to perform slow-paced respiration for 15 minutes per day for 8 weeks to determine the feasibility and effects on the SNS and inflammatory activity and the symptom cluster. The investigator's overall hypothesis is that, as compared to baseline, after eight weeks of therapy women with PAH who receive slow-based respiration therapy will have lower SNS activity and inflammatory levels, and improved dyspnea, fatigue and sleep disturbance.

Clinical Details

Official title: Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adherence to slow-paced respiration therapy.

Secondary outcome:

Change in baseline and Week 10 dyspnea scores on the Multidimensional Dyspnea Profile

Change in baseline and Week 10 fatigue scores on the Multidimensional Fatigue Inventory

Change in baseline and Week 10 sleep scores on the Pittsburgh Sleep Quality Index

Change in baseline and Week 10 norepinephrine levels

Change in baseline and Week 10 interleukin-6 levels

Change in baseline and Week 10 tumor necrosis factor-alpha levels

Change in baseline and Week 10 six minute walk test

Change in baseline and Week 10 right ventricular systolic pressure

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Previous documentation of mean pulmonary artery pressure > 25 mm Hg with a pulmonary

capillary wedge pressure (or left ventricular end-diastolic pressure) < 16 mm Hg and PVR > 3 WU at any time before study entry.

- Women with WHO Group I PAH (idiopathic, heritable, or associated with connective

tissue disease, congenital heart disease, anorexigens or HIV)

- Targeted PAH therapy at stable dose for 3 months

- Age >21 years

- Ability to perform six minute walk testing without limitations in musculoskeletal

function or coordination.

- Informed consent

Exclusion Criteria:

- Age < 21

- Hypotension (blood pressure < 90/60 mmHg)

- Pregnancy

- Chronic Fatigue Syndrome (current or history of)

- Known sleep disorder (obstructive sleep apnea, restless leg syndrome, narcolepsy,

current or history of)

- Hospitalized or acutely ill

- Major Depression (current or history of)

- Lung transplant recipient

Locations and Contacts

Lea Ann Matura, PhD, Phone: 215 726 8819, Email: matura@nursing.upenn.edu

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Lea Ann Matura, PhD, Phone: 215-746-8819, Email: matura@nursing.upenn.edu
Additional Information

Starting date: February 2014
Last updated: December 18, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017