Trial record 20 of 324 for:    "Idiopathic pulmonary hypertension"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02080533
First received: February 20, 2014
Last updated: March 4, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Other: Slow-paced respiration therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Adherence to slow-paced respiration therapy. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Adherence rates will be assessed by the frequency of days used.


Secondary Outcome Measures:
  • Change in baseline and Week 10 dyspnea scores on the Multidimensional Dyspnea Profile [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 fatigue scores on the Multidimensional Fatigue Inventory [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 sleep scores on the Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 norepinephrine levels [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 interleukin-6 levels [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 tumor necrosis factor-alpha levels [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 six minute walk test [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in baseline and Week 10 right ventricular systolic pressure [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single
Slow-paced respiration therapy
Other: Slow-paced respiration therapy
The FDA-approved RESPeRATE 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080533

Contacts
Contact: Lea Ann Matura, PhD 215 726 8819 matura@nursing.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lea Ann Matura, PhD    215-746-8819    matura@nursing.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Lea Ann Matura, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02080533     History of Changes
Other Study ID Numbers: Penn-SON
Study First Received: February 20, 2014
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
pulmonary arterial hypertension
symptoms
dyspnea
fatigue
sleep

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Syndrome
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014