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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080533
• Other study ID #: Penn-SON
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 20, 2014
• Last updated: August 29, 2016
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to slow-paced respiration therapy.	Adherence rates will be assessed by the frequency of days used.	10 weeks	No
Secondary	Change in baseline and Week 10 dyspnea scores on the Multidimensional Dyspnea Profile		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 fatigue scores on the Multidimensional Fatigue Inventory		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 sleep scores on the Pittsburgh Sleep Quality Index		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 norepinephrine levels		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 interleukin-6 levels		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 tumor necrosis factor-alpha levels		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 six minute walk test		Baseline and 10 weeks	No
Secondary	Change in baseline and Week 10 right ventricular systolic pressure		Baseline and 10 weeks	No