Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2014 |
| End Date: | March 2016 |
| Contact: | Lea Ann Matura, PhD |
| Email: | matura@nursing.upenn.edu |
| Phone: | 215 726 8819 |
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.
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.
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
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