A Phase 1/2 interventional study of Slow-paced respiration therapy in Pulmonary Arterial Hypertension, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-08-31.
Sponsored by University of Pennsylvania · Phase 1/2, Interventional, and Treatment
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.
773 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 10 is below the median of 38 across 517 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.
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Exclusion Criteria:
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.
Adherence to slow-paced respiration therapy.
Adherence rates will be assessed by the frequency of days used.
Time frame: 10 weeks
Change in baseline and Week 10 dyspnea scores on the Multidimensional Dyspnea Profile
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 fatigue scores on the Multidimensional Fatigue Inventory
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 sleep scores on the Pittsburgh Sleep Quality Index
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 norepinephrine levels
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 interleukin-6 levels
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 tumor necrosis factor-alpha levels
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 six minute walk test
Time frame: Baseline and 10 weeks
Change in baseline and Week 10 right ventricular systolic pressure
Time frame: Baseline and 10 weeks
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Pulmonary Arterial Hypertension →