Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02080533
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2014-02-20
Brief Title:
Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 investigators 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None