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NCT02080533 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT02080533: Completed Phase 1 study, sponsored by University of Pennsylvania.

NCT02080533 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02080533, a Phase 1 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study 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.

Primary Outcome

Adherence rates will be assessed by the frequency of days used.

Interventions

  • OTHER Slow-paced respiration therapy

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2014-02
Est. Completion 2016-03
Phase Phase 1
University of Pennsylvania

1,423 total trials

What the finished NCT02080533 record still lists

NCT02080533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Slow-paced respiration therapy is the first listed.

NCT02080533 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02080533 about?

NCT02080533 is a clinical study titled "Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension". 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 prev...

What is the current status of trial NCT02080533?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-02. Estimated completion is 2016-03.

What interventions are being tested in trial NCT02080533?

The interventions under investigation include: Slow-paced respiration therapy (OTHER).

Who is sponsoring clinical trial NCT02080533?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02080533's enrollment target sits among peer trials

10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02080533, the US trial registry maintained by the National Library of Medicine. NCT02080533 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.