Pulmonary Arterial HypertensionPhase 1/2NCT02080533
Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension
A Phase 1/2 study testing Slow-paced respiration therapy in people with Pulmonary Arterial Hypertension, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Slow-paced respiration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Slow-paced respiration therapy
- Keywords
- pulmonary arterial hypertension, symptoms, dyspnea, fatigue, sleep
- Medical subject headings
- Pulmonary Arterial Hypertension, Dyspnea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-paced respiration therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Slow-paced respiration therapy Receives: Other: Slow-paced respiration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to slow-paced respiration therapy.
Adherence rates will be assessed by the frequency of days used.
Measured: 10 weeks
Secondary outcomes (8)
Change in baseline and Week 10 dyspnea scores on the Multidimensional Dyspnea Profile
Measured: Baseline and 10 weeks
Change in baseline and Week 10 fatigue scores on the Multidimensional Fatigue Inventory
Measured: Baseline and 10 weeks
Change in baseline and Week 10 sleep scores on the Pittsburgh Sleep Quality Index
Measured: Baseline and 10 weeks
Change in baseline and Week 10 norepinephrine levels
Measured: Baseline and 10 weeks
Change in baseline and Week 10 interleukin-6 levels
Measured: Baseline and 10 weeks
Change in baseline and Week 10 tumor necrosis factor-alpha levels
Measured: Baseline and 10 weeks
Change in baseline and Week 10 six minute walk test
Measured: Baseline and 10 weeks
Change in baseline and Week 10 right ventricular systolic pressure
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Ann Matura, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080533
- Sponsor's protocol ID
- Penn-SON
- Status last verified
- Aug 2016
- First submitted
- 20 Feb 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Slow-paced Respiration Therapy for Treatment of a Symptom Cluster in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02080533
- Acronym / sponsor ID
- Penn-SON
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- pulmonary arterial hypertension, symptoms, dyspnea, fatigue, sleep
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: Slow-paced respiration therapySlow-paced respiration therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow-paced respiration therapyThe 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. | Other | Single |
Primary outcome
Adherence to slow-paced respiration therapy.
Time frame: 10 weeks
Adherence rates will be assessed by the frequency of days used.
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Ann Matura, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Slow-paced respiration therapy in people with Pulmonary Arterial Hypertension, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to slow-paced respiration therapy. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.