Pulmonary HypertensionNCT04769635
CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension
A study testing CPAP therapy in people with Pulmonary Hypertension, run by Zagazig University at 1 site in Egypt.
Trial summary
All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- CPAP therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2019to 15 Oct 2020
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).
Who cannot join
- Patients aged < 18 years
- Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders.
- Patients on long term oxygen therapy (LTOT).
- Patients with respiratory neuromuscular weaknesses or chest wall deformities.
- End-organ failure and malignancies
- Obesity hypoventilation syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients
All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
Echocardiography:
Read more
It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.
Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (>55 mmHg) degrees.
Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).
- Conditions
- Pulmonary Hypertension
- Being tested
- CPAP therapy
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP therapyDevice
All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
| Study group | Role | What they receive |
|---|---|---|
| CPAP ttt | Experimental | Not described Receives: Device: CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of mean pulmonary artery pressure measured by echo
Measured: 3 months
Secondary outcomes (2)
Exercise capacity improvement measured by six minute walking test
Measured: 3 months
Exercise capacity improvement measured by maximun o2 consumption
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start15 Oct 2019
- Primary completion20 Apr 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmad Abbas, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769635
- Sponsor's protocol ID
- ZU-IRB#5654
- Status last verified
- Feb 2021
- First submitted
- 20 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Continuous Positive Airway Pressure Therapy on Pulmonary Hypertension and Exercise Capacity in Newly Diagnosed Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT04769635
- Acronym / sponsor ID
- ZU-IRB#5654
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 24 Feb 2021 (actual)
- 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.
All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
Echocardiography:
It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.
Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (>55 mmHg) degrees.
Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP ttt | Experimental | Device: CPAP therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).
Key exclusion criteria (6 listed)
- Patients aged < 18 years
- Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders.
- Patients on long term oxygen therapy (LTOT).
- Patients with respiratory neuromuscular weaknesses or chest wall deformities.
- End-organ failure and malignancies
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 |
|---|---|---|
| CPAP therapyAll studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr | Device | CPAP ttt |
Primary outcome
change of mean pulmonary artery pressure measured by echo
Time frame: 3 months
2 secondary outcomes
Exercise capacity improvement measured by six minute walking test
Time frame: 3 months
Exercise capacity improvement measured by maximun o2 consumption
Time frame: 3 months
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 24 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP therapy in people with Pulmonary Hypertension, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 6 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 24 Feb 2021. 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 Egypt. 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.
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?
change of mean pulmonary artery pressure measured by echo (time frame: 3 months). 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 24 Feb 2021.