Sleep-Disordered BreathingNCT02583906
Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
A study testing CPAP in people with Sleep-Disordered Breathing and Pulmonary Arterial Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- minimum 18 years old
- diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
- diagnosis of PAH based on cardiac catherisation
- diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
- recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months
Who cannot join
- congenital heart disease
- moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value
- BMI 35kg/m2 or more
- patients already treated with CPAP
- patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.
Read the detailed description
The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.
The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.
- Conditions
- Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Being tested
- CPAP
- Medical subject headings
- Sleep Apnea Syndromes, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called CONTINUOUS POSITIVE AIRWAY PRESSURE
Treatment with CPAP for six months in the CPAP arm.
| Study group | Role | What they receive |
|---|---|---|
| cpap treatment | Other | patients randomized to the 'no cpap' arm will not be treated by CPAP Receives: Device: CPAP |
| no cpap | No intervention | patients randomized to the 'cpap' arm will be treated by CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PVR (pulmonary vascular resistance)
Measured: change in PVR from inclusion at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: Not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catharina Belge, MDPhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583906
- Sponsor's protocol ID
- S55742
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2014
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment
- ClinicalTrials.gov ID
- NCT02583906
- Acronym / sponsor ID
- S55742
- Conditions
- Sleep-Disordered Breathing, Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough participants
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Oct 2015 (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.
Evaluation of the effect of CPAP (continuous positive airway pressure ) treatment in PAH (pulmonary arterial hypertension) and CTEPH (chronic thromboembolic pulmonary hypertension) patients suffering from sleep disordered breathing.
Detailed description
The primary endpoint of the study is to evaluate the effect of CPAP therapy on pulmonary vascular resistance in PAH and CTEPH patients suffering from sleep disordered breathing.
The secondary endpoints are the effect of CPAP on right atrium and right ventricle diameter and ejection fraction measured by echocardiography, 6 minutes walk distance, NYHA class, QOL, endothelial function, sympathetic activity and prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cpap treatment | Other | Device: CPAPpatients randomized to the 'no cpap' arm will not be treated by CPAP |
| no cpap | No intervention | –patients randomized to the 'cpap' arm will be treated by CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- minimum 18 years old
- diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension
- diagnosis of PAH based on cardiac catherisation
- diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy
- recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before inclusion showing AHI above 15) stable clinical condition for at least 3 months before inclusion as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months
Key exclusion criteria (5 listed)
- congenital heart disease
- moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value
- BMI 35kg/m2 or more
- patients already treated with CPAP
- patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24)
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 |
|---|---|---|
| CPAPAlso: CONTINUOUS POSITIVE AIRWAY PRESSURETreatment with CPAP for six months in the CPAP arm. | Device | cpap treatment |
Primary outcome
Change in PVR (pulmonary vascular resistance)
Time frame: change in PVR from inclusion at 6 months
Results and safety
The study was stopped early (reason given: Not enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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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.
Catharina Belge, MDPhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 in people with Sleep-Disordered Breathing and Pulmonary Arterial Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jan 2023. 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 Belgium. 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 was stopped early (reason given: Not enough participants). Results are not available in the source record.
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 in PVR (pulmonary vascular resistance) (time frame: change in PVR from inclusion at 6 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 27 Jan 2023.