TerminatedNot Applicable

Sleep Disordered Breathing in Precapillary Pulmonary Hypertension: Effect of CPAP Treatment

Stopped: Not enough participants

Belgium8 participantsStarted 2014-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PVR (pulmonary vascular resistance)

Timeframe: change in PVR from inclusion at 6 months

Trial details

NCT IDNCT02583906

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05

View on ClinicalTrials.gov More Sleep-Disordered Breathing trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.