Sleep ApneaPOSAPHNCT05595200
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
An observational study of Sleep Apnea and Obstructive Sleep Apnea, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive Sleep Apnea, Pulmonary Hypertension
- What is being tested?
- Level III portable sleep study
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Consecutive patients admitted to Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College diagnosed with pulmonary hypertension that meet inclusion and exclusion criteria.
Who may be able to join
- Aged ≥18 years old
- Diagnosed with pulmonary hypertension by right heart catheterization
Who cannot join
- Pregnancy
- Central sleep apnea
- Previous treatment for sleep-disordered breathing
- Unavailable or incomplete sleep data
- Requiring nocturnal oxygen supplementation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC
Beijing, 100037
Zhihong Liu, MD,PhD, +861088396590, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
About this study
The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.
Read the detailed description
Obstructive sleep apnea (OSA) is a highly prevalent sleep-breathing disorder that affects over 1 billion adults worldwide, resulting in a substantial economic and medical burden. Multiple cardiovascular comorbidities and mortality are associated with OSA due to intermittent hypoxemia, intrathoracic pressure swings, sympathetic activation, endothelial dysfunction, and systemic inflammation. Large epidemiological studies have shown that OSA is more prevalent in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension than in the general population. Thus, elucidating the effects of OSA on adverse outcomes in patients with pulmonary hypertension is crucial in risk assessments and therapeutic recommendations for affected individuals. There is, however, insufficient evidence to determine whether OSA and associated physiological sequelae/phenotypes have a prognostic impact on these patients. The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea, Pulmonary Hypertension, Epidemiology, Predictor, Prognosis
- Being tested
- Level III portable sleep study
- Keywords
- Sleep Apnea, Pulmonary Hypertension, Obstructive Sleep Apnea, Hypoxemia, Prognosis, Prevalence, Predictor, Phenotype, Outcome
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypertension, Pulmonary, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level III portable sleep studyDiagnostic test
Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Study Group | All subjects diagnosed with pulmonary hypertension by right heart catheterization agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria Receives: Diagnostic Test: Level III portable sleep study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
The composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality.
Measured: 1 year
Secondary outcomes (3)
Individual clinical worsening outcomes
Number of patients with reduction in exercise capacity, reduction in WHO functional classes, non-elective hospitalization for pulmonary hypertension and all-cause mortality.
Measured: 1 year, 3 years and 5 years
Clinical worsening
The composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality.
Measured: 3 year, 5 years
All-cause mortality
All-cause mortality
Measured: 1 year, 3 year, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 May 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595200
- Sponsor's protocol ID
- SAPH
- Acronym
- POSAPH
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Duan A, Huang Z, Hu M, Zhao Z, Zhao Q, Jin Q, Yan L, Zhang Y, Li X, An C, Luo Q, Liu Z. The comorbidity burden and disease phenotype in pre-capillary pulmonary hypertension: The contributing role of obstructive sleep apnea. Sleep Med. 2023 Jan;101:146-153. doi: 10.1016/j.sleep.2022.10.029. Epub 2022 Nov 2.
PubMed 36395719Huang Z, Duan A, Hu M, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Implication of prolonged nocturnal hypoxemia and obstructive sleep apnea for pulmonary hemodynamics in patients being evaluated for pulmonary hypertension: a retrospective study. J Clin Sleep Med. 2023 Feb 1;19(2):213-223. doi: 10.5664/jcsm.10286.
PubMed 36081323Hu M, Duan A, Huang Z, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Development and Validation of a Nomogram for Predicting Obstructive Sleep Apnea in Patients with Pulmonary Arterial Hypertension. Nat Sci Sleep. 2022 Aug 9;14:1375-1386. doi: 10.2147/NSS.S372447. eCollection 2022.
PubMed 35971464Huang Z, Duan A, Zhao Z, Zhao Q, Zhang Y, Li X, Zhang S, Gao L, An C, Luo Q, Liu Z. Sleep-disordered breathing patterns and prognosis in pulmonary arterial hypertension: A cluster analysis of nocturnal cardiorespiratory signals. Sleep Med. 2024 Jan;113:61-69. doi: 10.1016/j.sleep.2023.11.016. Epub 2023 Nov 13.
PubMed 37984019
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT05595200
- Acronym / sponsor ID
- POSAPH / SAPH
- Conditions
- Sleep Apnea, Obstructive Sleep Apnea, Pulmonary Hypertension, Epidemiology, Predictor, Prognosis
- Keywords
- Sleep Apnea, Pulmonary Hypertension, Obstructive Sleep Apnea, Hypoxemia, Prognosis, Prevalence, Predictor, Phenotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Oct 2022 (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.
The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.
Detailed description
Obstructive sleep apnea (OSA) is a highly prevalent sleep-breathing disorder that affects over 1 billion adults worldwide, resulting in a substantial economic and medical burden. Multiple cardiovascular comorbidities and mortality are associated with OSA due to intermittent hypoxemia, intrathoracic pressure swings, sympathetic activation, endothelial dysfunction, and systemic inflammation. Large epidemiological studies have shown that OSA is more prevalent in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension than in the general population. Thus, elucidating the effects of OSA on adverse outcomes in patients with pulmonary hypertension is crucial in risk assessments and therapeutic recommendations for affected individuals. There is, however, insufficient evidence to determine whether OSA and associated physiological sequelae/phenotypes have a prognostic impact on these patients. The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Level III portable sleep studyAll subjects diagnosed with pulmonary hypertension by right heart catheterization agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College diagnosed with pulmonary hypertension that meet inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Aged ≥18 years old
- Diagnosed with pulmonary hypertension by right heart catheterization
Key exclusion criteria (5 listed)
- Pregnancy
- Central sleep apnea
- Previous treatment for sleep-disordered breathing
- Unavailable or incomplete sleep data
- Requiring nocturnal oxygen supplementation
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 |
|---|---|---|
| Level III portable sleep studyRecruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge | Diagnostic test | Study Group |
Primary outcome
Clinical worsening
Time frame: 1 year
The composite event of a reduction in exercise capacity (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality.
3 secondary outcomes
Individual clinical worsening outcomes
Time frame: 1 year, 3 years and 5 years
Clinical worsening
Time frame: 3 year, 5 years
All-cause mortality
Time frame: 1 year, 3 year, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 36395719Duan A, Huang Z, Hu M, Zhao Z, Zhao Q, Jin Q, Yan L, Zhang Y, Li X, An C, Luo Q, Liu Z. The comorbidity burden and disease phenotype in pre-capillary pulmonary hypertension: The contributing role of obstructive sleep apnea. Sleep Med. 2023 Jan;101:146-153. doi: 10.1016/j.sleep.2022.10.029. Epub 2022 Nov 2.
- Background: PubMed 36081323Huang Z, Duan A, Hu M, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Implication of prolonged nocturnal hypoxemia and obstructive sleep apnea for pulmonary hemodynamics in patients being evaluated for pulmonary hypertension: a retrospective study. J Clin Sleep Med. 2023 Feb 1;19(2):213-223. doi: 10.5664/jcsm.10286.
- Background: PubMed 35971464Hu M, Duan A, Huang Z, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Development and Validation of a Nomogram for Predicting Obstructive Sleep Apnea in Patients with Pulmonary Arterial Hypertension. Nat Sci Sleep. 2022 Aug 9;14:1375-1386. doi: 10.2147/NSS.S372447. eCollection 2022.
- Background: PubMed 37984019Huang Z, Duan A, Zhao Z, Zhao Q, Zhang Y, Li X, Zhang S, Gao L, An C, Luo Q, Liu Z. Sleep-disordered breathing patterns and prognosis in pulmonary arterial hypertension: A cluster analysis of nocturnal cardiorespiratory signals. Sleep Med. 2024 Jan;113:61-69. doi: 10.1016/j.sleep.2023.11.016. Epub 2023 Nov 13.
- Individual participant dataSharing planned: Undecided
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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.
Zhihong Liu principal investigator
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Obstructive Sleep Apnea, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu, M.D., Ph.D (+861088396590, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595200, which also lists 4 linked publications.
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 26 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.