NCT05595200 Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
| NCT ID | NCT05595200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Pulmonary Vascular Disease Research Group |
| Condition | Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 480 participants |
| Start Date | 2020-05-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 480 participants in total. It began in 2020-05-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years old * Diagnosed with pulmonary hypertension by right heart catheterization Exclusion Criteria: * Pregnancy * Central sleep apnea * Previous treatment for sleep-disordered breathing * Unavailable or incomplete sleep data * Requiring nocturnal oxygen supplementation
Contact & Investigator
Zhihong Liu
PRINCIPAL INVESTIGATOR
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Frequently Asked Questions
Who can join the NCT05595200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05595200 currently recruiting?
Yes, NCT05595200 is actively recruiting participants. Contact the research team at zhihongliufuwai@163.com for enrollment information.
Where is the NCT05595200 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05595200 clinical trial?
NCT05595200 is sponsored by Chinese Pulmonary Vascular Disease Research Group. The principal investigator is Zhihong Liu at Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The trial plans to enroll 480 participants.