Obstructive Sleep Apnea (OSA)NCT07184060
Echocardiographic Assessment of Pulmonary Hypertension in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA) and Pulmonary Hypertension, run by Assiut University.
Trial summary
This study investigates the association between obstructive sleep apnea (OSA) and pulmonary hypertension (PH), focusing on the relationship between OSA severity and pulmonary arterial pressures in adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Pulmonary Hypertension
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2025to 30 Aug 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.
Who may be able to join
- Adults aged 18-65 years
- Diagnosed with obstructive sleep apnea (OSA) by full-night polysomnography
- Apnea-Hypopnea Index (AHI) ≥ 5 events/hour
Who cannot join
- Secondary pulmonary hypertension due to:Chronic pulmonary diseases, Left ventricular heart disease and Chronic thromboembolic disorders
- Use of pulmonary vasodilator therapy
- Long-term oxygen therapy (LTOT)
- Respiratory neuromuscular weakness
- Chest wall deformities
- End-organ failure (cardiac, renal, hepatic)
- Malignancy
- Obesity hypoventilation syndrome
About this study
Official title: A Prospective Observational Study on Pulmonary Hypertension in Patients With Obstructive Sleep Apnea: Correlation of Apnea-Hypopnea Severity With Pulmonary Artery Pressures
This study investigates the association between obstructive sleep apnea (OSA) and pulmonary hypertension (PH), focusing on the relationship between OSA severity and pulmonary arterial pressures in adult patients.
Read the detailed description
This prospective, observational, cross-sectional study will be conducted in the pulmonology and sleep medicine departments of Assiut University. Patients diagnosed with OSA through overnight polysomnography will be assessed for the presence and severity of PH using echocardiography. The study aims to determine whether OSA serves as an independent risk factor for PH and whether the severity of OSA, as measured by apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), correlates with echocardiographic indicators of PH. Data will be analyzed using standardized statistical methods to establish links between OSA severity and hemodynamic changes.
- Keywords
- obstructive sleep apnea, pulmonary hypertension
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with confirmed OSA | Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pulmonary Artery Pressure
The primary objective is to assess the presence and degree of pulmonary hypertension (measured by echocardiography) in OSA patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start30 Oct 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraqat Tony Badawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184060
- Sponsor's protocol ID
- Pulmonary Hypertension in OSA
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on Pulmonary Hypertension in Patients With Obstructive Sleep Apnea: Correlation of Apnea-Hypopnea Severity With Pulmonary Artery Pressures
- ClinicalTrials.gov ID
- NCT07184060
- Acronym / sponsor ID
- Pulmonary Hypertension in OSA
- Keywords
- obstructive sleep apnea, pulmonary hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
This study investigates the association between obstructive sleep apnea (OSA) and pulmonary hypertension (PH), focusing on the relationship between OSA severity and pulmonary arterial pressures in adult patients.
Detailed description
This prospective, observational, cross-sectional study will be conducted in the pulmonology and sleep medicine departments of Assiut University. Patients diagnosed with OSA through overnight polysomnography will be assessed for the presence and severity of PH using echocardiography. The study aims to determine whether OSA serves as an independent risk factor for PH and whether the severity of OSA, as measured by apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), correlates with echocardiographic indicators of PH. Data will be analyzed using standardized statistical methods to establish links between OSA severity and hemodynamic changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with confirmed OSA | – | –Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants are 18-65 years old and diagnosed with OSA (AHI ≥ 5 events/hour) confirmed through full-night polysomnographic sleep study. Patients will be stratified into mild (AHI 5-14), moderate (AHI 15-29), and severe OSA (AHI ≥ 30). Exclusion criteria include patients with secondary PH (from cardiac causes, chronic thromboembolic disease, or pulmonary conditions), chronic vasodilator therapy, long-term oxygen therapy, advanced organ failure, neuromuscular or chest wall deformities, obesity hypoventilation syndrome, or malignancy. The expected sample size is 55 patients, ensuring enough statistical power to detect associations. Demographic, clinical, echocardiographic, radiological, and sleep study parameters will be collected for each patient.
Key inclusion criteria (3 listed)
- Adults aged 18-65 years
- Diagnosed with obstructive sleep apnea (OSA) by full-night polysomnography
- Apnea-Hypopnea Index (AHI) ≥ 5 events/hour
Key exclusion criteria (8 listed)
- Secondary pulmonary hypertension due to:Chronic pulmonary diseases, Left ventricular heart disease and Chronic thromboembolic disorders
- Use of pulmonary vasodilator therapy
- Long-term oxygen therapy (LTOT)
- Respiratory neuromuscular weakness
- Chest wall deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Pulmonary Artery Pressure
Time frame: baseline
The primary objective is to assess the presence and degree of pulmonary hypertension (measured by echocardiography) in OSA patients.
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 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Pulmonary Hypertension, run by Assiut University.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Mean Pulmonary Artery Pressure (time frame: baseline). 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 19 Sep 2025.