Obstructive Sleep ApneaNCT05967754
Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome
A study testing polysomnography in people with Obstructive Sleep Apnea, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aimed to correlate serum uric acid levels and PAH in OSAHS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2020
- 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
- Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr)
- ≥18 years old.
Who cannot join
- Other sleep disorders as narcolepsy or hypersomnia were excluded as well as Patients with neuropsychiatric disorders.
- Hemodynamically unstable patients
- Patients with other chronic respiratory or cardiac diseases
- Patients with other known causes of pulmonary hypertension
- Patients with any disease or on medication that could alter excretion or urinary metabolism of uric acid such as Excessive uric acid production
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome
This study aimed to correlate serum uric acid levels and PAH in OSAHS patients.
Read the detailed description
Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension.
AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography. Patients were divided into three severity groups: mild OSA (5 ≤ AHI < 15), moderate OSA (15 ≤ AHI < 30), and severe (30 ≤ AHI < 60). Serum uric acid was measured the morning after polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery systolic pressure calculation was done.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDiagnostic test
polysomnography and serum uric acid measurement
| Study group | Role | What they receive |
|---|---|---|
| Patients with Obstructive sleep Apnea | Other | Patients with Obstructive sleep Apnea Receives: Diagnostic Test: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
Measured: one Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jan 2018
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ahmad Sweed, Alexandria University
- Investigators
- rania A SEWIED, doctor, Principal investigator, alex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967754
- Sponsor's protocol ID
- 24/327
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05967754
- Acronym / sponsor ID
- 24/327
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 1 Aug 2023 (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 aimed to correlate serum uric acid levels and PAH in OSAHS patients.
Detailed description
Obstructive sleep apnea-hypopnea syndrome is the most common form of SRBDs. Recurrent hypoxia, that accompanies OSAHS increases the degradation of ATP, which in turn increase uric acid concentration that can be used as a biomarker of tissue hypoxia in OSAHS. There is still debate about whether OSAHS is an independent contributor to pulmonary arterial hypertension.
AIM OF THE WORK This study aimed to correlate serum uric acid levels and PAH in OSAHS patients. Methods We enrolled 100 patients diagnosed with OSAHS using polysomnography. Patients were divided into three severity groups: mild OSA (5 ≤ AHI < 15), moderate OSA (15 ≤ AHI < 30), and severe (30 ≤ AHI < 60). Serum uric acid was measured the morning after polysomnography. All patients underwent standard echocardiograms, and Pulmonary artery systolic pressure calculation was done.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Obstructive sleep Apnea | Other | Diagnostic Test: polysomnographyPatients with Obstructive sleep Apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr)
- ≥18 years old.
Key exclusion criteria (5 listed)
- Other sleep disorders as narcolepsy or hypersomnia were excluded as well as Patients with neuropsychiatric disorders.
- Hemodynamically unstable patients
- Patients with other chronic respiratory or cardiac diseases
- Patients with other known causes of pulmonary hypertension
- Patients with any disease or on medication that could alter excretion or urinary metabolism of uric acid such as Excessive uric acid production
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 |
|---|---|---|
| polysomnographypolysomnography and serum uric acid measurement | Diagnostic test | Patients with Obstructive sleep Apnea |
Primary outcome
This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
Time frame: one Year
This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
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Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
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Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
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Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
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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.
rania A SEWIED, doctor principal investigator
alex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Obstructive Sleep Apnea, run by Alexandria University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 1 Aug 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
This study aimed to correlate serum uric acid levels and Pulmonary Arterial Hypertension in Obstructive Sleep Apnea Hypopnea Syndrome patients. (time frame: one Year). 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 1 Aug 2023.