Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome

• ClinicalTrials.gov Identifier: NCT05967754
• Recruitment Status: Completed
• First Posted: August 1, 2023
• Last Update Posted: August 1, 2023
• Sponsor: Alexandria University
• Information provided by (Responsible Party): Rania Ahmad Sweed, Alexandria University

Tracking Information

• First Submitted Date: July 15, 2023
• First Posted Date: August 1, 2023
• Last Update Posted Date: August 1, 2023
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Correlation Between Serum Uric Acid and Pulmonary Hypertension in Obstructive Sleep Apnea Syndrome
• Official Title: Correlation Between Serum Uric Acid and Pulmonary Arterial Hypertension Based on Echo Probability in Patients With Obstructive Sleep Apnea Syndrome
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Obstructive Sleep Apnea

Intervention

Diagnostic Test: polysomnography

polysomnography and serum uric acid measurement

Study Arms

Patients with Obstructive sleep Apnea

Patients with Obstructive sleep Apnea

Intervention: Diagnostic Test: polysomnography

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2023): 100
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 1, 2020
• Actual Primary Completion Date: October 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Clinical diagnosis of OSAHS by overnight polysomnography (AHI ≥ 5/ hr)
• ≥18 years old.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05967754
• Other Study ID Numbers: 24/327
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rania Ahmad Sweed, Alexandria University
• Original Responsible Party: Same as current
• Current Study Sponsor: Alexandria University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: rania A SEWIED, doctor; alex

• PRS Account: Alexandria University
• Verification Date: July 2023