Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With OSAS

March 19, 2024 updated by: Xu J, Huai'an No.1 People's Hospital

Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With Obstructive Sleep Apnea Syndrome

It is thought that intermittent hypoxia, poor tissue oxygenation, and perfusion in OSA can lead to eNOS uncoupling. Uncoupled eNOS can reduce nitric oxide (NO), which will result in an imbalance of contraction and diastole. Furthermore, OSA may increase beat-to-to BPV via the characteristic acute blood pressure peaks that follow the end of obstructive apnoeas. Therefore, the aim is to discuss the relationship between vascular endothelial dysfunction and beat-to-beat blood pressure variability in patients with OSAS (Obstructive sleep apnea syndrome).

Study Overview

Status

Recruiting

Conditions

Detailed Description

Obstructive sleep apnea (OSA) is characterized by recurrent airway collapse that causes chronic intermittent hypoxia(CIH). OSA is associated with systemic inflammation and oxidative stress resulting in endothelial dysfunction and cardiovascular disease (CVD). Under physiological conditions, eNOS is activated by shear stress and Ach. L-arginine and O2 are catalyzed by BH4, FMN, FAD, NADPH, and eNOS to produce nitric oxide (NO)， which has an important vasodilating effect， and L-citrulline. During the episode of OSA, intermittent hypoxia leads to oxidative stress resulting in the production of superoxide anions. The reaction between O2- and NO occurs rapidly, resulting in ONOO-. ONOO- and H2O2 oxidize BH4 to dihydrobiotrexate (BH2), which is a competitive inhibitor with BH4, thus limiting the availability of eNOS substrates and preventing NO production, resulting in an imbalance between contraction and diastolic. It has been documented that beat-to-beat blood pressure variability in OSAS patients is much higher than that in healthy adults. In some patients, intermittent hypoxia was observed with the episode of OSA, and blood pressure fluctuated with the episode of hypoxia. However, this was not found in the other patients, whose blood pressure did not change significantly during the hypoxia episode. Therefore, the investigators considered that the endothelial function of patients with high sensitivity to hypoxia was healthy or in the early stage, while the endothelial function of those patients with low sensitivity to hypoxia was at a relatively high level of impairment. Endothelial dysfunction can be measured indirectly by brachial artery flow-mediated dilation (FMD), beat-to-beat blood pressure variability can be measured by Polysomnography (PSG), and biological examinations can be performed by blood sampling. Thus, the purpose is to explore the specific relationship between OSAS beat-to-beat blood pressure variability and endothelial dysfunction.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Outpatient snoring patients will have PSG, and patients aged 18 years and older will be included in the study.Inclusion Criteria:1. Moderate to severe OSA(AHI≥15 times/hour);2. Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);Exclusion Criteria:1.Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes 2.Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg 3.Vigorous exercise 24 hours before the experiment; 4.Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;

Description

Inclusion Criteria:

  1. ≥18 years old;
  2. Moderate to severe OSA(AHI≥15 times/hour);
  3. Hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg);

Exclusion Criteria:

  1. Malignant tumor, severe arrhythmia and heart disease, moderate and severe renal dysfunction, peripheral vascular disease, diabetes
  2. Systolic blood pressure ≤140mmHg and diastolic blood pressure ≤90mmHg
  3. Vigorous exercise 24 hours before the experiment;
  4. Vasoactive drugs (ACEI, ARB, CCB, β blockers, nitrates) were used 48 hours before the experiment;
  5. Smoking, drinking and consuming caffeinated beverages 12 hours before the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship Between Vascular Endothelial Dysfunction and Beat-to-beat Blood Pressure Variability in Patients With OSAS
Time Frame: 2022.04.01-2023.04.01
the endothelial dysfucntion patients with OSAS have more sever blood pressure variability
2022.04.01-2023.04.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huai'an No.1 People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huaian1PH3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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