New Perspective on Exploring the Post-apneic BP Surge in Patients With OSA

December 14, 2023 updated by: Xu J

New Perspective on Exploring the Post-apneic Blood Pressure Surge in Patients With Obstructive Sleep Apnea

The nocturnal short-term BPV induced by sleep-breathing events is affected by many factors. The purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It has been known that nocturnal short-term blood pressure variability (BPV) is a special phenomenon in obstructive sleep apnea (OSA) patients. Nocturnal short-term BPV is a quantitative measure that describes the BP fluctuation over a period of seconds to minutes. It is significantly associated with target organ injury, increased risk of cardio-cerebrovascular events, and increased mortality, independent of mean BP level. Our prior study found that nocturnal BP will temporarily reach the peak during one OSA episode and come to decline rapidly. However, this phenomenon does not occur in all OSA patients. In some severe OSA patients with severe hypoxemia, their BP can still maintain a relatively stable level when one OSA episode. The specific mechanism is still unclear. In physiological conditions, the BP fluctuation caused by each cardiac cycle is affected by vascular function, central sympathetic, arterial reflex, cardiopulmonary reflex, elastic properties of arteries, humoral, and even emotional factors. Therefore, the purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

First, about 300 suspected OSA and 50 healthy subjects under full-night polysomnography (PSG) will be recruited in the sleep medicine center of The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University and The First Affiliated Hospital with Nanjing Medical University. All the participants complete the questionnaire which includes clinical medical history, sleep habits, general health, smoking and drinking history, and anthropometric data. When PSG worked, BP was calculated by pulse transit time (PTT) simultaneously and continuously. The electrocardiography data extracted from the entire overnight PSG recordings are visually inspected for accuracy and quality and used for heart rate analysis (HRV) analysis. The next day, 4-5 mL peripheral venous blood samples are obtained from participants in the morning after an overnight fast and used for biochemical analysis. The sympathetic activity could be represented by HRV and Norepinephrine detected by enzyme-linked immunosorbent. Then, brachial artery diameter will be measured after the reactive hyperemia (called flow-mediated dilation, FMD) and nitroglycerin stimulus (called nitroglycerin-mediated dilation, NMD). The FMD and NMD could represent the vascular function. About 80 patients will be in the next plan. On the second day, under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. On the third day, under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction. The parameters before and after medicine will be analyzed and compared.

Hypothesis: The investigator predicted that patients who received phentolamine and nitroglycerin injections would lower nocturnal short-term BPV measured by polysomnography

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Jing Xu
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • medium to severe OSA (apnea-hypopnea index, AHI≥15 events/h) and patients without OSA (AHI<5 events/h)
  • age from 18 to 65 years old.

Exclusion Criteria:

  • combined with other sleep disorders
  • patients with comorbidities, such as hypertension, diabetes, cardiovascular diseases, and cerebrovascular diseases etc
  • conditions that potentially affect the accuracy of BPV and endothelial function
  • ever-received the treatment of constructive positive airway pressure (CPAP)
  • who refuse to participate in the study.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: healthy subject
No Intervention: low BPV group
Experimental: high BPV group
Drug: Phentolamine Injection
Under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. Under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction.
Other Names:
  • Nitroglycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with high nocturnal short-term BPV will change
Time Frame: one night
one night

Collaborators and Investigators

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

Sponsor

Xu J

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)

April 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 26, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huaian1PH8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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