Predictive Value of Sleep Apnea-specific PTT Response for Incident Subclinical Abnormalities in LV Structure and Function in Cohort of moderate-to Severe OSA

October 3, 2024 updated by: Xu J

Predictive Value of Sleep Apnea-specific Pulse Transit Time Response for Incident Subclinical Abnormalities in Left Ventricle Structure and Function in Cohort of moderate-to Severe Obstructive Sleep Apnea

This observational study aims to provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice. The main question it aims to answer is:

Could acute PTT response surrounding obstructive respiratory events predict the incidence of subclinical abnormalities in LV structure and function in moderate-to-severe OSA patients? Participants who had undergone standard polysomnography and were diagnosed with moderate-to-severe OSA 5 years ago were required to complete the cardiac remodeling and function evaluation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive sleep apnea (OSA) is a widely prevalent medical condition characterized by recurrent upper airway obstruction with intermittent hypoxia, sleep disruption, and increased ventilation. Serial studies have shown that OSA promotes oxidative stress, sympathetic activity, and intrathoracic pressure fluctuation, resulting in adverse cardiac structures and function. The cumulative data from observational studies have linked the apnea-hypopnea index (AHI), an indicator of OSA severity, with increased LV injury. As OSA is a highly heterogeneous disorder, with diverse pathways to disease, expression of disease, susceptibility to co-morbidities, and response to therapy. Hence, OSA is ideally suited to precision medicine approaches. While the current assessment relies on the AHI, this traditional metric poorly reflects the complex pathophysiological of OSA on cardiac injury.

Asymptotic cardiac dysfunction is not easily identified, and many sufferers remain undiagnosed in clinical practice. Focusing on recognition and treatment of subclinical cardiac injury early is a potentially powerful strategy to prevent progression to clinical or symptomatic heart failure. In OSA patients, the BP and heart rate (HR) changes occurring with obstructive events involve an initial decrease early in the event, a gradual increase during the terminal portion of the event, and an immediate surgeon resumption of ventilation. These acute hemodynamic and autonomic changes may be closely associated with the development and progression of cardiovascular disease. Whether this OSA-specific cardiovascular reactivity pattern is the potentially early warning indicator of cardiac injury is unknown.

A physiologic parameter termed pulse transit time (PTT) has been studied intensively as an indirect marker for variations in cardiovascular-related reactivity. It can be generally referred to as the time difference for a pulse wave to travel between two arterial sites. The speed at which this arterial pressure wave travels was used to assess nocturnal blood pressure variation, arterial stiffness changes, autonomic nervous response, and inspiratory effort. More experimentally focused investigations with PTT as a key measure in cardiovascular-related studies are being reported.

In the present study, the investigators examined acute PTT changes surrounding obstructive events, for PTT can be easily measured in standard polysomnography (PSG). The investigators hypothesized that the specific respiratory events PTT response would predict incident subclinical abnormalities in LV structure and function in a cohort of moderate-to-severe OSA without other confounded morbidities. The results of this study provide evidence for identifying those who mostly suffer from LV injury and will help construct an optimal strategy for clinical practice.

Study Type

Observational

Enrollment (Actual)

376

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

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients aged 18 years and older, with moderate-to-severe OSA, who were diagnosed between January 1 2014, and December 31 2019 at The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, the First Affiliated Hospital of Nanjing Medical University, and the Affiliated Hospital of Xuzhou Medical University.

Description

Inclusion Criteria:

  1. ≥18 years old;
  2. Moderate to severe OSA(AHI≥15 times/hour).

Exclusion Criteria:

  1. baseline hypoxia;
  2. other sleep disorders;
  3. received regular CPAP treatment(on average of ≥ 4 hours for CPAP use per night during the retrospective period);
  4. the prevalent diseases at baseline might have influenced the results of echocardiographic results: hypertension chronic atrial fibrillation, atrioventricular block, bundle branch blocks, a permanent pacemaker, heart failure, valvular heart disease, pulmonary emboli, abnormal thyroid function, cardiomyopathies, pulmonary hypertension, use of digitalis, use of antiarrhythmic agents, use of beta-blockers, or use of calcium agonists affecting heart rate (HR), including verapamil and diltiazem.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the cardiac remodeling evaluation
Time Frame: from October 2023 to May 2024

The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines.

Measures of LV remodeling included LV end-systolic (LVDs) in centimeters, and end-diastolic diameter (LVDd) in centimeters, interventricular septum thickness at end-diastole (IVSd) in centimeters, LV mass (LVM) in grams. LVM (LVMI) was calculated as the ratio of LVM in grams and body surface area in square meters. LVH was defined as an LVMI of 111 g/m2or 50 g/m2 in males and of 106 g/m2or 47 g/m2 in females.
from October 2023 to May 2024
the cardiac function evaluation
Time Frame: from October 2023 to May 2024

The echocardiogram was carried out using machines equipped with a 2.5-MHz probe. All 2D and Doppler images and measurements were obtained in agreement with the European Association of Echocardiography/American Society of Echocardiography guidelines.

Measures of LV diastolic function included the average of the septal and lateral mitral annular descent tissue Doppler velocity (E') in cm/s, early mitral inflow velocity E' in cm/s, and the ratio of E/E'. Measures of systolic function included LV ejection fraction (EF) in percentage using Simpson biplane method of disks in 2-chamber and 4-chamber apical views (a single view was used in cases where one view was technically suboptimal).
from October 2023 to May 2024

Collaborators and Investigators

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

Sponsor

Xu J

Collaborators

The Affiliated Hospital of Xuzhou Medical University
The first affiliated Hospital of Nanjing Medical University, Jiangsu Province

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)

January 1, 2014

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YX-Z-2023-027-01

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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