The Epidemiology of Sleep Disordered Breathing in Patients With Congestive Heart Failure

February 13, 2024 updated by: ALBERT ANTHONY, Ministry of Health, Malaysia

The Epidemiological Characteristics of Sleep Disordered Breathing in Patients With Reduced or Preserved Ejection Fraction Congestive Heart Failure

This research will be one of the first hospital-based studies to comprehensively evaluate the epidemiological characteristics of sleep disordered breathing (SDB) in patients with Congestive Heart Failure (CHF). This prospective, observational cohort, single center study will include all consecutive CHF outpatients from the specialized heart failure clinic in Medical Department, Hospital Taiping, Malaysia irrespective of preserved or depressed Left Ventricular Ejection Fraction (LVEF). All participants will be subjected to an attended in-laboratory polysomnogram (PSG). It is anticipated the frequency and types of SDB to be variable compared to western data as this subject remains understudied in the South East Asian population. This research utilizes PSG rather than Portable Sleep Testing (PST) as seen in preceding studies for the diagnosis of SDB to prevent underdiagnosing SDBs and clearly distinguishing Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The epidemiology of SDB in CHF has not been studied in a South East Asian population. The results from studies conducted in USA and Europe on the prevalence of SDB in CHF may not be applicable to these patients for various reasons. Firstly, a diverse and multi -ethnic population in South East Asia may have an impact on the occurrence of SDB due to varying craniofacial morphological appearances, differences in levels of obesity and respiratory chemosensitivity. Additionally, the disparity in health services and the socio-economic differences between developed countries in the west and developing nations in South East Asia may have an impact on pharmacotherapy of CHF affecting the frequency and severity of SDB in these patients.

This research studies the epidemiological characteristics of SDB in non-selected, consecutive and consenting patients with CHF in the heart failure clinic as studying highly selected patients with clinical characteristics and risk factors of SBD may overestimate the prevalence. As patients with SDB in CHF may lack subjective EDS and assessment tools are unreliable in predicting SDB in CHF patients, the investigators wish to identify clinical predictors in this cohort of patients. It is anticipated there may be differences in this aspect when compared to patients in the western population and the investigators hope to obtain some understanding on the gender differences for SDB that has been reported in prior studies as well. The utility of attended in laboratory PSG as a diagnostic tool for all consecutive patients with CHF will prevent underestimation of AHI and clearly distinguish OSA and CSA based on standard definitions.

The prevalence of SDB in preserved ejection fraction CHF is understudied globally and the investigators wish to include preserved ejection fraction CHF patients apart from depressed ejection fraction CHF patients in this study. SDB presents as a treatment opportunity for patients with CHF but first the disorder has to be suspected and diagnosed. Initiation of nocturnal ventilation following diagnosis may treat the SDB and improve the prognosis of CHF.

Study Type

Observational

Enrollment (Actual)

116

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

  • Malaysia
    • Perak
      • Taiping, Perak, Malaysia, 34000
        • Hospital Taiping

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

All consecutive adult patients under follow-up in Heart Failure Clinic, Hospital Taiping during the period 1 April 2022 - 31 December 2024

Description

Inclusion Criteria:

  • All patients with CHF regardless of LVEF Participants need to be older than 18 years old and is able to understand study information and give informed consent

Exclusion Criteria:

  • Patients who had been diagnosed with SDB or is treated with any form of Positive Airway Pressure (PAP) therapy prior to this will be excluded from this 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic Heart Failure Patients
All patients in our specialised heart failure clinic will be screened by the investigator/s.
Diagnostic test: Full Polysomnography
Overnight PSG will be conducted using Alice version 6 system (Respironics, Pittsburgh, PA, USA). During PSG, the following variables will be monitored and captured. Sleep staging using electroencephalogram (four channels: C3-A2, C4-A1, O1-A2, O2-A1), electrooculogram (two channels: LOC-A2, ROC-A1), electromyogram (two channels: submental and anterior tibialis muscles). Respiratory effort using inductive plethysmograph sensors to detect thoracoabdominal movements. Oro-nasal airflow using pressure flow transducer and thermistor. Oxygen saturation using pulse oximetry and cardiac rhythm using electrocardiography. Other parameters that will also be monitored includes body position, presence of snoring and end tidal CO2 (EtCO2) measurement to detect hypercapnia. The attended PSG will be conducted in the sleep laboratory in Respiratory Unit, Hospital Taiping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Sleep Disordered Breathing
Time Frame: through study completion, an average of 2 years
Present or Absent
through study completion, an average of 2 years
Type of Sleep Disordered Breathing
Time Frame: through study completion, an average of 2 years
Obstructive or Central Sleep Apnoea
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Ministry of Health, Malaysia

Investigators

  • Principal Investigator: ALBERT IRUTHIARAJ L. ANTHONY, MBBS, Hospital Taiping

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 15, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR ID-22-00210-Y9W (IIR)

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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