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

NCT05332223 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 116

Last updated 2024-02-15

No results posted yet for this study

Summary

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • ALBERT IRUTHIARAJ L. ANTHONY, MBBS · HOSPITAL TAIPING

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05332223 on ClinicalTrials.gov