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

NCT05332223 | Completed DMC

• 1 other identifier: NMRR ID-22-00210-Y9W (IIR)
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Heart Failure; Sleep Disorder

Keywords

Chronic Heart Failure; Sleep Disorder

Outcome Measures

Primary Outcomes (2)

• Presence of Sleep Disordered Breathing

  Present or Absent

  through study completion, an average of 2 years

• Type of Sleep Disordered Breathing

  Obstructive or Central Sleep Apnoea

  through study completion, an average of 2 years

Study Arms (1)

Chronic Heart Failure Patients

All patients in our specialised heart failure clinic will be screened by the investigator/s.

Diagnostic Test: Full Polysomnography

Interventions

Full Polysomnography DIAGNOSTIC_TEST

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

Chronic Heart Failure Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Hospital Taiping

Taiping, Perak, 34000, Malaysia

Location

Related Publications (6)

• Arzt M, Young T, Finn L, Skatrud JB, Ryan CM, Newton GE, Mak S, Parker JD, Floras JS, Bradley TD. Sleepiness and sleep in patients with both systolic heart failure and obstructive sleep apnea. Arch Intern Med. 2006 Sep 18;166(16):1716-22. doi: 10.1001/archinte.166.16.1716.

  PMID: 16983049 BACKGROUND

• Arzt M, Woehrle H, Oldenburg O, Graml A, Suling A, Erdmann E, Teschler H, Wegscheider K; SchlaHF Investigators. Prevalence and Predictors of Sleep-Disordered Breathing in Patients With Stable Chronic Heart Failure: The SchlaHF Registry. JACC Heart Fail. 2016 Feb;4(2):116-125. doi: 10.1016/j.jchf.2015.09.014. Epub 2015 Dec 9.

  PMID: 26682790 BACKGROUND

• Collop NA, Anderson WM, Boehlecke B, Claman D, Goldberg R, Gottlieb DJ, Hudgel D, Sateia M, Schwab R; Portable Monitoring Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2007 Dec 15;3(7):737-47.

  PMID: 18198809 BACKGROUND

• Chan J, Sanderson J, Chan W, Lai C, Choy D, Ho A, Leung R. Prevalence of sleep-disordered breathing in diastolic heart failure. Chest. 1997 Jun;111(6):1488-93. doi: 10.1378/chest.111.6.1488.

  PMID: 9187161 BACKGROUND

• Joynt KE, Jha AK. Who has higher readmission rates for heart failure, and why? Implications for efforts to improve care using financial incentives. Circ Cardiovasc Qual Outcomes. 2011 Jan 1;4(1):53-9. doi: 10.1161/CIRCOUTCOMES.110.950964. Epub 2010 Dec 14.

  PMID: 21156879 RESULT

• Lourdesamy Anthony AI, Abdul Rani R. The epidemiological characteristics of sleep disordered breathing in congestive heart failure: A prospective, single centre study in Southeast Asia. J R Coll Physicians Edinb. 2024 Mar;54(1):18-25. doi: 10.1177/14782715241239704. Epub 2024 Mar 20.

  PMID: 38509698 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• ALBERT IRUTHIARAJ L. ANTHONY, MBBS

  HOSPITAL TAIPING

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 18, 2022
• Study Start: April 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)