Completed

Evolution of a New Algorithm of Heart Rate Variability Analysis From Two-channel Holter Electrocardiogram in Pre-diagnosis of Obstructive Sleep Apnea Syndrome: a Study on Diagnostic Accuracy

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What is being tested

Holter ECG Monitoring

Device
Who is being recruted

Apnea+5

+ Nervous System Diseases

+ Respiration Disorders

From 18 to 80 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorIzmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 5, 2022

Actual date on which the first participant was enrolled.

To find out whether a new algorithm of HRV analysis from holter ECG monitoring can be used as a screening test for the diagnosis of patients with moderate-to-severe risk of obstructive sleep apnea syndrome (OSAS) with an acceptable accuracy.For this, overnight sleep pattern will be investigated in at least 107 individuals by polysomnography and 24-h ambulatory electrocardiography. Heart rate variability sleep apnea risk score (HRV-SARS) will be calculated using HRV analyses. The patients were recruited from individuals referred to our university hospital's sleep center for a polysomnography recording because of clinically suspected OSAS (with at least one of the following obstructive sleep apnea symptoms: witnessed apnea, snoring and/or daytime sleepiness) from May to July 2022. Prospectively 107 patients enrolled in the study according to inclusion and exclusion criteria. Exclusion criteria were permanent or paroxysmal atrial fibrillation, permanent pacemaker, history of other sleep disorders, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments. All patients underwent both a full polysomnography recording and ECG Holter monitoring. This new algorithm of HRV analysis from holter ECG monitoring may represent an accurate and inexpensive screening tool in clinically suspected OSAS patients and may help focus resources on those at the highest risk.

Official TitleEvolution of a New Algorithm of Heart Rate Variability Analysis From Two-channel Holter Electrocardiogram in Pre-diagnosis of Obstructive Sleep Apnea Syndrome: a Study on Diagnostic Accuracy
NCT05435001
Principal SponsorIzmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

1 inclusion criteria required to participate
The patients will be recruited from individuals referred to our university hospital's sleep center for a polysomnography recording because of clinically suspected OSAS (with at least one of the following obstructive sleep apnea symptoms: witnessed apnea, snoring and/or daytime sleepiness)

1 exclusion criteria prevent from participating
Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The dependent variable was diseased status (OSAS +/-). The independent variables analyzed were age, sex, body mass index (BMI), and for HRV variables, their day and night values and the differences between their night and day values (D\[D/N\]), as night mean HR, D\[D/N\] mean HR, night r-MSSD, D\[D/N\] r-MSSD, night SDNN, D\[D/N\] SDNN, night SDNN index, D\[D/N\] SDNN index, night SDANN, and D\[D/N\] SDANN.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital

Izmir, Turkey (Türkiye)Open Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital in Google Maps
CompletedOne Study Center