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Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm

Primary Purpose

Sleep Apnea Syndromes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Holter ECG Monitoring
Sponsored by
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea Syndromes focused on measuring Heart rate variability, Holter ECG monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OSAS disease status

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart Rate Variability
The variation in time intervals between heart beats. HRV analysis (in time, frequency and nonlinear domains) with 2-channel Holter ECG monitoring.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
February 19, 2023
Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Collaborators
Amatis Software and Fysiologic Smart ECG Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT05435001
Brief Title
Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Collaborators
Amatis Software and Fysiologic Smart ECG Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea syndrome (OSAS) is a growing health concern affecting up to 60 % of population with cardiovascular disease. Despite the high cardiovascular morbidity and mortality associated with this syndrome, the substantial inconvenience and cost of polysomnography recordings may delay routine evaluation. Polysomnography (PSG) is the gold standard for diagnosis. However, this is a costly and time-consuming examination. Sympathoadrenergic balance obtained from the routine Holter monitoring suggesting the presence of OSAS, can enable patients to be guided and their PSGs to be primarily held.Abnormalities in nocturnal cyclical heart rate (HR) variations have previously been described in sleep-related breathing disorders. Compared with PSG, holter electrocardiogram has the advantages of pervasion, lower cost, no need for overnight hospitalization, greater similarity to normal conditions, and good compliance. The observation of changes in heart rate associated with apneic events has a potential to be used as an alternative technique for identification of subjects with OSAS. In regard to the feasibility of screening OSAS by HRV analysis by holter electrocardiogram monitoring, it has already been reported that a 24-h electrocardiographic monitoring might be useful to diagnose OSAS. It became a more feasible technique to use following the development of a convenient recorder for OSAS screening by analyzing changes in heart rate.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Heart rate variability, Holter ECG monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSAS disease status
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Holter ECG Monitoring
Intervention Description
Holter electrocardiogram monitoring will be carried out for 24 h simultaneously with the PSG monitoring using a 2- lead ambulatory electrocardiograph (Fysiologic; kind courtesy: MedTech Company, Amsterdam, Holland). We will calculate the time-domain, frequency-domain and non-linear indices by HRV. Several parameters describing the differences between RR intervals will be calculated: the square root of the mean of the sum of the squares of differences between adjacent normal RR intervals (r-MSSD), SD of NN intervals (SDNN), SD of the averages of NN intervals in all 5-minute segments of the recording (SDANN), and mean of the SD of all NN intervals for all consecutive 5-minute segments of the recording (SDNN index). All variables will be calculated for the 24-hour, daytime (2:00 to 9:00 PM), and nighttime (midnight to 7 AM) periods, and the differences between daytime and nighttime values (D[D/N]) will be computed.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
The variation in time intervals between heart beats. HRV analysis (in time, frequency and nonlinear domains) with 2-channel Holter ECG monitoring.
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Z Ucar, Prof Dr
Organizational Affiliation
Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
City
İzmir
ZIP/Postal Code
35110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm

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