Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05435001
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-06-22
Brief Title:
Screening of Sleep Apnea by Holter Electrocardiography Validation of Heart Rate Variability Analysis Algorithm
Sponsor:
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Organization:
Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 heldAbnormalities 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 accuracyFor 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 hospitals 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 andor 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
The patients were recruited from individuals referred to our university hospitals 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None