- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05435001
Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep Z Ucar, Prof Dr
- Phone Number: 2524 +902324333333
- Email: zeynepzucar@yahoo.com
Study Locations
-
-
-
İzmir, Turkey, 35110
- Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OSAS disease status
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: 24 hour
|
The variation in time intervals between heart beats.
HRV analysis (in time, frequency and nonlinear domains) with 2-channel Holter ECG monitoring.
|
24 hour
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zeynep Z Ucar, Prof Dr, Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGHCEAH-KAEK-139-2022730-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Apnea Syndromes
-
Tampere University HospitalActive, not recruiting
-
Sheffield Children's NHS Foundation TrustCompletedSleep Apnea Syndromes in ChildrenUnited Kingdom
-
University Hospital, AngersCompletedCancer | Sleep Apnea Syndromes, ObstructiveFrance
-
ResMedCRI-The Clinical Research Institute GmbH; University Hospital RegensburgCompletedObstructive Sleep Apnea | Central Sleep Apnea | Mixed Sleep Apnea | Complex Sleep ApneaSwitzerland, Spain, Denmark, Portugal, France, Germany
-
Hillel Yaffe Medical CenterUnknownSleep Apnea Syndromes, ObstructiveIsrael
-
University Hospital, GrenobleIcadom; DOCAPOST; SunriseCompletedSleep Apnea Syndrome, ObstructiveFrance
-
Democritus University of ThraceRecruitingConcentration Ability Impaired | Sleep Apnea Syndrome, Obstructive | Blinking | Pupil Diameter | DrowsinessGreece
-
Poitiers University HospitalCompletedObstructive Sleep Apnea Syndromes
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
Clinical Trials on Holter ECG Monitoring
-
Medical University of WarsawUnknownHeart Failure | Myocarditis | Sudden Cardiac Death | Cardiomyopathy | Arrythmia | Biomarker | Endomyocardial BiopsyPoland
-
Keimyung University Dongsan Medical CenterMinistry of Trade, Industry & Energy, Republic of Korea; Korea Evaluation Institute... and other collaboratorsCompletedAtrial Fibrillation | Arrhythmias, CardiacKorea, Republic of
-
Medical University of GrazRecruitingAtrial Fibrillation | ICD | Pacemaker DddAustria
-
Herlev HospitalCompletedStroke | Atrial FibrillationDenmark
-
Institute of Cardiology, Warsaw, PolandUnknownCardiac Arrhythmia | Cardiogenic SyncopePoland
-
Alfried Krupp KrankenhausRecruitingAtrial Fibrillation | Transient Ischemic AttackGermany
-
Nowodworskie Centrum MedyczneMedical University of WarsawCompletedObstructive Sleep Apnea | Obesity, Abdominal | Heart Rhythm Disorder
-
Vilnius UniversityKaunas University of TechnologyCompletedAtrial FibrillationLithuania
-
Institute of Cardiology, Warsaw, PolandUnknownArrhythmia | ChildrenPoland