Sleep Apnea SyndromesNCT05435001
Screening of Sleep Apnea by Holter Electrocardiography: Validation of Heart Rate Variability Analysis Algorithm
A study testing Holter ECG Monitoring in people with Sleep Apnea Syndromes, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Holter ECG Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
Izmir, 35110
About this study
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
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.
Read the 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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Holter ECG Monitoring
- Keywords
- Heart rate variability, Holter ECG monitoring
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter ECG MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OSAS disease status | 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. Receives: Device: Holter ECG Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start5 May 2022
- Primary completion1 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amatis Software and Fysiologic Smart ECG Solutions
- Responsible party
- Principal investigator, Zeynep Zeren Ucar, Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Investigators
- Zeynep Z Ucar, Prof Dr, Principal investigator, Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435001
- Sponsor's protocol ID
- IGHCEAH-KAEK-139-2022730-35
- Status last verified
- Feb 2023
- First submitted
- 22 Jun 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05435001
- Acronym / sponsor ID
- IGHCEAH-KAEK-139-2022730-35
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Heart rate variability, Holter ECG monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Collaborators
- Amatis Software and Fysiologic Smart ECG Solutions
- Study start
- 5 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAS disease status | Experimental | Device: Holter ECG MonitoringThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Permanent or paroxysmal atrial fibrillation, permanent pacemaker, severe cardiopulmonary disease, severe diabetes mellitus, autonomic dysfunction or major physical or mental ailments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter ECG MonitoringHolter 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. | Device | OSAS disease status |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Z Ucar, Prof Dr principal investigator
Izmir Dr Suat Seren Chest Disease and Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holter ECG Monitoring in people with Sleep Apnea Syndromes, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.