Obstructive Sleep ApneaNCT04621032
Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity
An observational study of Obstructive Sleep Apnea and Heart Rhythm Disorder, run by Nowodworskie Centrum Medyczne.
Trial summary
Literature shows that patients with obesity and Obstructive Sleep Apnea (OSA), both occurring independently, are more likely to develop cardiovascular diseases and sudden cardiac death (SCD). Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea, Heart Rhythm Disorder, Obesity, Abdominal
- What is being tested?
- Polygraphy monitoring and laboratory tests
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 31 Aug 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.
Who may be able to join
- gender: female or male,
- age 35-65 years old,
- visceral obesity,
- lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders,
- not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)],
- not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination.
Who cannot join
- revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics,
- revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg,
- revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible,
- too short total sleep time (< 6 hours) registered on polygraphy.
About this study
Literature shows that patients with obesity and Obstructive Sleep Apnea (OSA), both occurring independently, are more likely to develop cardiovascular diseases and sudden cardiac death (SCD). Assuming that ventricular depolarization is more stable than repolarization then QT interval parameters may be used for heart muscle repolarization assessment for those groups of patients.
There were 121 patients included in the study, both - women and men, aging from 35-65 with visceral obesity. Only healthy patients were included - the ones who were not treated for any chronic disease, taking QT elongating drugs, or were not treated with Continuous Positive Airway Pressure (CPAP) therapy at that time.
Read the detailed description
The current study was a prospective, observational clinical trial performed between September 2016 and August 2019 at a single-center institution specializing in treatment of patients with obstructive sleep apnea. The inclusion criteria were as follows: (1) gender: female or male, (2) age 35-65 years old, (3) visceral obesity, (4) lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders, (5) not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)], (6) not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination. Patients, who met all inclusion criteria, underwent subject and physical examination, an over-night Holter-ECG, polygraphy and laboratory biochemical tests (sodium, potassium, calcium, magnesium concentration and fasting glyceamia.
Enrolled patients were asked questions about general frame of mind, daytime and nighttime symptoms that may suggest OSA [according to Epworth Sleepiness Scale (https://epworthsleepinessscale.com/about-the-ess/ access date 08 May 2020)]. All patients were fully physically examined. Neck and waist circumference were measured according to STEPwise Approach to Surveillance (STEPS) by WHO (https://www.who.int/ncds/surveillance/steps/en/. [access date 23 April.2019]. Upon subject examination (snoring and choking feeling during the sleep) a corrected neck circumference was calculated.
Polygraphy was conducted using MED Recorder device by Infoscan company according to AASM guidelines (American Academy of Sleep Medicine, International classification of sleep disorders, 2016). The device registered blood saturation, heart rate, airflow, chest and abdomen movements, body position, snoring and single lead ECG. OSA was diagnosed according to AASM definition (American Academy of Sleep Medicine, Sleep-related breathing disorders in adults, 1999): in every patient with Respiratory Disturbance Index (RDI) ≥ 5/hour and with concomitant OSA sings (Epworth Sleepiness Scale ≥ 11 pts) or with RDI ≥ 15/hour. The minimum time of analyzed data without artifacts had to last at least 6 h.
A Holter-ECG examination was conducted using DMS 300-3A device by Oxford company suitable for Cardioscan 10 system. Registration was made simultaneously with polygraphy, during the night. Chosen QT interval assessment parameters were evaluated upon partially automatically analyzed fragments of ECG records. Only nighttime ECG records were analyzed due to maximum comparability (similar patient's physical activity and minimized, because of limited body movements, artifacts). Moreover, the study aimed to assess a heart's activity simultaneous to sleep breathing disorders. Only ECG strips with constant heart rate, optimally within 50-70/min limits, were chosen due to the minimum impact of such heart rate on QT interval correction formula. QTc data was calculated upon Bazett's formula. QTV and QTVi were calculated upon Berger's formula.
After getting all results they were checked against the following exclusion criteria: 1) revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics, 2) revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg, 3) revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible, 4) too short total sleep time (< 6 hours) registered on polygraphy.
Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.
- Being tested
- Polygraphy monitoring, laboratory tests
- Keywords
- Obstructive Sleep Apnea, QT interval, QTV, QTc, repolarisation homogeneity
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygraphy monitoringDiagnostic test
Also called Holter ECG monitoring
All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.
laboratory testsDiagnostic test
Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.
| Study group | Role | What they receive |
|---|---|---|
| OSA + | Patients with visceral obesity and newly diagnosed Obstructive Sleep Apnea (during the study) Receives: Diagnostic Test: Polygraphy monitoring; Diagnostic Test: laboratory tests | |
| OSA - | Patients with visceral obesity in whom Obstructive Sleep Apnea diagnosis have been excluded (during the study) Receives: Diagnostic Test: Polygraphy monitoring; Diagnostic Test: laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
A number of patients with visceral obesity and Obstructive Sleep Apnea
Polygraphy examination of each patient
Measured: one day per each patient
Secondary outcomes (2)
A number of patients with visceral obesity and heart rhythm disorders occurrence.
Holter-ECG monitoring of each patient
Measured: Holter ECG - one day per patient
Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients
statistical analysis
Measured: 2016-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Sep 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nowodworskie Centrum Medyczne
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Principal investigator, Aleksandra Jarecka-Dobroń, Nowodworskie Centrum Medyczne
- Investigators
- Aleksandra Jarecka-Dobroń, PhD, Principal investigator, NowodworskieMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621032
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For a reasonable request the principal intevstigator will share stastical data of studied group.
Publications
Alam I, Lewis MJ, Lewis KE, Stephens JW, Baxter JN. Influence of bariatric surgery on indices of cardiac autonomic control. Auton Neurosci. 2009 Dec 3;151(2):168-73. doi: 10.1016/j.autneu.2009.08.007. Epub 2009 Aug 31.
PubMed 197205692. American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed. Diagnostic and coding manual. Westchester, Illinois: American Academy of Sleep Medicine 2005. Updated November 2015. Darien, IL: American Academy of Sleep medicine, 2016.
Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
PubMed 10450601Arslan E, Yiginer O, Yavasoglu I, Ozcelik F, Kardesoglu E, Nalbant S. Effect of uncomplicated obesity on QT interval in young men. Pol Arch Med Wewn. 2010 Jun;120(6):209-13.
PubMed 20567204Barta K, Szabo Z, Kun C, Munkacsy C, Bene O, Magyar MT, Csiba L, Lorincz I. The effect of sleep apnea on QT interval, QT dispersion, and arrhythmias. Clin Cardiol. 2010 Jun;33(6):E35-9. doi: 10.1002/clc.20619.
PubMed 20552591Baumert M, Schlaich MP, Nalivaiko E, Lambert E, Sari CI, Kaye DM, Elser MD, Sanders P, Lambert G. Relation between QT interval variability and cardiac sympathetic activity in hypertension. Am J Physiol Heart Circ Physiol. 2011 Apr;300(4):H1412-7. doi: 10.1152/ajpheart.01184.2010. Epub 2011 Jan 21.
PubMed 21257917Baumert M, Porta A, Vos MA, Malik M, Couderc JP, Laguna P, Piccirillo G, Smith GL, Tereshchenko LG, Volders PG. QT interval variability in body surface ECG: measurement, physiological basis, and clinical value: position statement and consensus guidance endorsed by the European Heart Rhythm Association jointly with the ESC Working Group on Cardiac Cellular Electrophysiology. Europace. 2016 Jun;18(6):925-44. doi: 10.1093/europace/euv405. Epub 2016 Jan 27.
PubMed 26823389Baumert M, Smith J, Catcheside P, McEvoy RD, Abbott D, Sanders P, Nalivaiko E. Variability of QT interval duration in obstructive sleep apnea: an indicator of disease severity. Sleep. 2008 Jul;31(7):959-66.
PubMed 18652091Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.
PubMed 15788497Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
PubMed 23770166Haigney MC, Zareba W, Gentlesk PJ, Goldstein RE, Illovsky M, McNitt S, Andrews ML, Moss AJ; Multicenter Automatic Defibrillator Implantation Trial II investigators. QT interval variability and spontaneous ventricular tachycardia or fibrillation in the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II patients. J Am Coll Cardiol. 2004 Oct 6;44(7):1481-7. doi: 10.1016/j.jacc.2004.06.063.
PubMed 15464332Hinterseer M, Beckmann BM, Thomsen MB, Pfeufer A, Dalla Pozza R, Loeff M, Netz H, Steinbeck G, Vos MA, Kaab S. Relation of increased short-term variability of QT interval to congenital long-QT syndrome. Am J Cardiol. 2009 May 1;103(9):1244-8. doi: 10.1016/j.amjcard.2009.01.011. Epub 2009 Mar 18.
PubMed 1940626614. Report of a WHO Expert Consultation. Waist circumference and waist-hip ratio. Geneva, 8-11 Dec 2008.
Mathieu P, Poirier P, Pibarot P, Lemieux I, Despres JP. Visceral obesity: the link among inflammation, hypertension, and cardiovascular disease. Hypertension. 2009 Apr;53(4):577-84. doi: 10.1161/HYPERTENSIONAHA.108.110320. Epub 2009 Feb 23. No abstract available.
PubMed 19237685Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19.
PubMed 16424443
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea Destabilizes Myocardial Repolarization Homogeneity
- ClinicalTrials.gov ID
- NCT04621032
- Acronym / sponsor ID
- 1
- Keywords
- Obstructive Sleep Apnea, QT interval, QTV, QTc, repolarisation homogeneity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Nowodworskie Centrum MedyczneUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 9 Nov 2020 (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.
Literature shows that patients with obesity and Obstructive Sleep Apnea (OSA), both occurring independently, are more likely to develop cardiovascular diseases and sudden cardiac death (SCD). Assuming that ventricular depolarization is more stable than repolarization then QT interval parameters may be used for heart muscle repolarization assessment for those groups of patients.
There were 121 patients included in the study, both - women and men, aging from 35-65 with visceral obesity. Only healthy patients were included - the ones who were not treated for any chronic disease, taking QT elongating drugs, or were not treated with Continuous Positive Airway Pressure (CPAP) therapy at that time.
Detailed description
The current study was a prospective, observational clinical trial performed between September 2016 and August 2019 at a single-center institution specializing in treatment of patients with obstructive sleep apnea. The inclusion criteria were as follows: (1) gender: female or male, (2) age 35-65 years old, (3) visceral obesity, (4) lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders, (5) not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)], (6) not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination. Patients, who met all inclusion criteria, underwent subject and physical examination, an over-night Holter-ECG, polygraphy and laboratory biochemical tests (sodium, potassium, calcium, magnesium concentration and fasting glyceamia.
Enrolled patients were asked questions about general frame of mind, daytime and nighttime symptoms that may suggest OSA [according to Epworth Sleepiness Scale (https://epworthsleepinessscale.com/about-the-ess/ access date 08 May 2020)]. All patients were fully physically examined. Neck and waist circumference were measured according to STEPwise Approach to Surveillance (STEPS) by WHO (https://www.who.int/ncds/surveillance/steps/en/. [access date 23 April.2019]. Upon subject examination (snoring and choking feeling during the sleep) a corrected neck circumference was calculated.
Polygraphy was conducted using MED Recorder device by Infoscan company according to AASM guidelines (American Academy of Sleep Medicine, International classification of sleep disorders, 2016). The device registered blood saturation, heart rate, airflow, chest and abdomen movements, body position, snoring and single lead ECG. OSA was diagnosed according to AASM definition (American Academy of Sleep Medicine, Sleep-related breathing disorders in adults, 1999): in every patient with Respiratory Disturbance Index (RDI) ≥ 5/hour and with concomitant OSA sings (Epworth Sleepiness Scale ≥ 11 pts) or with RDI ≥ 15/hour. The minimum time of analyzed data without artifacts had to last at least 6 h.
A Holter-ECG examination was conducted using DMS 300-3A device by Oxford company suitable for Cardioscan 10 system. Registration was made simultaneously with polygraphy, during the night. Chosen QT interval assessment parameters were evaluated upon partially automatically analyzed fragments of ECG records. Only nighttime ECG records were analyzed due to maximum comparability (similar patient's physical activity and minimized, because of limited body movements, artifacts). Moreover, the study aimed to assess a heart's activity simultaneous to sleep breathing disorders. Only ECG strips with constant heart rate, optimally within 50-70/min limits, were chosen due to the minimum impact of such heart rate on QT interval correction formula. QTc data was calculated upon Bazett's formula. QTV and QTVi were calculated upon Berger's formula.
After getting all results they were checked against the following exclusion criteria: 1) revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics, 2) revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg, 3) revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible, 4) too short total sleep time (< 6 hours) registered on polygraphy.
Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA + | – | Diagnostic Test: Polygraphy monitoring, Diagnostic Test: laboratory testsPatients with visceral obesity and newly diagnosed Obstructive Sleep Apnea (during the study) |
| OSA - | – | Diagnostic Test: Polygraphy monitoring, Diagnostic Test: laboratory testsPatients with visceral obesity in whom Obstructive Sleep Apnea diagnosis have been excluded (during the study) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Out of 187 consecutive patients meeting the inclusion criteria, 66 patients met at least one exclusion criterion, leaving 121 patients for the study analyses.
Key inclusion criteria (6 listed)
- gender: female or male,
- age 35-65 years old,
- visceral obesity,
- lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders,
- not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)],
Key exclusion criteria (4 listed)
- revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics,
- revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg,
- revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible,
- too short total sleep time (< 6 hours) registered on polygraphy.
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 |
|---|---|---|
| Polygraphy monitoringAlso: Holter ECG monitoringAll patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring. | Diagnostic test | OSA +, OSA - |
| laboratory testsBlood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity. | Diagnostic test | OSA +, OSA - |
Primary outcome
A number of patients with visceral obesity and Obstructive Sleep Apnea
Time frame: one day per each patient
Polygraphy examination of each patient
2 secondary outcomes
A number of patients with visceral obesity and heart rhythm disorders occurrence.
Time frame: Holter ECG - one day per patient
Correlation of Obstructive Sleep Apnea and ECG changes among OSA positive and negative patients
Time frame: 2016-2019
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 27 Nov 2020.
- Background: PubMed 19720569Alam I, Lewis MJ, Lewis KE, Stephens JW, Baxter JN. Influence of bariatric surgery on indices of cardiac autonomic control. Auton Neurosci. 2009 Dec 3;151(2):168-73. doi: 10.1016/j.autneu.2009.08.007. Epub 2009 Aug 31.
- Background2. American Academy of Sleep Medicine. International classification of sleep disorders, 2nd ed. Diagnostic and coding manual. Westchester, Illinois: American Academy of Sleep Medicine 2005. Updated November 2015. Darien, IL: American Academy of Sleep medicine, 2016.
- Background: PubMed 10450601Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available.
- Background: PubMed 20567204Arslan E, Yiginer O, Yavasoglu I, Ozcelik F, Kardesoglu E, Nalbant S. Effect of uncomplicated obesity on QT interval in young men. Pol Arch Med Wewn. 2010 Jun;120(6):209-13.
- Background: PubMed 20552591Barta K, Szabo Z, Kun C, Munkacsy C, Bene O, Magyar MT, Csiba L, Lorincz I. The effect of sleep apnea on QT interval, QT dispersion, and arrhythmias. Clin Cardiol. 2010 Jun;33(6):E35-9. doi: 10.1002/clc.20619.
- Background: PubMed 21257917Baumert M, Schlaich MP, Nalivaiko E, Lambert E, Sari CI, Kaye DM, Elser MD, Sanders P, Lambert G. Relation between QT interval variability and cardiac sympathetic activity in hypertension. Am J Physiol Heart Circ Physiol. 2011 Apr;300(4):H1412-7. doi: 10.1152/ajpheart.01184.2010. Epub 2011 Jan 21.
- Background: PubMed 26823389Baumert M, Porta A, Vos MA, Malik M, Couderc JP, Laguna P, Piccirillo G, Smith GL, Tereshchenko LG, Volders PG. QT interval variability in body surface ECG: measurement, physiological basis, and clinical value: position statement and consensus guidance endorsed by the European Heart Rhythm Association jointly with the ESC Working Group on Cardiac Cellular Electrophysiology. Europace. 2016 Jun;18(6):925-44. doi: 10.1093/europace/euv405. Epub 2016 Jan 27.
- Background: PubMed 18652091Baumert M, Smith J, Catcheside P, McEvoy RD, Abbott D, Sanders P, Nalivaiko E. Variability of QT interval duration in obstructive sleep apnea: an indicator of disease severity. Sleep. 2008 Jul;31(7):959-66.
- Background: PubMed 15788497Gami AS, Howard DE, Olson EJ, Somers VK. Day-night pattern of sudden death in obstructive sleep apnea. N Engl J Med. 2005 Mar 24;352(12):1206-14. doi: 10.1056/NEJMoa041832.
- Background: PubMed 23770166Gami AS, Olson EJ, Shen WK, Wright RS, Ballman KV, Hodge DO, Herges RM, Howard DE, Somers VK. Obstructive sleep apnea and the risk of sudden cardiac death: a longitudinal study of 10,701 adults. J Am Coll Cardiol. 2013 Aug 13;62(7):610-6. doi: 10.1016/j.jacc.2013.04.080. Epub 2013 Jun 13.
- Background: PubMed 15464332Haigney MC, Zareba W, Gentlesk PJ, Goldstein RE, Illovsky M, McNitt S, Andrews ML, Moss AJ; Multicenter Automatic Defibrillator Implantation Trial II investigators. QT interval variability and spontaneous ventricular tachycardia or fibrillation in the Multicenter Automatic Defibrillator Implantation Trial (MADIT) II patients. J Am Coll Cardiol. 2004 Oct 6;44(7):1481-7. doi: 10.1016/j.jacc.2004.06.063.
- Background: PubMed 19406266Hinterseer M, Beckmann BM, Thomsen MB, Pfeufer A, Dalla Pozza R, Loeff M, Netz H, Steinbeck G, Vos MA, Kaab S. Relation of increased short-term variability of QT interval to congenital long-QT syndrome. Am J Cardiol. 2009 May 1;103(9):1244-8. doi: 10.1016/j.amjcard.2009.01.011. Epub 2009 Mar 18.
- Individual participant dataSharing planned: Yes. For a reasonable request the principal intevstigator will share stastical data of studied group.
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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.
Aleksandra Jarecka-Dobroń, PhD principal investigator
NowodworskieMD
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Heart Rhythm Disorder, run by Nowodworskie Centrum Medyczne.
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 6 inclusion and 4 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
A number of patients with visceral obesity and Obstructive Sleep Apnea (time frame: one day per each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621032, which also lists 26 linked publications.
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 27 Nov 2020.