Sleep Apnea/Hypopnea SyndromeNCT02569749
Sleep Apnea Screening
An observational study of Sleep Apnea/Hypopnea Syndrome, run by Arrhythmia Network Technology S.L. at 9 sites in Spain.
Trial summary
To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea/Hypopnea Syndrome
- What is being tested?
- Berlin and Epworth questionaries, Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted. and Night polygraph / Polysomnography
- How many people
- 15 participants
- Where
- 9 sitesSpain
- Study dates
- Jun 2015to Mar 2016
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients to be included in the registry: * 200 patients with pacemaker indication in whom a pacemaker with sleep apnea monitoring system has been implanted. * 100 patients with pacemaker indication in whom a pacemaker with no sleep apnea monitoring system has been implanted. * 100 patients with ICD or CRDT therapy indication. * 100 patients with heart failure and preserved LVEF (40-50%). * 100 patients with heart failure and reduced LVEF (<40%).
Who may be able to join
- Age 18 years or older
- No previous diagnosis of sleep apnea
- Fulfilling at least one of the following:
- Pacemaker indication
- ICD or CRTD therapy indication
- Heart failure and preserved LVEF (40-50%)
- Heart failure and reduced LVEF (<40%)
- Signed informed consent
Who cannot join
- Age younger than 18 years
- Renal hemodialysis
- Cardiac transplant indication
- Women who are pregnant
- Advanced cancer
- Enrollment in another investigational study
- Able and willing to comply with all testing and requirements
- Patient not suitable for inclusion due to psychiatric conditions or short life expectancy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Nuestra Señora de Sonsoles
Ávila
Hospital Infanta Cristina
Badajoz
Hospital Universitario de Burgos
Burgos
Hospital General Universitario de Ciudad Real
Ciudad Real
HM Hospitales
Madrid
Hospital Clínico Universitario San Carlos
Madrid
Hospital Universitario de Fuenlabrada
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Puerta de Hierro
Madrid
About this study
Official title: Sleep Apnea-Hypopnea Syndrome Screening
To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.
- Conditions
- Sleep Apnea/Hypopnea Syndrome
- Being tested
- Berlin and Epworth questionaries, Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted., Night polygraph / Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berlin and Epworth questionariesOther
Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.Other
Night polygraph / PolysomnographyOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with pacemaker indication (pacemaker already implanted or to be implanted) Receives: Other: Berlin and Epworth questionaries; Other: Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.; Other: Night polygraph / Polysomnography | |
| Group 2 | Patients with ICD or CRTD therapy indication (device already implanted or to be implanted) Receives: Other: Berlin and Epworth questionaries; Other: Night polygraph / Polysomnography | |
| Group 3 | Patients with heart failure an preserved LVEF (40-50%) Receives: Other: Berlin and Epworth questionaries; Other: Night polygraph / Polysomnography | |
| Group 4 | Patients with heart failure and reduced LVEF (<40%) Receives: Other: Berlin and Epworth questionaries; Other: Night polygraph / Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with SAHS in patients with pacemaker indication
Measured: 1 month
Percentage of patients with SAHS in patients with ICD or CRTD therapy
Measured: 1 month
Percentage of patients with SAHS in patients with heart failure and preserved LVEF
Measured: 1 month
Percentage of patients with SAHS in patients with reduced LVEF
Measured: 1 month
Secondary outcomes (2)
Percentage of patients with obstructive sleep apnea in all groups
Measured: 1 month
Percentage of patients with central sleep apnea in all groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea/Hypopnea SyndromeStudies 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
- 15 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Arrhythmia Network Technology S.L.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569749
- Sponsor's protocol ID
- SAHS2
- Status last verified
- Nov 2015
- First submitted
- 6 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
PubMed 9406321Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Marshall NS, Wong KK, Liu PY, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008 Aug;31(8):1079-85.
PubMed 18714779Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
PubMed 18714778Ronald J, Delaive K, Roos L, Manfreda J, Bahammam A, Kryger MH. Health care utilization in the 10 years prior to diagnosis in obstructive sleep apnea syndrome patients. Sleep. 1999 Mar 15;22(2):225-9. doi: 10.1093/sleep/22.2.225.
PubMed 10201067Fietze I, Rottig J, Quispe-Bravo S, Riedel F, Witte J, Baumann G, Witt C. Sleep apnea syndrome in patients with cardiac pacemaker. Respiration. 2000;67(3):268-71. doi: 10.1159/000029509.
PubMed 10867594Garrigue S, Pepin JL, Defaye P, Murgatroyd F, Poezevara Y, Clementy J, Levy P. High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study. Circulation. 2007 Apr 3;115(13):1703-9. doi: 10.1161/CIRCULATIONAHA.106.659706. Epub 2007 Mar 12.
PubMed 17353437Pepin JL, Chouri-Pontarollo N, Tamisier R, Levy P. Cheyne-Stokes respiration with central sleep apnoea in chronic heart failure: proposals for a diagnostic and therapeutic strategy. Sleep Med Rev. 2006 Feb;10(1):33-47. doi: 10.1016/j.smrv.2005.10.003. Epub 2005 Dec 22.
PubMed 16376589Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8. doi: 10.1016/j.ijcard.2004.12.068.
PubMed 16321661Tremel F, Pepin JL, Veale D, Wuyam B, Siche JP, Mallion JM, Levy P. High prevalence and persistence of sleep apnoea in patients referred for acute left ventricular failure and medically treated over 2 months. Eur Heart J. 1999 Aug;20(16):1201-9. doi: 10.1053/euhj.1999.1546.
PubMed 10448029Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
PubMed 24561163Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
PubMed 9626176Arias MA, Garcia-Rio F, Alonso-Fernandez A, Sanchez AM. [Sleep apnea-hypopnea syndromes and heart failure]. Rev Esp Cardiol. 2007 Apr;60(4):415-27. Spanish.
PubMed 17521550Kasai T, Bradley TD. Obstructive sleep apnea and heart failure: pathophysiologic and therapeutic implications. J Am Coll Cardiol. 2011 Jan 11;57(2):119-27. doi: 10.1016/j.jacc.2010.08.627.
PubMed 21211682
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea-Hypopnea Syndrome Screening
- ClinicalTrials.gov ID
- NCT02569749
- Acronym / sponsor ID
- SAHS2
- Conditions
- Sleep Apnea/Hypopnea Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arrhythmia Network Technology S.L.University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- 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.
To assess the incidence of Sleep Apnea-Hypopnea Syndrome (SAHS), both obstructive and central, in patients with: 1) pacemaker indication; 2) implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRTD), 3) heart failure and preserved left ventricular ejection fraction (LVEF) and 4) heart failure and reduced LVEF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Berlin and Epworth questionaries, Other: Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted., Other: Night polygraph / PolysomnographyPatients with pacemaker indication (pacemaker already implanted or to be implanted) |
| Group 2 | – | Other: Berlin and Epworth questionaries, Other: Night polygraph / PolysomnographyPatients with ICD or CRTD therapy indication (device already implanted or to be implanted) |
| Group 3 | – | Other: Berlin and Epworth questionaries, Other: Night polygraph / PolysomnographyPatients with heart failure an preserved LVEF (40-50%) |
| Group 4 | – | Other: Berlin and Epworth questionaries, Other: Night polygraph / PolysomnographyPatients with heart failure and reduced LVEF (<40%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be included in the registry: * 200 patients with pacemaker indication in whom a pacemaker with sleep apnea monitoring system has been implanted. * 100 patients with pacemaker indication in whom a pacemaker with no sleep apnea monitoring system has been implanted. * 100 patients with ICD or CRDT therapy indication. * 100 patients with heart failure and preserved LVEF (40-50%). * 100 patients with heart failure and reduced LVEF (<40%).
Key inclusion criteria (8 listed)
- Age 18 years or older
- No previous diagnosis of sleep apnea
- Fulfilling at least one of the following:
- Signed informed consent
Key exclusion criteria (8 listed)
- Age younger than 18 years
- Renal hemodialysis
- Cardiac transplant indication
- Women who are pregnant
- Advanced cancer
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 |
|---|---|---|
| Berlin and Epworth questionaries | Other | Group 1, Group 2, Group 3, Group 4 |
| Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted. | Other | Group 1 |
| Night polygraph / Polysomnography | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Percentage of patients with SAHS in patients with pacemaker indication
Time frame: 1 month
Percentage of patients with SAHS in patients with ICD or CRTD therapy
Time frame: 1 month
Percentage of patients with SAHS in patients with heart failure and preserved LVEF
Time frame: 1 month
Percentage of patients with SAHS in patients with reduced LVEF
Time frame: 1 month
2 secondary outcomes
Percentage of patients with obstructive sleep apnea in all groups
Time frame: 1 month
Percentage of patients with central sleep apnea in all groups
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Background: PubMed 9406321Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6. doi: 10.1093/sleep/20.9.705.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 18714779Marshall NS, Wong KK, Liu PY, Cullen SR, Knuiman MW, Grunstein RR. Sleep apnea as an independent risk factor for all-cause mortality: the Busselton Health Study. Sleep. 2008 Aug;31(8):1079-85.
- Background: PubMed 18714778Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
- Background: PubMed 10201067Ronald J, Delaive K, Roos L, Manfreda J, Bahammam A, Kryger MH. Health care utilization in the 10 years prior to diagnosis in obstructive sleep apnea syndrome patients. Sleep. 1999 Mar 15;22(2):225-9. doi: 10.1093/sleep/22.2.225.
- Background: PubMed 10867594Fietze I, Rottig J, Quispe-Bravo S, Riedel F, Witte J, Baumann G, Witt C. Sleep apnea syndrome in patients with cardiac pacemaker. Respiration. 2000;67(3):268-71. doi: 10.1159/000029509.
- Background: PubMed 17353437Garrigue S, Pepin JL, Defaye P, Murgatroyd F, Poezevara Y, Clementy J, Levy P. High prevalence of sleep apnea syndrome in patients with long-term pacing: the European Multicenter Polysomnographic Study. Circulation. 2007 Apr 3;115(13):1703-9. doi: 10.1161/CIRCULATIONAHA.106.659706. Epub 2007 Mar 12.
- Background: PubMed 16376589Pepin JL, Chouri-Pontarollo N, Tamisier R, Levy P. Cheyne-Stokes respiration with central sleep apnoea in chronic heart failure: proposals for a diagnostic and therapeutic strategy. Sleep Med Rev. 2006 Feb;10(1):33-47. doi: 10.1016/j.smrv.2005.10.003. Epub 2005 Dec 22.
- Background: PubMed 16321661Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report. Int J Cardiol. 2006 Jan 4;106(1):21-8. doi: 10.1016/j.ijcard.2004.12.068.
- Background: PubMed 10448029Tremel F, Pepin JL, Veale D, Wuyam B, Siche JP, Mallion JM, Levy P. High prevalence and persistence of sleep apnoea in patients referred for acute left ventricular failure and medically treated over 2 months. Eur Heart J. 1999 Aug;20(16):1201-9. doi: 10.1053/euhj.1999.1546.
- Background: PubMed 24561163Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19.
- Background: PubMed 9626176Javaheri S, Parker TJ, Liming JD, Corbett WS, Nishiyama H, Wexler L, Roselle GA. Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation. 1998 Jun 2;97(21):2154-9. doi: 10.1161/01.cir.97.21.2154.
Related trials for Sleep Apnea/Hypopnea Syndrome
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea/Hypopnea Syndrome, run by Arrhythmia Network Technology S.L. at 9 sites in Spain.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. 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 was stopped early (reason given: Administrative reasons). Results are not available in the source record.
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?
Percentage of patients with SAHS in patients with pacemaker indication (time frame: 1 month). The study lists 4 primary outcomes in all. 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 NCT02569749, which also lists 14 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 3 Nov 2015.