Central ApnoeasNCT01723189
Pathophysiology of Central Apnoeas in Stroke Patients
An observational study of Central Apnoeas and Stroke Patients, run by MPons at 1 site in Switzerland.
Trial summary
40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Apnoeas, Stroke Patients
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2012to Aug 2014
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients
- ≥35 years old and < 75 years old
- with clinical diagnosis of TIA or ischemic stroke
- admitted in a Stroke Unit within 2 days from onset of symptoms
- signed Informed Consent
Who cannot join
- Patients
- with unstable clinical situation (cardio-respiratory or life-threatening medical conditions)
- currently on continuous positive airway pressure (CPAP) or on CPAP during the last 3 months before stroke
- with non-ischemic events (intracerebral/subarachnoid haemorrhage)
- Patients with coma/stupor
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ospedale Civico
Lugano, Canton Ticino, 6903
Marco Pons, MD, +41 91 811 6449, marco.pons@eoc.ch
Alessia Riglietti, MD, +41 91 811 6317, alessia.riglietti@eoc.ch
About this study
Official title: Central Apnoeas in the Course of Transient Ischemic Attack/Ischemic Stroke: Clinical, Prognostic, Pathophysiological Elements.
40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.
Clinical studies conducted in patients with hearth failure and central apnoeas have demonstrated the pathogenetic central role of hypersensitivity of central and peripheral chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity of sympathetic nervous system.
Read more
The joint study of chemoreflexes and baroreflexes in patients with central apneas during the acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in literature, that should supply useful elements to clarify the pathogenesis and the clinical and prognostic significance of these disorders.
Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than patients with ischemic stroke not accompanied by respiratory problems and compared with healthy controls.
Read the detailed description
Investigators expected to include in the study of 120 patients, aged between 35 and 75 years, belonging to the following diagnostic categories:
- 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
- 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
- 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
- 30 healthy controls matched for age, sex, race and BMI.
For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the cardiac rate (RR interval) and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.
For the study of central chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of Oxygen partial pressure (PaO2). The ventilatory response to hypercapnia is calculated by the method of linear regression and is represented by the angular coefficient of the straight line that describes the variation of ventilation for each variation of alveolar carbon dioxide partial pressure (PCO2).
For the study of peripheral chemoreceptors will be used the single-breath or transient hypercapnia test. The patient makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. It is expected, therefore, a period of 3 seconds, required because the gases contained in the mixture may come from the pulmonary circulation to the peripheral circulation, at the level of peripheral chemoreceptors. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.
- Conditions
- Central Apnoeas, Stroke Patients
- Keywords
- central apnoeas, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Central Apnoeas Patients | • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas) | |
| Obstructive apnoea patients | • 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h) | |
| No SDB patients | * • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography | |
| Healthy controls | • 30 healthy controls matched for age, sex, race and BMI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baroreflexes
For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the RR interval and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.
Measured: 3 months
Chemoreflexes
For the study of central and peripheral chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of PaO2, and the single-breath test in wich the subject makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.
Measured: 3 months
Secondary outcomes (1)
Apnoea-hypopnoea index (AHI)
Assessing prognosis and spontaneous temporal evolution of central apnoeas in patients with cerebral ischemic events.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Central ApnoeasStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MPons
- Sponsor type
- Other government
- Collaborators
- Advisory Board of scientific Reserch Ente Ospedaliero Cantonale, ABREOC, University of Geneva, Switzerland, University of Milan
- Responsible party
- Sponsor-investigator, MPons, Ospedale Civico, Lugano
- Investigators
- Marco Pons, MD, Principal investigator, Ospedale Regionale di Lugano - Civico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723189
- Sponsor's protocol ID
- EOC.NSI.12.04
- Status last verified
- Nov 2012
- First submitted
- 19 Oct 2012
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bassetti CL. Sleep and stroke. Semin Neurol. 2005 Mar;25(1):19-32. doi: 10.1055/s-2005-867073.
PubMed 15798934Giannoni A, Emdin M, Poletti R, Bramanti F, Prontera C, Piepoli M, Passino C. Clinical significance of chemosensitivity in chronic heart failure: influence on neurohormonal derangement, Cheyne-Stokes respiration and arrhythmias. Clin Sci (Lond). 2008 Apr;114(7):489-97. doi: 10.1042/CS20070292.
PubMed 17961123Nopmaneejumruslers C, Kaneko Y, Hajek V, Zivanovic V, Bradley TD. Cheyne-Stokes respiration in stroke: relationship to hypocapnia and occult cardiac dysfunction. Am J Respir Crit Care Med. 2005 May 1;171(9):1048-52. doi: 10.1164/rccm.200411-1591OC. Epub 2005 Jan 21.
PubMed 15665317Siccoli MM, Valko PO, Hermann DM, Bassetti CL. Central periodic breathing during sleep in 74 patients with acute ischemic stroke - neurogenic and cardiogenic factors. J Neurol. 2008 Nov;255(11):1687-92. doi: 10.1007/s00415-008-0981-9. Epub 2008 Nov 13.
PubMed 19009334Robinson TG, James M, Youde J, Panerai R, Potter J. Cardiac baroreceptor sensitivity is impaired after acute stroke. Stroke. 1997 Sep;28(9):1671-6. doi: 10.1161/01.str.28.9.1671.
PubMed 9303008Eames PJ, Blake MJ, Dawson SL, Panerai RB, Potter JF. Dynamic cerebral autoregulation and beat to beat blood pressure control are impaired in acute ischaemic stroke. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):467-72. doi: 10.1136/jnnp.72.4.467.
PubMed 11909905Sykora M, Diedler J, Turcani P, Hacke W, Steiner T. Baroreflex: a new therapeutic target in human stroke? Stroke. 2009 Dec;40(12):e678-82. doi: 10.1161/STROKEAHA.109.565838. Epub 2009 Oct 15.
PubMed 19834010Yumino D, Bradley TD. Central sleep apnea and Cheyne-Stokes respiration. Proc Am Thorac Soc. 2008 Feb 15;5(2):226-36. doi: 10.1513/pats.200708-129MG.
PubMed 18250216
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Apnoeas in the Course of Transient Ischemic Attack/Ischemic Stroke: Clinical, Prognostic, Pathophysiological Elements.
- ClinicalTrials.gov ID
- NCT01723189
- Acronym / sponsor ID
- EOC.NSI.12.04
- Conditions
- Central Apnoeas, Stroke Patients
- Keywords
- central apnoeas, stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MPonsOther government
- Collaborators
- Advisory Board of scientific Reserch Ente Ospedaliero Cantonale, ABREOC, University of Geneva, Switzerland, University of Milan
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Nov 2012 (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.
40% of patients with Sleep Disorder Breathing (SDB) appearing during the acute phase of stroke show a respiratory pattern characterized by central apnoeas and/or periodic breathing.
Clinical studies conducted in patients with hearth failure and central apnoeas have demonstrated the pathogenetic central role of hypersensitivity of central and peripheral chemoreceptors in association with baroreflex hypersensitivity, expression of hyperactivity of sympathetic nervous system.
The joint study of chemoreflexes and baroreflexes in patients with central apneas during the acute and subacute phase of ischemic stroke represents, to our knowledge, a novelty in literature, that should supply useful elements to clarify the pathogenesis and the clinical and prognostic significance of these disorders.
Investigators expect a difference in the analysis of the baroreflexes and chemoreflexes in patients with ischemic stroke/transient ischemic attack (TIA) and central apnoeas than patients with ischemic stroke not accompanied by respiratory problems and compared with healthy controls.
Detailed description
Investigators expected to include in the study of 120 patients, aged between 35 and 75 years, belonging to the following diagnostic categories:
- 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas)
- 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h)
- 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography
- 30 healthy controls matched for age, sex, race and BMI.
For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the cardiac rate (RR interval) and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.
For the study of central chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of Oxygen partial pressure (PaO2). The ventilatory response to hypercapnia is calculated by the method of linear regression and is represented by the angular coefficient of the straight line that describes the variation of ventilation for each variation of alveolar carbon dioxide partial pressure (PCO2).
For the study of peripheral chemoreceptors will be used the single-breath or transient hypercapnia test. The patient makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. It is expected, therefore, a period of 3 seconds, required because the gases contained in the mixture may come from the pulmonary circulation to the peripheral circulation, at the level of peripheral chemoreceptors. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Central Apnoeas Patients | – | –• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of central apnoea (central apnoea index> 10 / h, or Cheyne-Stokes breathing for more than 30% of total sleep time or mixed apneas with central apnoeas> 50% of total apneas) |
| Obstructive apnoea patients | – | –• 30 patients diagnosed with TIA / ischemic stroke within 7 days of admission and evidence at polysomnography of obstructive sleep apnea (apnea-hypopnea index> 20 / h) |
| No SDB patients | – | –* • 30 patients diagnosed with TIA / stroke within 7 days of admission and no evidence of sleep respiratory disorders at polysomnography |
| Healthy controls | – | –• 30 healthy controls matched for age, sex, race and BMI. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- Patients
Key exclusion criteria (5 listed)
- Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baroreflexes
Time frame: 3 months
For the study of the baroreflexes, patients will be subjected to continuous monitoring of ECG, beat-to-beat blood pressure measured at the finger by Portapress system, respiratory rate and ventilation by pneumotachograph. The tests will be performed in the supine position and then repeated in a sitting position. Data from such monitoring will be used for analysis of the harmonic components of the RR interval and the variability of blood pressure and respiratory rate, through the method of auto regressive analysis.
Chemoreflexes
Time frame: 3 months
For the study of central and peripheral chemoreceptors, investigator will use the steady-state hypercapnic test, which measures the ventilatory response to hypercapnia at a constant level of PaO2, and the single-breath test in wich the subject makes a single deep breath of a gas mixture containing 85% O2 and 15% CO2 and then resume normal breathing. The ventilation is recorded within the next 20-30 seconds, because in this time interval is evaluated only the sensitivity of the peripheral chemoreceptors, being the latency of response of the central chemoreceptors greater than 1 minute.
1 secondary outcome
Apnoea-hypopnoea index (AHI)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- Background: PubMed 15798934Bassetti CL. Sleep and stroke. Semin Neurol. 2005 Mar;25(1):19-32. doi: 10.1055/s-2005-867073.
- Background: PubMed 17961123Giannoni A, Emdin M, Poletti R, Bramanti F, Prontera C, Piepoli M, Passino C. Clinical significance of chemosensitivity in chronic heart failure: influence on neurohormonal derangement, Cheyne-Stokes respiration and arrhythmias. Clin Sci (Lond). 2008 Apr;114(7):489-97. doi: 10.1042/CS20070292.
- Background: PubMed 15665317Nopmaneejumruslers C, Kaneko Y, Hajek V, Zivanovic V, Bradley TD. Cheyne-Stokes respiration in stroke: relationship to hypocapnia and occult cardiac dysfunction. Am J Respir Crit Care Med. 2005 May 1;171(9):1048-52. doi: 10.1164/rccm.200411-1591OC. Epub 2005 Jan 21.
- Background: PubMed 19009334Siccoli MM, Valko PO, Hermann DM, Bassetti CL. Central periodic breathing during sleep in 74 patients with acute ischemic stroke - neurogenic and cardiogenic factors. J Neurol. 2008 Nov;255(11):1687-92. doi: 10.1007/s00415-008-0981-9. Epub 2008 Nov 13.
- Background: PubMed 9303008Robinson TG, James M, Youde J, Panerai R, Potter J. Cardiac baroreceptor sensitivity is impaired after acute stroke. Stroke. 1997 Sep;28(9):1671-6. doi: 10.1161/01.str.28.9.1671.
- Background: PubMed 11909905Eames PJ, Blake MJ, Dawson SL, Panerai RB, Potter JF. Dynamic cerebral autoregulation and beat to beat blood pressure control are impaired in acute ischaemic stroke. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):467-72. doi: 10.1136/jnnp.72.4.467.
- Background: PubMed 19834010Sykora M, Diedler J, Turcani P, Hacke W, Steiner T. Baroreflex: a new therapeutic target in human stroke? Stroke. 2009 Dec;40(12):e678-82. doi: 10.1161/STROKEAHA.109.565838. Epub 2009 Oct 15.
- Background: PubMed 18250216Yumino D, Bradley TD. Central sleep apnea and Cheyne-Stokes respiration. Proc Am Thorac Soc. 2008 Feb 15;5(2):226-36. doi: 10.1513/pats.200708-129MG.
- Homepage of study centerLink provided by the sponsor.
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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.
Marco Pons, MD principal investigator
Ospedale Regionale di Lugano - Civico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Apnoeas and Stroke Patients, run by MPons at 1 site in Switzerland.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Pons, Professor (0041-91-8116449, marco.pons@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baroreflexes (time frame: 3 months). The study lists 2 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 NCT01723189, which also lists 8 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 7 Nov 2012.