Acute Myocardial InfarctionAMISLEEPNCT04064593
Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors
A study testing Polygraphy in people with Acute Myocardial Infarction and Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The AMISLEEP study is nested in the "FRENCHIE" registry. The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Sleep Apnea
- What is being tested?
- Polygraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,007 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2019to 3 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient included in FRENCHIE registry (cf. NCT04050956 for FRENCHIE registry's selection criteria)
- Signed consent for AMI-Sleep study
Who cannot join
- Patient under treatment for SDB/SAS prior to its inclusion in FRENCHIE registry
- Cognitive disorientation and communicative disabilities (left to investigator's discretion) not able to fill-out a questionnaire
- Severe diseases with anticipated mortality less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SDB Prevalence and Cardiovascular Outcomes of MI Survivors
The AMISLEEP study is nested in the "FRENCHIE" registry.
The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes.
Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.
Read the detailed description
All patients included in the "FRENCHIE" registry (Acute Myocardial Infarction (AMI) patients hospitalized within 48h from symptom onset) are eligible, and will be asked for their written informed consent for this nested study in case of the absence of any non-inclusion criteria.
Baseline clinical examination and laboratory tests are based on the usual care and are those collected in "FRENCHIE".
A simplified polygraphy is performed during the hospitalization for AMI. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours.
Together with the polygraphy, questionnaires will be given to the patient regarding general sleep quality
Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management to centers.
Follow-up will be performed through the national administrative databases, as in the "FRENCHIE" registry.
- Conditions
- Acute Myocardial Infarction, Sleep Apnea
- Being tested
- Polygraphy
- Keywords
- Acute Myocardial Infarction, Sleep Apnea, Outcomes
- 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.
PolygraphyDiagnostic test
The polygraphy consists of recording during sleep, respiratory flow by mean of a nasal cannula, respiratory movement by mean of a thoracic belt with inductance plethysmography, blood oxygenation and heartbeats by a fingertip transcutaneous oxymetry.
Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours.
Polygraphy data are anonymized before being sent to the Cloud and therefore to the core lab.
Polygraphic data will be scored in centralized manner.
Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up.
If necessary, the core-lab will provide tele-counseling regarding SDB management.
| Study group | Role | What they receive |
|---|---|---|
| Polygraphy | Experimental | Not described Receives: Diagnostic Test: Polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contribution of SDB/SAS to events after AMI
Contribution of SDB/SAS to incident cardiovascular events and mortality during the first year following acute myocardial infraction :
Cardiovascular event will be defined as incident acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke or death of any cause after discharge during the first year following the AMI event. Time from discharge to the first event will be considered.
Measured: 12 months follow up
Secondary outcomes (4)
Associations between presence, type and severity of SDB and the severity of the initial coronary disease
The severity of the index event (number of stents combined with revascularizations and coronary bypass) will be compared to type and severity of SDB (apnea-hypopnea index AHI), to evaluate if both are associated
Measured: Through the end of hospitalization, an average of 5 days
Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients
Concordance between the result of the Berlin questionnaire and the presence of obstructive SDB/SAS measured by polygraphy as reference and concordance between the result of the Berlin questionnaire and the presence of central SDB/SAS measured by polygraphy as reference.
Measured: Through the end of hospitalization, an average of 5 days
Evaluate health care related costs during the year following hospital discharge.
Health care related costs for SDB considered will be: confirmation of SDB by an additional polysomnography, SDB treatments.
Measured: 12 months follow up
Comparison of health care consumption between SDB and non-SDB patients
Health care consumption and health care related costs will be compared between patients :
- without SDB
- with mild SDB (AHI between 5 and 14/h)
- with moderate SDB (AHI between 15h to 29/h)
- with severe SDB (AHI ≥ 30/h)
Health care consumption and health care related costs considered will be AMI recurrence, incident TIA/stroke, cardiac arrhythmia, heart decompensation, diabetes, depression and cancers.
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start9 Apr 2019
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 2,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Philippe Gabriel STEG, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064593
- Sponsor's protocol ID
- P171101J
- Acronym
- AMISLEEP
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2019
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Young 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 8464434Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
PubMed 11254524Crawford-Achour E, Dauphinot V, Martin MS, Tardy M, Gonthier R, Barthelemy JC, Roche F. Protective Effect of Long-Term CPAP Therapy on Cognitive Performance in Elderly Patients with Severe OSA: The PROOF Study. J Clin Sleep Med. 2015 Apr 15;11(5):519-24. doi: 10.5664/jcsm.4694.
PubMed 25700873Cadelis G, Fayad Y Monteagudo OE. [Prevalence of symptoms and risk of obstructive sleep apnea syndrome assessed by the Berlin Questionnaire among professionals of a health facility]. Rev Epidemiol Sante Publique. 2016 Dec;64(6):405-414. doi: 10.1016/j.respe.2016.06.332. Epub 2016 Oct 31. French.
PubMed 27810127Tishler PV, Larkin EK, Schluchter MD, Redline S. Incidence of sleep-disordered breathing in an urban adult population: the relative importance of risk factors in the development of sleep-disordered breathing. JAMA. 2003 May 7;289(17):2230-7. doi: 10.1001/jama.289.17.2230.
PubMed 12734134Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.
PubMed 25682233Levendowski D, Steward D, Woodson BT, Olmstead R, Popovic D, Westbrook P. The impact of obstructive sleep apnea variability measured in-lab versus in-home on sample size calculations. Int Arch Med. 2009 Jan 2;2(1):2. doi: 10.1186/1755-7682-2-2.
PubMed 19121211Jesus EV, Dias-Filho EB, Mota Bde M, Souza Ld, Marques-Santos C, Rocha JB, Oliveira JL, Sousa AC, Barreto-Filho JA. Suspicion of obstructive sleep apnea by Berlin Questionnaire predicts events in patients with acute coronary syndrome. Arq Bras Cardiol. 2010 Sep;95(3):313-20. doi: 10.1590/s0066-782x2010005000103. Epub 2010 Aug 6.
PubMed 20676583Gus M, Goncalves SC, Martinez D, de Abreu Silva EO, Moreira LB, Fuchs SC, Fuchs FD. Risk for Obstructive Sleep Apnea by Berlin Questionnaire, but not daytime sleepiness, is associated with resistant hypertension: a case-control study. Am J Hypertens. 2008 Jul;21(7):832-5. doi: 10.1038/ajh.2008.184. Epub 2008 May 1.
PubMed 18451807Balagny P, D'Ortho MP, Berard L, Rousseau A, Gourmelen J, Ravaud P, Durand-Zaleski I, Simon T, Steg PG; AMI SLEEP investigators. AMI-Sleep: protocol for a prospective study of sleep-disordered breathing/sleep apnoea syndrome and incident cardiovascular events after acute myocardial infarction. BMJ Open. 2025 Feb 18;15(2):e090093. doi: 10.1136/bmjopen-2024-090093.
PubMed 39965954
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SDB Prevalence and Cardiovascular Outcomes of MI Survivors
- ClinicalTrials.gov ID
- NCT04064593
- Acronym / sponsor ID
- AMISLEEP / P171101J
- Conditions
- Acute Myocardial Infarction, Sleep Apnea
- Keywords
- Acute Myocardial Infarction, Sleep Apnea, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 22 Aug 2019 (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.
The AMISLEEP study is nested in the "FRENCHIE" registry.
The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes.
Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.
Detailed description
All patients included in the "FRENCHIE" registry (Acute Myocardial Infarction (AMI) patients hospitalized within 48h from symptom onset) are eligible, and will be asked for their written informed consent for this nested study in case of the absence of any non-inclusion criteria.
Baseline clinical examination and laboratory tests are based on the usual care and are those collected in "FRENCHIE".
A simplified polygraphy is performed during the hospitalization for AMI. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours.
Together with the polygraphy, questionnaires will be given to the patient regarding general sleep quality
Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management to centers.
Follow-up will be performed through the national administrative databases, as in the "FRENCHIE" registry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polygraphy | Experimental | Diagnostic Test: Polygraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient included in FRENCHIE registry (cf. NCT04050956 for FRENCHIE registry's selection criteria)
- Signed consent for AMI-Sleep study
Key exclusion criteria (3 listed)
- Patient under treatment for SDB/SAS prior to its inclusion in FRENCHIE registry
- Cognitive disorientation and communicative disabilities (left to investigator's discretion) not able to fill-out a questionnaire
- Severe diseases with anticipated mortality less than 6 months
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 |
|---|---|---|
| PolygraphyThe polygraphy consists of recording during sleep, respiratory flow by mean of a nasal cannula, respiratory movement by mean of a thoracic belt with inductance plethysmography, blood oxygenation and heartbeats by a fingertip transcutaneous oxymetry. Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours. Polygraphy data are anonymized before being sent to the Cloud and therefore to the core lab. Polygraphic data will be scored in centralized manner. Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up. If necessary, the core-lab will provide tele-counseling regarding SDB management. | Diagnostic test | Polygraphy |
Primary outcome
Contribution of SDB/SAS to events after AMI
Time frame: 12 months follow up
Contribution of SDB/SAS to incident cardiovascular events and mortality during the first year following acute myocardial infraction : Cardiovascular event will be defined as incident acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke or death of any cause after discharge during the first year following the AMI event. Time from discharge to the first event will be considered.
4 secondary outcomes
Associations between presence, type and severity of SDB and the severity of the initial coronary disease
Time frame: Through the end of hospitalization, an average of 5 days
Validate the Berlin questionnaire to screen for obstructive and central SDB/SAS in the AMI patients
Time frame: Through the end of hospitalization, an average of 5 days
Evaluate health care related costs during the year following hospital discharge.
Time frame: 12 months follow up
Comparison of health care consumption between SDB and non-SDB patients
Time frame: 12 months follow up
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 20 Aug 2026.
- 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 11254524Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.
- Background: PubMed 25700873Crawford-Achour E, Dauphinot V, Martin MS, Tardy M, Gonthier R, Barthelemy JC, Roche F. Protective Effect of Long-Term CPAP Therapy on Cognitive Performance in Elderly Patients with Severe OSA: The PROOF Study. J Clin Sleep Med. 2015 Apr 15;11(5):519-24. doi: 10.5664/jcsm.4694.
- Background: PubMed 27810127Cadelis G, Fayad Y Monteagudo OE. [Prevalence of symptoms and risk of obstructive sleep apnea syndrome assessed by the Berlin Questionnaire among professionals of a health facility]. Rev Epidemiol Sante Publique. 2016 Dec;64(6):405-414. doi: 10.1016/j.respe.2016.06.332. Epub 2016 Oct 31. French.
- Background: PubMed 12734134Tishler PV, Larkin EK, Schluchter MD, Redline S. Incidence of sleep-disordered breathing in an urban adult population: the relative importance of risk factors in the development of sleep-disordered breathing. JAMA. 2003 May 7;289(17):2230-7. doi: 10.1001/jama.289.17.2230.
- Background: PubMed 25682233Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.
- Background: PubMed 19121211Levendowski D, Steward D, Woodson BT, Olmstead R, Popovic D, Westbrook P. The impact of obstructive sleep apnea variability measured in-lab versus in-home on sample size calculations. Int Arch Med. 2009 Jan 2;2(1):2. doi: 10.1186/1755-7682-2-2.
- Background: PubMed 20676583Jesus EV, Dias-Filho EB, Mota Bde M, Souza Ld, Marques-Santos C, Rocha JB, Oliveira JL, Sousa AC, Barreto-Filho JA. Suspicion of obstructive sleep apnea by Berlin Questionnaire predicts events in patients with acute coronary syndrome. Arq Bras Cardiol. 2010 Sep;95(3):313-20. doi: 10.1590/s0066-782x2010005000103. Epub 2010 Aug 6.
- Background: PubMed 18451807Gus M, Goncalves SC, Martinez D, de Abreu Silva EO, Moreira LB, Fuchs SC, Fuchs FD. Risk for Obstructive Sleep Apnea by Berlin Questionnaire, but not daytime sleepiness, is associated with resistant hypertension: a case-control study. Am J Hypertens. 2008 Jul;21(7):832-5. doi: 10.1038/ajh.2008.184. Epub 2008 May 1.
- Derived from this study: PubMed 39965954Balagny P, D'Ortho MP, Berard L, Rousseau A, Gourmelen J, Ravaud P, Durand-Zaleski I, Simon T, Steg PG; AMI SLEEP investigators. AMI-Sleep: protocol for a prospective study of sleep-disordered breathing/sleep apnoea syndrome and incident cardiovascular events after acute myocardial infarction. BMJ Open. 2025 Feb 18;15(2):e090093. doi: 10.1136/bmjopen-2024-090093.
- Individual participant dataSharing planned: Undecided
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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.
Philippe Gabriel STEG principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygraphy in people with Acute Myocardial Infarction and Sleep Apnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 2 inclusion and 3 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 20 Aug 2026. 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 France. 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?
Contribution of SDB/SAS to events after AMI (time frame: 12 months follow up). 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 NCT04064593, which also lists 10 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 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.