Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With CPAP (CAPCORSAS)
28. januar 2019 oppdatert av: Centre Hospitalier Universitaire de Saint Etienne
Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With a Continuous Positive Airway Pressure System (CPAP). Etude CAPCORSAS
The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic patients do not complain in their daytime functioning. The objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of CPAP treatment given to non-sleepy apneic CAD patients.
Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the Paced Auditory Serial Addition Test score (PASAT score).
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
9
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Saint-etienne, Frankrike, 42000
- CHU de Saint-Etienne
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patient admitted to the Clinical Physiology Department of Exercise of the Saint Etienne University Hospital (myocardial infarction, coronary stenting or coronary artery bypass) and referred for care in cardiac rehabilitation
- A native French speaker
- No daytime sleepiness (ESS <or = 10)
- Signature of informed consent by the patient
Exclusion Criteria:
- Patients with a previous diagnosis of sleep apnea syndrome
- Patients with severe heart failure (stage III and IV of the NYHA)
- Patients with a neurodegenerative disease or other known cognitive disorders
- Presence of progressive disease other than coronary artery disease (cancer for example)
- Patients participating in other research that can change their cognitive function or drowsiness
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Patients treated
Patients with CAD and SAS.
This patients should have an apnea-hypopnea index (AHI) between 15 and 40, and an Epworth sleepiness score (ESS) <10.
After randomization, they will be treated with CPAP treatment.
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Patients treated wear a face mask during sleep which is connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airway and stimulate normal breathing.
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Ingen inngripen: Patients non-treated
Patients with CAD and SAS.
This patients should have an apnea-hypopnea index (AHI) between 15 and 40, and an ESS <10.
After randomization, they will be not treated.
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Ingen inngripen: Control group
Patients with CAD but without SAS (AHI<15).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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PASAT-4sec test score
Tidsramme: Day 120
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The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability.
Single digits are presented every 4 seconds and the patient must add each new digit to the one immediately prior to it.
The score for the PASAT is the total number correct out of 60 possible answers.
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Day 120
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Score Mini Mental State (MMS)
Tidsramme: Day 120
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It is a score obtained in psychometric tests.
This is a series of 30 questions that assesses cognitive and mnemonic ability of a person.
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Day 120
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Mean time (ms) obtained in a Continus Performance Test
Tidsramme: Day 120
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It is an other score obtained in psychometric tests.
It measures a person's sustained and selective attention (associated with impulsivity and distractibility).
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Day 120
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Percentage (%) obtained in a test measurement of the reaction time
Tidsramme: Day 120
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It is an other score obtained in psychometric tests.
It is a psychometer vigilance test.
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Day 120
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Mean time (ms) obtained in a test measurement of the reaction time
Tidsramme: Day 120
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It is an other score obtained in psychometric tests.
It is a psychometer vigilance test.
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Day 120
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Percentage (%) for a N-back working memory task
Tidsramme: Day 120
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It is an other score obtained in psychometric tests.
The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence.
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Day 120
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Average time (ms) for a N-back working memory task
Tidsramme: Day 120
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It is an other score obtained in psychometric tests.
The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence.
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Day 120
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AHI
Tidsramme: Day 120
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It is the number of apnea and hypopnea per hour.
It determined by polysomnography.
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Day 120
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Mean nocturnal oxygen saturation (%)
Tidsramme: Day 120
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It is a percentage index of hypoxemia measured by a polysomnography.
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Day 120
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Minimal nocturnal oxygen saturation (%)
Tidsramme: Day 120
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It is an other percentage index of hypoxemia measured by a polysomnography.
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Day 120
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The oxyhemoglobin desaturation index
Tidsramme: Day 120
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It is an other index of hypoxemia measured by a polysomnography.
It is expressed in desaturations / hour
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Day 120
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The time (min) spent with a SaO2 below 90%
Tidsramme: Day 120
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The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.
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Day 120
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Sleep fragmentation
Tidsramme: Day 120
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It is determined by a polysomnography.
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Day 120
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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2014
Primær fullføring (Faktiske)
24. februar 2016
Studiet fullført (Faktiske)
29. februar 2016
Datoer for studieregistrering
Først innsendt
24. august 2015
Først innsendt som oppfylte QC-kriteriene
24. august 2015
Først lagt ut (Anslag)
26. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. januar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. januar 2019
Sist bekreftet
1. januar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Arteriosklerose
- Arterielle okklusive sykdommer
- Respirasjonsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvåkenforstyrrelser
- Sykdom
- Tegn og symptomer, luftveier
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Søvnapné syndromer
- Søvnapné, obstruktiv
- Syndrom
- Apné
- Akutt koronarsyndrom
Andre studie-ID-numre
- 1308171
- 2013-A01635-40 (Annen identifikator: ANSM)
Plan for individuelle deltakerdata (IPD)
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NEI
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