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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 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Saint-etienne, Frankrig, 42000
        • CHU de Saint-Etienne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: CPAP treatment
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.
Ingen indgriben: 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.
Ingen indgriben: Control group
Patients with CAD but without SAS (AHI<15).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PASAT-4sec test score
Tidsramme: Day 120
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.
Day 120

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score Mini Mental State (MMS)
Tidsramme: Day 120
It is a score obtained in psychometric tests. This is a series of 30 questions that assesses cognitive and mnemonic ability of a person.
Day 120
Mean time (ms) obtained in a Continus Performance Test
Tidsramme: Day 120
It is an other score obtained in psychometric tests. It measures a person's sustained and selective attention (associated with impulsivity and distractibility).
Day 120
Percentage (%) obtained in a test measurement of the reaction time
Tidsramme: Day 120
It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
Day 120
Mean time (ms) obtained in a test measurement of the reaction time
Tidsramme: Day 120
It is an other score obtained in psychometric tests. It is a psychometer vigilance test.
Day 120
Percentage (%) for a N-back working memory task
Tidsramme: Day 120
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.
Day 120
Average time (ms) for a N-back working memory task
Tidsramme: Day 120
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.
Day 120
AHI
Tidsramme: Day 120
It is the number of apnea and hypopnea per hour. It determined by polysomnography.
Day 120
Mean nocturnal oxygen saturation (%)
Tidsramme: Day 120
It is a percentage index of hypoxemia measured by a polysomnography.
Day 120
Minimal nocturnal oxygen saturation (%)
Tidsramme: Day 120
It is an other percentage index of hypoxemia measured by a polysomnography.
Day 120
The oxyhemoglobin desaturation index
Tidsramme: Day 120
It is an other index of hypoxemia measured by a polysomnography. It is expressed in desaturations / hour
Day 120
The time (min) spent with a SaO2 below 90%
Tidsramme: Day 120
The arterial oxygen saturation (SaO2)is an other index of hypoxemia measured by a polysomnography.
Day 120
Sleep fragmentation
Tidsramme: Day 120
It is determined by a polysomnography.
Day 120

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2014

Primær færdiggørelse (Faktiske)

24. februar 2016

Studieafslutning (Faktiske)

29. februar 2016

Datoer for studieregistrering

Først indsendt

24. august 2015

Først indsendt, der opfyldte QC-kriterier

24. august 2015

Først opslået (Skøn)

26. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1308171
  • 2013-A01635-40 (Anden identifikator: ANSM)

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