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Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure (CardioX SAS)

26 oktober 2021 uppdaterad av: University Hospital, Montpellier

Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.

Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population.

The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Obstructive sleep apnea syndrome (OSAS) is a common disorder characterized by recurrent upper airway collapse during sleep and has been associated with worsened prognosis in patients with coronary artery disease (CAD). Moderate OSAS can be defined by an apnea hypopnea index (AHI) between 15 and 30 events/hour.

Pathophysiologic processes are complex and it seems that oxidative stress play and important role. Studies showed that continuous positive airway pressure (CPAP) influence oxidative stress but the results are conflicting.

Moreover there are uncertainties whether diagnosing and treating OSAS can influence the pathophysiological and clinical outcomes in patients with CAD.

Therefore, we aim to test the effects of 3 months of CPAP on systemic redox balance evaluated by plasma GSH/GSSG ratio.

Patients with moderate OSAS will be randomized for the intervention.

Patients with AHI <15/h or >30/h will be included in an ancillary study (blood and urinary test, MIBG scintigraphy) to characterize the biological profile of coronary patients based on their AHI.

For a alpha threshold of 5% and a study power of 80%, the study should include 16 patients in each group. Taking in account a possible 20% of dropout the study will need to include 20 patients by randomized arm to demonstrate an effect.

Studietyp

Interventionell

Inskrivning (Faktisk)

28

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Montpellier, Frankrike, 34295
        • CHU of MONTPELLIER

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Apnea Hypopnea Index 15-30/h
  • Stable Coronary artery disease
  • Obligation of obtaining informed consent form

Exclusion Criteria:

  • Heart failure with LVEF less than or equal to 45%
  • Other Chronic disease: renal failure, COPD Index - central apneas than or equal to 50% of the total IAH
  • treatment with CPAP or mandibular advancement device
  • IMC> 40 kg / m²
  • Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins ...).
  • Treatment with allopurinol or N-acetylcysteine, in the 4 weeks preceding the study.
  • PaCO2> 45 mmHg - Counter-indication to the use of PPC: bullous lung disease, pathological hypotension, bypass airway, pneumothorax, signs of sinus infections or inner ear
  • Exclusion period on subject compared to another protocol or for which the maximum annual amount of compensation of € 4,500 has been reached.
  • Participation of the subject to another study.
  • Not affiliated with a social security scheme subject or not the beneficiary of such a regime.
  • Pregnant or breastfeeding women, patient unable to give consent, protected adult, vulnerable
  • Subject deprived of liberty by judicial or administrative decision
  • HIV infection, hepatitis B or hepatitis C known

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Experimental
Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months
Enhet: Continuous positive airway pressure
Continuous positive airway pressure treatment during three months with adherence recording
Sham Comparator: Sham Comparator
Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months
Enhet: Sham-kontinuerligt positivt luftvägstryck
Sham-kontinuerligt positivt luftvägstryck under tre månader med vidhäftningsregistrering

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage change of serum GSH/GSSG ratio
Tidsram: at the inclusion and the end (3 months) of the study
Blood test
at the inclusion and the end (3 months) of the study

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the catalase (parameters of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
by blood test
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the GPX (parameter of serum oxidative stress level)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the inflammation parameters: IL6, IL8, TNF α (blood test)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the urinary catecholamines by urine test
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the MIBG scintigraphy
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the endothelial function (endoPat)
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the blood pressure
Tidsram: at the inclusion and the end (3 months) of the study
24h ambulatory blood pressure monitoring
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the quality of life by the SF 36 questionnaire
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the quality of sleep by PSQI questionnaire
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the sleepiness by the Epworth scale
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study
Change, after 3 months, of the physical activity by the Voorips questionnaire
Tidsram: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Montpellier

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2016

Primärt slutförande (Faktisk)

1 juli 2021

Avslutad studie (Faktisk)

29 juli 2021

Studieregistreringsdatum

Först inskickad

4 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

2 september 2016

Första postat (Uppskatta)

9 september 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 oktober 2021

Senast verifierad

1 oktober 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UF 9542

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