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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 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

28

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

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 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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-komparator: Sham Comparator
Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months
Enhet: Sham-kontinuerlig positivt luftveistrykk
Sham-kontinuerlig positivt luftveistrykk i løpet av tre måneder med etterlevelsesregistrering

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage change of serum GSH/GSSG ratio
Tidsramme: at the inclusion and the end (3 months) of the study
Blood test
at the inclusion and the end (3 months) of the study

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change, after 3 months, of the SOD (parameter of serum oxidative stress level)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: at the inclusion and the end (3 months) of the study
at the inclusion and the end (3 months) of the study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Montpellier

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. mai 2016

Primær fullføring (Faktiske)

1. juli 2021

Studiet fullført (Faktiske)

29. juli 2021

Datoer for studieregistrering

Først innsendt

4. august 2016

Først innsendt som oppfylte QC-kriteriene

2. september 2016

Først lagt ut (Anslag)

9. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UF 9542

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