- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02127177
Long-term Effects of CPAP on Lipidemia and Hs-CRP Levels in OSA Patients
28. april 2014 oppdatert av: Chinese Pulmonary Vascular Disease Research Group
Long-term Effects of Continuous Positive Airway Pressure on Lipidemia and High-sensitivity C-reactive Protein Levels in Nonobese Patients With Coronary Heart Disease and Obstructive Sleep Apnea
The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and systemic inflammation.
The relationship regarding obstructive sleep apnea (OSA) and lipidemia and systemic inflammation is far from conclusion for obesity as a strong confounding factor.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Obstructive sleep apnea (OSA) is a common sleep disorder characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep, resulting in sleep fragmentation and oxyhemoglobin desaturation.
OSA is recognized as an important public health problem in developed country, affecting 9 and 24% of middle-aged females and males, respectively.
OSA, however, is not recognized as an abnormality for the majority and doesn't get more attention from most people in China.
Increasing evidence now indicates that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke.
Atherosclerosis is a key mechanism for these cardiovascular events.
Numerous studies have explored the relationship between hypertension and OSA.
And these studies confirms that OSA is an important identifiable cause of hypertension and a raised blood pressure has been shown to fall with effective continuous positive airway pressure (CPAP) treatment.
Dyslipidemia, an established independent risk factor for coronary heart disease (CHD) and atherosclerosis, is common in patients with OSA.
But there are limited interventional data on OSA and lipidemia, showing controversial results.
Several studies9,10 have shown a direct relationship between OSA and lipid profiles, independently of obesity, while other studies have demonstrated that obesity, as a confounding factor, contributed to dyslipidemia among OSA patients.11,12
Taken together, adiposity is a strong confounding factor for interpretation of the causal relationship between dyslipidemia and OSA.
Few studies have focused on nonobese patients.10,13
There are only a small number of randomized trials that have examined the effect of CPAP on fasting lipid profiles14,15 and none were specifically designed to evaluate the lipid profiles.
Furthermore, most studies assessed the impact of CPAP on OSA-related lipids without statin therapy.
In this way, it may be useful to avoid the disturb conditions due to statin treatment.
But it is impractical to those patients with OSA and CHD.
Since statins, in addition to decreasing hyperlipidemia levels, also inhibit inflammatory cytokines and play a critical role of plaque stabilization in CHD patients.
Similarly, the condition existed in the examination of high-sensitivity C-reactive protein (hs-CRP) in CHD subjects with OSA.
Therefore, the aims of the present study were (1) to establish whether CPAP therapy decreases lipid profiles and hs-CRP levels in nonobese patients with CHD and OSA, (2) to establish whether a relationship exists between the severity of OSA and levels of these circulating markers, and (3) to demonstrate a possible mechanism for the prevention of cardiovascular disease.
Studietype
Intervensjonell
Registrering (Faktiske)
78
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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Beijing, Kina, 100037
- Center of pulmonary vascular disease, Fuwai hospital
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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
45 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Participants diagnosed with a confirmation of CHD and moderate to severe
Exclusion Criteria:
- A body mass index (BMI) ≥ 25 kg/m2
- Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism
- A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis
- Pharmacological treatment that could affect lipids and hs-CRP levels
- Epworth Sleepiness Scale (ESS) ≥15
- Diagnosed with malignant cancer with a life expectancy of less than 1 years
- Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree
- Declined to participate or were unable to give informed consent.
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cpap
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CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night.
The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.
Andre navn:
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Ingen inngripen: No Cpap
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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lipid profiles
Tidsramme: baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
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plasma fasting lipid profiles were measured at baseline, 6months,and 12months.
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baseline, Change from baseline lipids at 6 months,Change from baseline lipids at 12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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High-sensitivity C-reactive protein
Tidsramme: baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months
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Fasting plasma high-sensitivity C-reactive protein was analyzed at baseline,6 months,and 12 months.
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baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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
1. januar 2010
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
24. april 2014
Først innsendt som oppfylte QC-kriteriene
28. april 2014
Først lagt ut (Anslag)
30. april 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
30. april 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. april 2014
Sist bekreftet
1. april 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Metabolske sykdommer
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Arteriosklerose
- Arterielle okklusive sykdommer
- Respirasjonsforstyrrelser
- Søvnforstyrrelser, iboende
- Dyssomnier
- Søvnvåkenforstyrrelser
- Tegn og symptomer, luftveier
- Lipidmetabolismeforstyrrelser
- Dyslipidemier
- Hjertesykdommer
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Søvnapné syndromer
- Søvnapné, obstruktiv
- Apné
- Hyperlipidemier
Andre studie-ID-numre
- SF2009
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