- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02059993
The Effects of Obstructive Sleep Apnea and Its Intervention on Coronary Heart Disease
14 juli 2020 uppdaterad av: Chinese Pulmonary Vascular Disease Research Group
Obstructive sleep apnea(OSA) is an important identifiable cause of hypertension.
Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.The standardized treatment of moderate/severe OSA is continuous positive airway pressure (CPAP).
Most of short-term trials indicated that CPAP treatment reduced BP in patients with OSA.
But relevant studies have a relative short duration with only but few more than one year.
In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP.
Besides, the impact of OSA on metabolic disorder is still unclear.We hypothesized that long-term CPAP treatment could reduce blood pressure and improve metabolic disorder in patients with coronary heart disease (CHD)and OSA.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Obstructive sleep apnea (OSA) is a common disorder characterized by repetitive partial (hypopnea) or complete (apnea) occlusion of the upper airway during sleep caused by collapse of the pharyngeal airway, resulting in sleep fragmentation and oxyhemoglobin desaturation.
Kiely and colleague's study showed that over 20% of hypertensive patients exhibit OSA, whereas prevalence of hypertension in the setting of OSA exceeds 50%.
One study confirmed that OSA is an important identifiable cause of hypertension.
OSA is considered as one of the most common risk factors of resistant hypertension.
Previous study has suggested that OSA significantly increases cardiovascular morbidity and mortality, especially in patients with pre-existing cardiovascular disease.
Several studies confirmed that CPAP reduced systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with OSA.
Additionally, some papers reported that there was a protective effect of CPAP therapy against death from cardiovascular disease in patients with severe OSA.
Other researches regarding the antihypertensive effect of CPAP therapy, however, showed that CPAP had no antihypertensive effect.
But relevant studies have a relative short duration with only but few more than one year.
In our opinion, they are not sufficient to detect the real effect of CPAP on reduction in BP.
According to our knowledge, there is no report about long-term effect of CPAP on BP in hypertensive patients with coronary revascularization (CRV) and OSA under conventional antihypertensive medications.
Therefore, we conducted a long-term, prospective controlled study to investigate the effects of CPAP on BP, metabolic disorder, clinical symptoms, cardiovascular and cerebrovascular events in patients with CHD and OSA on conventional treatment.
Studietyp
Interventionell
Inskrivning (Faktisk)
83
Fas
- Inte tillämpbar
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
45 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- men and women, aged 45 to 75 years old
- verified diagnosis of hypertension by medical history or receiving antihypertensive drugs
- established diagnosis of CHD
- at least 3-month optimal treatment for hypertension
- moderate or severe OSA
Exclusion Criteria:
- if they had secondary hypertension
- central sleep apneas
- history of significant chronic renal, or hepatic failure or severe pulmonary disease
- diagnosed with malignant cancer with a life expectancy of less than 2years
- regular use of medications that can affect BP(including corticosteroids or sedative drugs)
- severe psychiatric disease
- sustained excessive alcohol use
- current use of CPAP treatment for OSA or pharyngeal surgery for OSA
- New York Heart Association Class III-IV degree
- declined to participate or were unable to give informed consent
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: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Övrig: continuous positive airway pressure
mean continuous positive airway pressure use was at least 4 hours per night; continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
|
mean continuous positive airway pressure use was at least 4 hours per night;continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
|
Inget ingripande: Control
The control subjects received standardised anti-hypertension medications according to the current guildline.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment
Tidsram: baseline and follow-up at 36 months
|
baseline and follow-up at 36 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Epworth Sleepiness Scale (ESS)
Tidsram: baseline,end of study ( up to 54 months)
|
The epworth sleepiness scale(ESS) measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP).
It is a simple questionnaire based on retrospective reports of the likelihood of dozing off or falling asleep in a variety of different situations.
The ESS is the most commonly used method for measuring a person's ASP.The ESS ranges from 0-24, higher scores indicate more severe daytime sleepiness.
|
baseline,end of study ( up to 54 months)
|
Andra resultatmått
Resultatmått |
Tidsram |
---|---|
Cardiovascular and Cerebrovascular Events
Tidsram: Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month
|
Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Zhihong Liu, MD,PhD, Fuwai Hospital, National Center for Cardiovascular Diseases
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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
1 januari 2009
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 december 2013
Studieregistreringsdatum
Först inskickad
9 februari 2014
Först inskickad som uppfyllde QC-kriterierna
10 februari 2014
Första postat (Uppskatta)
11 februari 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juli 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juli 2020
Senast verifierad
1 juli 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Sjukdomar i nervsystemet
- Luftvägssjukdomar
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Apné
- Andningsstörningar
- Sömnstörningar, inneboende
- Dyssomni
- Vakna sömnstörningar
- Hjärtsjukdom
- Kranskärlssjukdom
- Myokardischemi
- Kranskärlssjukdom
- Sömnapnésyndrom
- Sömnapné, obstruktiv
- Hypertoni
- Metaboliska sjukdomar
Andra studie-ID-nummer
- SF2009-2012
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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