- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02876471
Continuous Monitoring Nocturnal Beat-to-beat Blood Pressure Fluctuation in OSA With or Without Hypertension
Huai'an First People's Hospital,Nanjing Medical University
Přehled studie
Detailní popis
Methods:
Between March 2016 and December 2016,the investigators initially recruited 450 individuals reporting severe habitual snoring. Primal evaluations including office blood pressure, Epworth Sleepiness Scale Score(ESS), antihypertensive medicine demographic and anthropometric data. Then overnight polysomnography were performed. Of them,100 were severe OSA (AHI>30 episode/h) with hypertension, who were agreed to stop taking antihypertensive medicine. The investigators calculated the time to stop based on the half-life of patients taking oral drugs and last time administration time. The subject who withdrawal time was less than three days was enrolled in this study. These patients were hospitalized and close monitoring of blood pressure, for blood pressure three times greater than 180/110mmHg or appearing dizziness, headache and other clinical syndrome, the investigators will give a timely clinical intervention and get rid of this study. The control group consisted of 100 subjects just with severe OSA whose blood pressure is normal. The investigators recorded nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated. Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood pressure control, the investigators would give one-night continuous positive airway pressure(CPAP) to compare the AHI, the mean nocturnal systolic blood pressure and diastolic blood pressure, the number of blood events before and after short-term CPAP therapy, to compare the AHI, the mean nocturnal systolic blood pressure and diastolic blood pressure, the number of blood events before and after short-term CPAP therapy.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Jiangsu
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Huai'an, Jiangsu, Čína, 223300
- Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- severity OSA (AHI>30 episode/h)
- aged between 18 to 70 yeas
- blood pressure≦180/110mmHg
Exclusion Criteria:
- blood pressure>180/110mmHg
- severe clinical events such as coronary artery disease, heart failure,cerebrovascular disease or renal failure
- diabetes
- patients with suspected secondary hypertension
- patients with pulmonary disease being treated with bronchodilators, corticosteroids, or oxygen
- individuals who are able to perform the test
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: OSA group
100 severe OSA patients without hypertension were enrolled.
Primal evaluations including office blood pressure, Epworth sleepiness scale score(ESS),demographic and anthropometric data The full night polysomnogram was performed, recording nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated
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Jiný: OSA with hypertension
100 severe OSA patients with hypertension were enrolled.
Primal evaluations including office blood pressure, Epworth sleepiness scale score(ESS), antihypertensive medicine demographic and anthropometric data.
The full night polysomnogram was performed, recording nocturnal blood pressure, oximetry, beat-to-beat BPV, AHI, BP event was calculated.Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood pressure control, the investigators would give one-night CPAP.
|
OSA complicated with hypertension:In order to avoid the effects of drugs on this study, we calculated the time to stop based on the half-life of patients taking oral drugs and last time administration time.
The subject who withdrawal time was less than three days was enrolled in our study.
These patients were hospitalized and close monitoring of blood pressure, for blood pressure three times greater than 180/110mmHg or appearing dizziness, headache and other clinical syndrome, we give a timely clinical intervention and get rid of our study.
Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood control,the investigators would give one-night CPAP
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Office hypertension
Časové okno: 2 hours
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as BP≧140/90mmHg on three different occasions (according to standard guidelines)
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2 hours
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nocturnal hypertension
Časové okno: 1 night
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as nighttime systolic blood pressure ≧120mmHg and/or70mmHg(diastolic blood pressure) |
1 night
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hypoxemia
Časové okno: 1 night
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as the total time and the number of pulse oxygen less than 90% ,the minimum lowest pulse oxygen saturation during sleep
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1 night
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Beat-to-Beat BPV
Časové okno: 1 night
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as the a increase in systolic blood pressure(SPB) from baseline during an apnea event
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1 night
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BP event
Časové okno: 1 night
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the number of beat-to-beat BPV>10mmHg divided by sleep time
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1 night
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Apnea-hypopnea index(AHI)
Časové okno: 1 night
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AHI was defined as the number of apnea plus hypopnea episode per hour of sleep and was the summary measurement of the occurrence of sleep -disordered breathing.Apnea was defined as a reduction of airflow of at least 90% on the oronasal thermistor for at least 10s(it was considered obstructive if respiratory effort was absent).Hypopneas was scored when the magnitude of the signal decreased by at least 30% of the baseline amplitude of the nasal pressure transducer for at least 10s and was associated with a 4% or greater drop in oxygen saturation,as measured by finger pulse oximetry.
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1 night
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time of event
Časové okno: 1 night
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as the total time of apnea and hypopnea during sleep
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1 night
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Zi Li Meng, Master, Huai'an First People's Hospital
Publikace a užitečné odkazy
Obecné publikace
- Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlof B, Sever PS, Poulter NR. Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. Lancet. 2010 Mar 13;375(9718):895-905. doi: 10.1016/S0140-6736(10)60308-X.
- Steinhorst AP, Goncalves SC, Oliveira AT, Massierer D, Gus M, Fuchs SC, Moreira LB, Martinez D, Fuchs FD. Influence of sleep apnea severity on blood pressure variability of patients with hypertension. Sleep Breath. 2014 May;18(2):397-401. doi: 10.1007/s11325-013-0899-z. Epub 2013 Oct 3.
- Johansson JK, Niiranen TJ, Puukka PJ, Jula AM. Prognostic value of the variability in home-measured blood pressure and heart rate: the Finn-Home Study. Hypertension. 2012 Feb;59(2):212-8. doi: 10.1161/HYPERTENSIONAHA.111.178657. Epub 2012 Jan 3.
- Xu J, Ding N, Chen L, Zhang Y, Huang M, Wang Y, Meng Z, Zhang X. Inducers of post-apneic blood pressure fluctuation monitored by pulse transfer time measurement in obstructive sleep apnea varied with syndrome severity. Sleep Breath. 2019 Sep;23(3):769-776. doi: 10.1007/s11325-018-1770-z. Epub 2019 Jan 12.
- Xu J, Ding N, Zhang X, Wang N, Sun B, Zhang R, Xie X, Wan Z, Gu Y, Zhang S, Hong Y, Huang M, Meng Z. Nocturnal blood pressure fluctuation and associated influential factors in severe obstructive sleep apnea patients with hypertension. Sleep Breath. 2018 Dec;22(4):1045-1052. doi: 10.1007/s11325-018-1634-6. Epub 2018 Mar 9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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