Continuous Monitoring Nocturnal Beat-to-beat Blood Pressure Fluctuation in OSA With or Without Hypertension
28 maart 2017 bijgewerkt door: Xu J, Huai'an No.1 People's Hospital
Huai'an First People's Hospital,Nanjing Medical University
Emerging evidence suggests that there is a causal link between obstructive sleep apnea(OSA) and hypertension.
Patient with this syndrome exhibit several characteristics: high prevalence, frequent non-dipper status, diastolic and nocturnal predominance, which are related to clinical and subclinical organ damage in heart and brain.
However, the influence of OSA on nocturnal hypertension development has not yet been clarified.
Blood pressure variability (BPV) plays a role in vascular damage, independent of blood pressure.
Apnea overloads the autonomic cardiovascular control system and may influence BPV,which is classified by different time interval, including beat-to-beat, hour-to-hour day-to-night changes or long-term, for example days, weeks, months, seasons, and even years.
All BPV abnormalities are associated with an increased incidence of cardiovascular events and mortality.
The investigators pre-experiment estimate BPV by ambulatory blood pressure monitoring (ABPM), which unable to capture the BP fluctuation accurately during the apnea event.
The small studies exam beat-to-beat BP and OSA，and the investigators can't couple the events with blood fluctuation, also incapable calculate the correlation of them.
This study is aimed to use pulse transmit time(PTT) based blood pressure measurement which can be useful for continuous monitoring of blood pressure to monitor nocturnal beat-to-beat blood pressure fluctuation in OSA with or without hypertension, investigating the degree of relevance between hypoxia, AHI, nocturnal hypertension development and BPV.
Besides that the investigators also evaluate the effect of continuous positive airway pressure(CPAP) on blood pressure and nocturnal beat-to-beat BPV.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
198
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Jiangsu
-
Huai'an, Jiangsu, China, 223300
- Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: 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
|
|
|
Ander: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Office hypertension
Tijdsspanne: 2 hours
|
as BP≧140/90mmHg on three different occasions (according to standard guidelines)
|
2 hours
|
|
nocturnal hypertension
Tijdsspanne: 1 night
|
as nighttime systolic blood pressure ≧120mmHg and/or70mmHg(diastolic blood pressure) |
1 night
|
|
hypoxemia
Tijdsspanne: 1 night
|
as the total time and the number of pulse oxygen less than 90% ,the minimum lowest pulse oxygen saturation during sleep
|
1 night
|
|
Beat-to-Beat BPV
Tijdsspanne: 1 night
|
as the a increase in systolic blood pressure(SPB) from baseline during an apnea event
|
1 night
|
|
BP event
Tijdsspanne: 1 night
|
the number of beat-to-beat BPV>10mmHg divided by sleep time
|
1 night
|
|
Apnea-hypopnea index(AHI)
Tijdsspanne: 1 night
|
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.
|
1 night
|
|
time of event
Tijdsspanne: 1 night
|
as the total time of apnea and hypopnea during sleep
|
1 night
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Zi Li Meng, Master, Huai'an first people's hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2016
Primaire voltooiing (Werkelijk)
27 maart 2017
Studie voltooiing (Werkelijk)
27 maart 2017
Studieregistratiedata
Eerst ingediend
10 augustus 2016
Eerst ingediend dat voldeed aan de QC-criteria
22 augustus 2016
Eerst geplaatst (Schatting)
23 augustus 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 maart 2017
Laatste update ingediend die voldeed aan QC-criteria
28 maart 2017
Laatst geverifieerd
1 maart 2017
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Huaian1PH
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .