Blood Pressure Disorders Clinical Trial
Official title:
Huai'an First People's Hospital,Nanjing Medical University
Verified date | March 2017 |
Source | Huai'an No.1 People's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 OSAļ¼and 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.
Status | Completed |
Enrollment | 198 |
Est. completion date | March 27, 2017 |
Est. primary completion date | March 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University | Huai'an | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Huai'an No.1 People's Hospital |
China,
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. — View Citation
Rothwell PM, Howard SC, Dolan E, O'Brien E, Dobson JE, Dahlöf 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. — View Citation
Steinhorst AP, Gonçalves 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Office hypertension | as BP?140/90mmHg on three different occasions (according to standard guidelines) | 2 hours | |
Primary | nocturnal hypertension | as nighttime systolic blood pressure ?120mmHg and/or70mmHg(diastolic blood pressure) |
1 night | |
Primary | hypoxemia | as the total time and the number of pulse oxygen less than 90% ,the minimum lowest pulse oxygen saturation during sleep | 1 night | |
Primary | Beat-to-Beat BPV | as the a increase in systolic blood pressure(SPB) from baseline during an apnea event | 1 night | |
Primary | BP event | the number of beat-to-beat BPV>10mmHg divided by sleep time | 1 night | |
Primary | Apnea-hypopnea index(AHI) | 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 | |
Primary | time of event | as the total time of apnea and hypopnea during sleep | 1 night |
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