Continuous Monitoring Nocturnal Beat-to-beat Blood Pressure Fluctuation in OSA With or Without Hypertension

NCT02876471 | Completed

• 1 other identifier: Huaian1PH
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure Disorders

Outcome Measures

Primary Outcomes (7)

• Office hypertension

  as BP≧140/90mmHg on three different occasions (according to standard guidelines)

  2 hours

• nocturnal hypertension

  as nighttime systolic blood pressure ≧120mmHg and/or70mmHg(diastolic blood pressure)

  1 night

• hypoxemia

  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

  as the a increase in systolic blood pressure(SPB) from baseline during an apnea event

  1 night

• BP event

  the number of beat-to-beat BPV\>10mmHg divided by sleep time

  1 night

• 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

• time of event

  as the total time of apnea and hypopnea during sleep

  1 night

Study Arms (2)

OSA group

NO INTERVENTION

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

OSA with hypertension

OTHER

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.

Other: CPAP

Interventions

CPAP OTHER

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

OSA with hypertension

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severity OSA (AHI\>30 episode/h)
• aged between 18 to 70 yeas
• blood pressure≦180/110mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Huai'an No.1 People's Hospital: lead

Study Sites (1)

Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University

Huai'an, Jiangsu, 223300, China

Location

Related Publications (5)

• 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.

  PMID: 20226988 BACKGROUND

• 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.

  PMID: 24092449 BACKGROUND

• 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.

  PMID: 22215704 BACKGROUND

• 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.

  PMID: 30637570 DERIVED

• 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.

  PMID: 29524090 DERIVED

Study Officials

• Zi Li Meng, Master

  Huai'an First People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of the sleep center in Huai'an NO.1People's Hospital

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 23, 2016
• Study Start: March 1, 2016
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)