New Perspective on Exploring the Post-apneic BP Surge in Patients With OSA
NCT ID: NCT06172998
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
350 participants
INTERVENTIONAL
2022-04-01
2024-06-01
Brief Summary
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Detailed Description
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First, about 300 suspected OSA and 50 healthy subjects under full-night polysomnography (PSG) will be recruited in the sleep medicine center of The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University and The First Affiliated Hospital with Nanjing Medical University. All the participants complete the questionnaire which includes clinical medical history, sleep habits, general health, smoking and drinking history, and anthropometric data. When PSG worked, BP was calculated by pulse transit time (PTT) simultaneously and continuously. The electrocardiography data extracted from the entire overnight PSG recordings are visually inspected for accuracy and quality and used for heart rate analysis (HRV) analysis. The next day, 4-5 mL peripheral venous blood samples are obtained from participants in the morning after an overnight fast and used for biochemical analysis. The sympathetic activity could be represented by HRV and Norepinephrine detected by enzyme-linked immunosorbent. Then, brachial artery diameter will be measured after the reactive hyperemia (called flow-mediated dilation, FMD) and nitroglycerin stimulus (called nitroglycerin-mediated dilation, NMD). The FMD and NMD could represent the vascular function. About 80 patients will be in the next plan. On the second day, under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. On the third day, under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction. The parameters before and after medicine will be analyzed and compared.
Hypothesis: The investigator predicted that patients who received phentolamine and nitroglycerin injections would lower nocturnal short-term BPV measured by polysomnography
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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healthy subject
No interventions assigned to this group
low BPV group
No interventions assigned to this group
high BPV group
Phentolamine Injection
Under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. Under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction.
Interventions
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Phentolamine Injection
Under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. Under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age from 18 to 65 years old.
Exclusion Criteria
* patients with comorbidities, such as hypertension, diabetes, cardiovascular diseases, and cerebrovascular diseases etc
* conditions that potentially affect the accuracy of BPV and endothelial function
* ever-received the treatment of constructive positive airway pressure (CPAP)
* who refuse to participate in the study.
18 Years
65 Years
ALL
Yes
Sponsors
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Xu J
OTHER
Responsible Party
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Xu J
professor
Locations
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Jing Xu
Huai'an, Jiangsu, China
Countries
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Facility Contacts
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Jing Xu, M.D
Role: primary
References
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Torres G, Sanchez-de-la-Torre M, Barbe F. Relationship Between OSA and Hypertension. Chest. 2015 Sep;148(3):824-832. doi: 10.1378/chest.15-0136.
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.
Sun B, Ma Q, Shen J, Meng Z, Xu J. Up-to-date advance in the relationship between OSA and stroke: a narrative review. Sleep Breath. 2024 Mar;28(1):53-60. doi: 10.1007/s11325-023-02904-2. Epub 2023 Aug 26.
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.
Schutte AE, Kollias A, Stergiou GS. Blood pressure and its variability: classic and novel measurement techniques. Nat Rev Cardiol. 2022 Oct;19(10):643-654. doi: 10.1038/s41569-022-00690-0. Epub 2022 Apr 19.
Sinski M, Lewandowski J, Przybylski J, Bidiuk J, Abramczyk P, Ciarka A, Gaciong Z. Tonic activity of carotid body chemoreceptors contributes to the increased sympathetic drive in essential hypertension. Hypertens Res. 2012 May;35(5):487-91. doi: 10.1038/hr.2011.209. Epub 2011 Dec 8.
Smith RP, Veale D, Pepin JL, Levy PA. Obstructive sleep apnoea and the autonomic nervous system. Sleep Med Rev. 1998 May;2(2):69-92. doi: 10.1016/s1087-0792(98)90001-6.
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Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8.
Rajendra Acharya U, Paul Joseph K, Kannathal N, Lim CM, Suri JS. Heart rate variability: a review. Med Biol Eng Comput. 2006 Dec;44(12):1031-51. doi: 10.1007/s11517-006-0119-0. Epub 2006 Nov 17.
van der Steen MS, Lenders JW, Graafsma SJ, den Arend J, Thien T. Reproducibility of ambulatory blood pressure monitoring in daily practice. J Hum Hypertens. 1999 May;13(5):303-8. doi: 10.1038/sj.jhh.1000808.
Gesche H, Grosskurth D, Kuchler G, Patzak A. Continuous blood pressure measurement by using the pulse transit time: comparison to a cuff-based method. Eur J Appl Physiol. 2012 Jan;112(1):309-15. doi: 10.1007/s00421-011-1983-3. Epub 2011 May 10.
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Meglic B, Danieli A. Glyceryl trinitrate-induced blood pressure variability decrease during head-up tilt test predicts vasovagal response. Blood Press Monit. 2023 Oct 1;28(5):236-243. doi: 10.1097/MBP.0000000000000653. Epub 2023 Jun 19.
Other Identifiers
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Huaian1PH8
Identifier Type: -
Identifier Source: org_study_id