Characteristics of Obstructive Sleep Apnea Syndrome Related Hypertension and the Effect of Continuous Positive Airway Pressure Treatment on Blood Pressure

NCT ID: NCT03246022

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 78 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-03
• Study Completion Date: 2021-12-30

Brief Summary

Obstructive sleep apnea syndrome (OSAS) causes nocturnal chronic intermittent hypoxia (CIH) that contributes to the development of hypertension. CIH profiles, including the its length, speed and intensity were widely different in individuals. Until recently, the influence of OSAS-related IH profiles on hypertension development has not been fully explored. The present study aimed to investigate the effects of different CIH properties on blood pressure (BP) and short-term blood pressure variability (BPV) in severe OSAS patients.

Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has been widely used in clinical. In theory, CPAP maintains upper airway patency and preserves ventilation, thereby inhibits the chain reaction over activation of the sympathetic nervous system and blood pressure regulating mechanism, thus CPAP treatment have adequate scientific basis to cause a substantial reduction arterial blood pressure, but controlled studies showed either no effect or only a minor decrease in arterial blood pressure by 1.4 and 2.5 mmHg respectively.The current, which type of combination of hypertension OSA patients can obtain the best antihypertensive benefit from CPAP therapy is still under debate.

Detailed Description

Nocturnal BP was continuously monitored via measurement of pulse transmit time (PTT). The value of apnea-related systolic BP elevation (△BP) was used to reflect short-term BPV. Beat-to-beat RR interval data were incorporated in polysomnography for heart rate variability analysis. LF/HF band ratio was compared between two groups which used to reflect sympatho-vagal balance. The length of the desaturation event was measured to the nearest 0.5 second (△t). The fall in SpO2 during apnea was calculated as the gap from start of the desaturation to the nadir of the desaturation. The rate of fall in SpO2 was counted as the change in the percentage of SpO2 per second (△SpO2 /△t) and expressed as oxygen desaturation rate (ODR), which reflected the speed and efficacy of oxygen desaturation during an apnea event. One hundred and two severe OSAS subjects were divided into two groups according to the their median ODR: faster ODR and slower ODR.

In addtion,patient were categorized into three groups: Group l: systolic blood pressure index was less than 30% of AHI; Group 2: systolic blood pressure index was less than 60% but more than 30%; Group 3: systolic blood pressure index is more than 60% of AHI. The investigator would compare the effect of CPAP treatment on awake and sleep BP level at the first night and 2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic nerve balance and the renin-angiotensin-aldosterone system are different in three groups would also be evaluated. The main purpose of study is to confirm the OSA with hypertension and OSA secondary hypertension are two different concepts. Basis for the clinical treatment, the former, CPAP might have no effect or only a minor decrease in arterial blood pressure, while the latter CPAP treatment might achieve significant antihypertensive effect.

Conditions

Hypertension Secondary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group l

SBP index was less than 30% of AHI

continuous positive airway pressure

Intervention Type: OTHER

Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has been widely used in clinical. The investigator would compare the effect of CPAP treatment on awake and sleep BP level at the first night and 2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic nerve balance and the renin-angiotensin-aldosterone system are different in three groups would also be evaluated.

Group 2

SBP index was less than 60% but more than 30%

continuous positive airway pressure

Intervention Type: OTHER

Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has been widely used in clinical. The investigator would compare the effect of CPAP treatment on awake and sleep BP level at the first night and 2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic nerve balance and the renin-angiotensin-aldosterone system are different in three groups would also be evaluated.

Interventions

continuous positive airway pressure

Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has been widely used in clinical. The investigator would compare the effect of CPAP treatment on awake and sleep BP level at the first night and 2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic nerve balance and the renin-angiotensin-aldosterone system are different in three groups would also be evaluated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. BP≤180/110mmHg,but≥140/90mmHg

Exclusion Criteria

(1) patients who had been hospitalized for cardiac or respiratory exacerbation<6wk prior to recruiting; (2) with autonomic nervous system diseases or endocrine disorders which might influence BP; (3) unwilling to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Huai'an No.1 People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZiLi Meng

The director of the of sleep center in Department of Respirology,Huai'an NO.1People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zili Meng, Master

Role: STUDY_DIRECTOR

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

Locations

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

Huai'an, Jiangsu, China

Countries

China

References

Meng Z, Chen Y, Yang T, Sun B, Luo C, Wei G, Xie X, Gu Y, Ding N, Zhang X, Xu J. New perspective on exploring the predictive factors of blood pressure reduction during CPAP treatment in people with severe OSA and hypertension: a prospective observational study. BMJ Open Respir Res. 2023 May;10(1):e001560. doi: 10.1136/bmjresp-2022-001560.

Reference Type: DERIVED

PMID: 37169401 (View on PubMed)

Wang N, Meng Z, Ding N, Chen W, Zhang X, Huang M, Xu J. Oxygen desaturation rate as a novel intermittent hypoxemia parameter in severe obstructive sleep apnea is strongly associated with hypertension. J Clin Sleep Med. 2020 Jul 15;16(7):1055-1062. doi: 10.5664/jcsm.8396.

Reference Type: DERIVED

PMID: 32105212 (View on PubMed)

Other Identifiers

Huaian First People's Hospital

Identifier Type: -

Identifier Source: org_study_id