Clinical Trials Directory

Trials / Completed

CompletedNCT03246022

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

Huai'an First People's Hospital

Status
Completed
Phase
Study type
Observational
Enrollment
78 (actual)
Sponsor
Huai'an No.1 People's Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERcontinuous positive airway pressureContinuous 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.

Timeline

Start date
2018-04-03
Primary completion
2021-12-30
Completion
2021-12-30
First posted
2017-08-11
Last updated
2022-03-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03246022. Inclusion in this directory is not an endorsement.