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

NCT03246022 | Completed DMC

• 1 other identifier: Huaian First People's Hospital
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension Secondary

Keywords

blood pressure fluctuation; hypertension; continuous positive airway pressure; intermittent hypixa; oxygen desaturation

Outcome Measures

Primary Outcomes (10)

• awake systolic blood pressure(SBP)changes

  as the mean systolic blood pressure measurements during a supine resting period of 1 0minute at awake state

  change from Baseline Systolic Blood Pressure at 2 weeks

• sleep systolic blood pressure(SBP)changes

  as the average of systolic blood pressure values during sleep

  change from Baseline Systolic Blood Pressure at 2 weeks

• sympathetic-parasympathetic nerve balance changes

  Studies using spectral analysis of R-R intervals have reported that the power spectrum contains both low-frequency(LF,0.04-0.15 Hz)and high-frequency peaks(HF,0.15-0.5Hz),HF power reflects parasympathetic activity,whereas LF power primarily reflects sympathetic activity with a parasympathetic component.The LF-to-HF ratio(LF/HF)is commonly regarded as an index of sympathovagal balance

  change from Baseline Systolic Blood Pressure at 2 weeks

• renin-angiotensin-aldosterone systemchanges

  as the levels of plasma angiotension ⅰ( Ang I) and angiotension ⅱ( Ang ⅱ) before and after CPAP treatment

  change from Baseline Systolic Blood Pressure at 2 weeks

• AHI changes

  the combined number of apnea and hypopnea episodes per hour of sleep

  change from Baseline Systolic Blood Pressure at 2 weeks

• TST90 changes

  percentage of sleep time with oxygen saturation \< 90%

  change from Baseline Systolic Blood Pressure at 2 weeks

• oxygen desaturation index（ODI） changes

  oxygen desaturation index

  change from Baseline Systolic Blood Pressure at 2 weeks

• event-related systolic blood pressure elevation (△SBP) changes

  as the gap between the peak value of postapneic SBP and lowest SBP during a obstructive respiratory event

  change from Baseline Systolic Blood Pressure at 2 weeks

• systolic blood pressure(SBP)index

  as the number of △SBP\>10mmHg per hour of sleep time.

  change from Baseline Systolic Blood Pressure at 2 weeks

• Desaturation rate

  The rate of fall in SpO2 was counted as the change in the percentage of SpO2 per second during apnea

  one night

Study Arms (2)

Group l

SBP index was less than 30% of AHI

Other: continuous positive airway pressure

Group 2

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

Other: continuous positive airway pressure

Interventions

continuous positive airway pressure 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; Group l

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. age between 18 to 70 yrs; 2. newly diagnosed OSAS without treatment;

You may qualify if:

• BP≤180/110mmHg,but≥140/90mmHg

You may not qualify if:

• (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.

Sponsors & Collaborators

• Huai'an No.1 People's Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (1)

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

Huai'an, Jiangsu, 223300, China

Location

Related Publications (2)

• 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.

  PMID: 37169401 DERIVED

• 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.

  PMID: 32105212 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Zili Meng, Master

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the of sleep center in Department of Respirology,Huai'an NO.1People's Hospital

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: August 11, 2017
• Study Start: April 3, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 29, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)