<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246022</url>
  </required_header>
  <id_info>
    <org_study_id>Huaian First People's Hospital</org_study_id>
    <nct_id>NCT03246022</nct_id>
  </id_info>
  <brief_title>Characteristics of Obstructive Sleep Apnea Syndrome Related Hypertension and the Effect of Continuous Positive Airway Pressure Treatment on Blood Pressure</brief_title>
  <official_title>Huai'an First People's Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huai'an No.1 People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huai'an No.1 People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea syndrome (OSAS) causes nocturnal chronic intermittent hypoxia (CIH)&#xD;
      that contributes to the development of hypertension. CIH profiles, including the its length,&#xD;
      speed and intensity were widely different in individuals. Until recently, the influence of&#xD;
      OSAS-related IH profiles on hypertension development has not been fully explored. The present&#xD;
      study aimed to investigate the effects of different CIH properties on blood pressure (BP) and&#xD;
      short-term blood pressure variability (BPV) in severe OSAS patients.&#xD;
&#xD;
      Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the&#xD;
      occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has&#xD;
      been widely used in clinical. In theory, CPAP maintains upper airway patency and preserves&#xD;
      ventilation, thereby inhibits the chain reaction over activation of the sympathetic nervous&#xD;
      system and blood pressure regulating mechanism, thus CPAP treatment have adequate scientific&#xD;
      basis to cause a substantial reduction arterial blood pressure, but controlled studies showed&#xD;
      either no effect or only a minor decrease in arterial blood pressure by 1.4 and 2.5 mmHg&#xD;
      respectively.The current, which type of combination of hypertension OSA patients can obtain&#xD;
      the best antihypertensive benefit from CPAP therapy is still under debate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nocturnal BP was continuously monitored via measurement of pulse transmit time (PTT). The&#xD;
      value of apnea-related systolic BP elevation (△BP) was used to reflect short-term BPV.&#xD;
      Beat-to-beat RR interval data were incorporated in polysomnography for heart rate variability&#xD;
      analysis. LF/HF band ratio was compared between two groups which used to reflect&#xD;
      sympatho-vagal balance. The length of the desaturation event was measured to the nearest 0.5&#xD;
      second (△t). The fall in SpO2 during apnea was calculated as the gap from start of the&#xD;
      desaturation to the nadir of the desaturation. The rate of fall in SpO2 was counted as the&#xD;
      change in the percentage of SpO2 per second (△SpO2 /△t) and expressed as oxygen desaturation&#xD;
      rate (ODR), which reflected the speed and efficacy of oxygen desaturation during an apnea&#xD;
      event. One hundred and two severe OSAS subjects were divided into two groups according to the&#xD;
      their median ODR: faster ODR and slower ODR.&#xD;
&#xD;
      In addtion,patient were categorized into three groups: Group l: systolic blood pressure index&#xD;
      was less than 30% of AHI; Group 2: systolic blood pressure index was less than 60% but more&#xD;
      than 30%; Group 3: systolic blood pressure index is more than 60% of AHI. The investigator&#xD;
      would compare the effect of CPAP treatment on awake and sleep BP level at the first night and&#xD;
      2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic&#xD;
      nerve balance and the renin-angiotensin-aldosterone system are different in three groups&#xD;
      would also be evaluated. The main purpose of study is to confirm the OSA with hypertension&#xD;
      and OSA secondary hypertension are two different concepts. Basis for the clinical treatment,&#xD;
      the former, CPAP might have no effect or only a minor decrease in arterial blood pressure,&#xD;
      while the latter CPAP treatment might achieve significant antihypertensive effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2018</start_date>
  <completion_date type="Actual">December 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>awake systolic blood pressure(SBP)changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>as the mean systolic blood pressure measurements during a supine resting period of 1 0minute at awake state</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sleep systolic blood pressure(SBP)changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>as the average of systolic blood pressure values during sleep</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sympathetic-parasympathetic nerve balance changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>renin-angiotensin-aldosterone systemchanges</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>as the levels of plasma angiotension ⅰ( Ang I) and angiotension ⅱ( Ang ⅱ) before and after CPAP treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AHI changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>the combined number of apnea and hypopnea episodes per hour of sleep</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TST90 changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>percentage of sleep time with oxygen saturation &lt; 90%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oxygen desaturation index（ODI） changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>oxygen desaturation index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>event-related systolic blood pressure elevation (△SBP) changes</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>as the gap between the peak value of postapneic SBP and lowest SBP during a obstructive respiratory event</description>
  </primary_outcome>
  <primary_outcome>
    <measure>systolic blood pressure(SBP)index</measure>
    <time_frame>change from Baseline Systolic Blood Pressure at 2 weeks</time_frame>
    <description>as the number of △SBP&gt;10mmHg per hour of sleep time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Desaturation rate</measure>
    <time_frame>one night</time_frame>
    <description>The rate of fall in SpO2 was counted as the change in the percentage of SpO2 per second during apnea</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">78</enrollment>
  <condition>Hypertension Secondary</condition>
  <arm_group>
    <arm_group_label>Group l</arm_group_label>
    <description>SBP index was less than 30% of AHI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>SBP index was less than 60% but more than 30%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>continuous positive airway pressure</intervention_name>
    <description>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.</description>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group l</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. age between 18 to 70 yrs;&#xD;
&#xD;
          2. newly diagnosed OSAS without treatment;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. BP≤180/110mmHg,but≥140/90mmHg&#xD;
&#xD;
          2. without taking oral antihypertensive drugs. Exclusion criteria.&#xD;
&#xD;
        (1) patients who had been hospitalized for cardiac or respiratory exacerbation&lt;6wk prior to&#xD;
        recruiting; (2) with autonomic nervous system diseases or endocrine disorders which might&#xD;
        influence BP; (3) unwilling to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zili Meng, Master</last_name>
    <role>Study Director</role>
    <affiliation>Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University</name>
      <address>
        <city>Huai'an</city>
        <state>Jiangsu</state>
        <zip>223300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huai'an No.1 People's Hospital</investigator_affiliation>
    <investigator_full_name>ZiLi Meng</investigator_full_name>
    <investigator_title>The director of the of sleep center in Department of Respirology,Huai'an NO.1People's Hospital</investigator_title>
  </responsible_party>
  <keyword>blood pressure fluctuation</keyword>
  <keyword>hypertension</keyword>
  <keyword>continuous positive airway pressure</keyword>
  <keyword>intermittent hypixa</keyword>
  <keyword>oxygen desaturation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246022
org study id: Huaian First People's Hospital
nct id: NCT03246022
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: awake systolic blood pressure(SBP)changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: as the mean systolic blood pressure measurements during a supine resting period of 1 0minute at awake state
measure: sleep systolic blood pressure(SBP)changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: as the average of systolic blood pressure values during sleep
measure: sympathetic-parasympathetic nerve balance changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: 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
measure: renin-angiotensin-aldosterone systemchanges
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: as the levels of plasma angiotension ⅰ( Ang I) and angiotension ⅱ( Ang ⅱ) before and after CPAP treatment
measure: AHI changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: the combined number of apnea and hypopnea episodes per hour of sleep
measure: TST90 changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: percentage of sleep time with oxygen saturation < 90%
measure: oxygen desaturation index（ODI） changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: oxygen desaturation index
measure: event-related systolic blood pressure elevation (△SBP) changes
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: as the gap between the peak value of postapneic SBP and lowest SBP during a obstructive respiratory event
measure: systolic blood pressure(SBP)index
time frame: change from Baseline Systolic Blood Pressure at 2 weeks
description: as the number of △SBP>10mmHg per hour of sleep time.
measure: Desaturation rate
time frame: one night
description: The rate of fall in SpO2 was counted as the change in the percentage of SpO2 per second during apnea
arm group label: Group l
description: SBP index was less than 30% of AHI
arm group label: Group 2
description: SBP index was less than 60% but more than 30%
intervention type: Other
intervention name: continuous positive airway pressure
description: 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.
arm group label: Group 2
arm group label: Group l
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zili Meng, Master
role: Study Director
affiliation: Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huai'an No.1 People's Hospital
investigator full name: ZiLi Meng
investigator title: The director of the of sleep center in Department of Respirology,Huai'an NO.1People's Hospital
mesh term: Hypertension
sharing ipd: No