Hypertension SecondaryNCT03246022
Characteristics of Obstructive Sleep Apnea Syndrome Related Hypertension and the Effect of Continuous Positive Airway Pressure Treatment on Blood Pressure
An observational study of Hypertension Secondary, run by Huai'an No.1 People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension Secondary
- What is being tested?
- continuous positive airway pressure
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2018to 30 Dec 2021
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. age between 18 to 70 yrs; 2. newly diagnosed OSAS without treatment;
Who may be able to join
- BP≤180/110mmHg,but≥140/90mmHg
- without taking oral antihypertensive drugs. Exclusion criteria.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
Huai'an, Jiangsu, 223300
About this study
Official title: Huai'an First People's Hospital
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.
Read the 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
- Being tested
- continuous positive airway pressure
- Keywords
- blood pressure fluctuation, hypertension, continuous positive airway pressure, intermittent hypixa, oxygen desaturation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group l | SBP index was less than 30% of AHI Receives: Other: continuous positive airway pressure | |
| Group 2 | SBP index was less than 60% but more than 30% Receives: Other: continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
awake systolic blood pressure(SBP)changes
as the mean systolic blood pressure measurements during a supine resting period of 1 0minute at awake state
Measured: 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
Measured: 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
Measured: 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
Measured: change from Baseline Systolic Blood Pressure at 2 weeks
AHI changes
the combined number of apnea and hypopnea episodes per hour of sleep
Measured: change from Baseline Systolic Blood Pressure at 2 weeks
TST90 changes
percentage of sleep time with oxygen saturation < 90%
Measured: change from Baseline Systolic Blood Pressure at 2 weeks
oxygen desaturation index（ODI） changes
oxygen desaturation index
Measured: 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
Measured: 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.
Measured: 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
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start3 Apr 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Huai'an No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZiLi Meng, Huai'an No.1 People's Hospital
- Investigators
- Zili Meng, Master, Study director, Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246022
- Sponsor's protocol ID
- Huaian First People's Hospital
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2017
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37169401Wang 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.
PubMed 32105212
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Huai'an First People's Hospital
- ClinicalTrials.gov ID
- NCT03246022
- Acronym / sponsor ID
- Huaian First People's Hospital
- Conditions
- Hypertension Secondary
- Keywords
- blood pressure fluctuation, hypertension, continuous positive airway pressure, intermittent hypixa, oxygen desaturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Huai'an No.1 People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group l | – | Other: continuous positive airway pressureSBP index was less than 30% of AHI |
| Group 2 | – | Other: continuous positive airway pressureSBP index was less than 60% but more than 30% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. age between 18 to 70 yrs; 2. newly diagnosed OSAS without treatment;
Key inclusion criteria (3 listed)
- BP≤180/110mmHg,but≥140/90mmHg
- without taking oral antihypertensive drugs. Exclusion criteria.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous 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. | Other | Group 2, Group l |
Primary outcome
awake systolic blood pressure(SBP)changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
as the mean systolic blood pressure measurements during a supine resting period of 1 0minute at awake state
sleep systolic blood pressure(SBP)changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
as the average of systolic blood pressure values during sleep
sympathetic-parasympathetic nerve balance changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
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
renin-angiotensin-aldosterone systemchanges
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
as the levels of plasma angiotension ⅰ( Ang I) and angiotension ⅱ( Ang ⅱ) before and after CPAP treatment
AHI changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
the combined number of apnea and hypopnea episodes per hour of sleep
TST90 changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
percentage of sleep time with oxygen saturation < 90%
oxygen desaturation index（ODI） changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
oxygen desaturation index
event-related systolic blood pressure elevation (△SBP) changes
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
as the gap between the peak value of postapneic SBP and lowest SBP during a obstructive respiratory event
systolic blood pressure(SBP)index
Time frame: change from Baseline Systolic Blood Pressure at 2 weeks
as the number of △SBP>10mmHg per hour of sleep time.
Desaturation rate
Time frame: one night
The rate of fall in SpO2 was counted as the change in the percentage of SpO2 per second during apnea
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 37169401Meng 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.
- Derived from this study: PubMed 32105212Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zili Meng, Master study director
Department Of Respiratory Medicine,Huai'an First People's Hospital,Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension Secondary, run by Huai'an No.1 People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
awake systolic blood pressure(SBP)changes (time frame: change from Baseline Systolic Blood Pressure at 2 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03246022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.