Sleep Apnea, ObstructivePISA-BPNCT03176732
Mechanisms for Individual Differences in Hypertension in Obstructive Sleep
An observational study of Sleep Apnea, Obstructive and Hypertension, run by University of Pennsylvania at 2 sites in 2 countries.
Trial summary
Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all individuals with OSA have hypertension and there are major individual differences in blood pressure response to positive airway pressure treatment of OSA. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Hypertension
- What is being tested?
- Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2017to 30 Jun 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult subjects between the ages of 18 and 75 years of age with a diagnosis of untreated moderate to severe OSA as evidenced by an apnea/hypopnea index ≥ 15 events/hour who are about to be initiated on PAP treatment. We will make a conscious effort to recruit from all ethnic and social economic backgrounds.
Who may be able to join
- Age between 18 and 75 years
- Apnea-Hypopnea Index (AHI) ≥ 15 events/hr on diagnostic polysomnography(PSG)
- No previous history of surgical treatment of OSA, and no medical treatment of OSA within the past 6 months
- Adherence to prescribed anti-hypertensive medications as assessed by an average adherence between Visits 1-2 of at least 0.85
- Arm circumference less than 50 cm
Who cannot join
- Unable or unwilling to provide informed consent
- No telephone access or inability to return for follow-up
- Diagnosis of another sleep disorder in addition to OSA (e.g., periodic limb movement disorder [greater than 5 limb movements associated with arousal/hr of sleep], central sleep apnea [greater than 50% of apneas are central apneas], obesity hypoventilation syndrome, narcolepsy)
- Positive urine drug screen for any of the following: amphetamines, cocaine, opiates, barbiturates, benzodiazepines, phencyclidine (PCP), alcohol (ETOH), methadone (Visit 1)
- Requiring oxygen, bi-level positive airway pressure, or adaptive servo-ventilation for treatment of OSA
- Oxygen saturation < 87% for a period of 2 minutes during resting wakefulness during home sleep testing (HST) or PSG (Visit 2)
Show all 13Show fewer
- Severe and inadequately controlled arterial hypertension (SBP greater than 180 mm Hg; diastolic BP greater than 110 mm Hg on 2 of 3 spot measurements on Visit 1)
- Participants with 24-hr SBP ≥ 140 mm Hg who are not on BP medications and participants on 4 or more BP medications with a 24-hr SBP < 135 mm Hg (Visit 2)
- A clinically unstable medical condition as defined by a change in medications in the previous month, including anti-hypertensive medications, or a new medical diagnosis in the previous 2 months (e.g., myocardial infarction, chronic heart failure, unstable angina, active infection, thyroid disease, depression or psychosis, cirrhosis, surgery, or cancer)
- Shift workers, individuals who regularly experience jet lag, or have irregular work schedules by history over the last 3 months
- Women who are pregnant or sexually active and of child-bearing age not using a form of contraceptive
- Routine consumption of > 2 alcoholic beverages/day Excessive use of caffeine (greater than 10 cups/day)
- Inability to communicate verbally or less than a 5th grade reading level
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all individuals with OSA have hypertension and there are major individual differences in blood pressure response to positive airway pressure treatment of OSA. This project is focused on determining the basis of these individual differences in blood pressure response to OSA and will evaluate the possible underlying reasons for these differences. The results will help clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA treatment in a given patient and thereby personalize patient management.
Read the detailed description
We seek to assess the clinical determinants and molecular/genetic mechanisms underlying known individual differences in BP response to obstructive sleep apnea (OSA). This will result in a more personalized approach to BP management of OSA patients. Hypertension is a common consequence of OSA. Animal studies with cyclical intermittent hypoxia indicate that oxidative stress is likely the major mechanism, but cardiovascular response to arousals may also play a role. However, not all individuals with OSA have hypertension. Moreover, recent meta-analyses of treatment trials of OSA show major individual differences in BP response. The largest drop in BP with positive airway pressure (PAP) therapy for OSA is in patients with resistant hypertension taking three or more BP medications. This project is focused on determining the basis of these individual differences in BP response to OSA and PAP treatment. For Aim 1, we will assemble four groups of OSA subjects with: 1) no hypertension; 2) controlled hypertension on medications and/or lifestyle modifications; 3) uncontrolled hyper-tension despite one or two anti-hypertensive medications; and 4) resistant hypertension. We will assess reductions in BP with PAP therapy with mean nocturnal (sleep) arterial BP being the primary end-point. The prediction is that group 4 will show the largest fall in BP, even after controlling for relevant covariates, group 3 the next biggest fall, while groups 1 and 2 will show minimal BP changes. Both intent to treat and per protocol analyses, i.e., analyzing only those subjects who had PAP adherence of ≥ 4 hours/day and are adherent to medication, will be conducted. All subjects will have the following measured before and after 4 months of therapy: urinary isoprostanes and plasma levels of norepinephrine, renin activity, aldosterone, oxidized LDL, endothelin-1, and inflammatory biomarkers. In Aim 2, we hypothesize that those individuals with higher BP at baseline and the greatest BP response to PAP therapy will have higher levels of urinary isoprostanes and plasma norepinephrine at baseline and greater falls with therapy. Animal studies show that the key enzyme mediating oxidative stress in OSA is nicotinamide adenine dinucleotide phosphate-oxidase (NADPH) oxidase (NOX), in particular NOX2. Thus, NADPH oxidase activity will also be assessed. Individuals with the largest falls in BP on PAP therapy are hypothesized to have the highest activity of this enzyme at baseline. There are known genetic variants of this enzyme that affect its structure/activity. Thus, individual differences could be the result of genetic variants. To address this, we will employ in-depth sequencing and evaluate variants in 7 key genes regulating NOX2 structure/activity. Gene variants identified will be related to BP responses and to NADPH oxidase activity. In Aim 3, the role of arousals in the BP response to OSA will be assessed using a novel measurement of heart rate response to arousal. We hypothesize that the heart rate response to arousal will be related to the BP and molecular outcomes of Aims 1 and 2. Finally, given the complex relationship between OSA and BP, Aim 4 will utilize structural equation modeling to assess the relative impact of the various biological pathways.
- Conditions
- Sleep Apnea, Obstructive, Hypertension
- Being tested
- Positive Airway Pressure
- Keywords
- Sleep Apnea, Hypertension, Positive Airway Pressure, Blood Pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway PressureDevice
Participants will use Positive Airway Pressure (PAP) treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Normotensive | Categorized by 24-hr systolic BP (SBP): normotensive (< 125 mm Hg) on no BP medications Receives: Device: Positive Airway Pressure | |
| Group 2: Controlled Hypertensive | Categorized by 24-hr systolic BP (SBP): controlled hypertensive (< 130 mm Hg) on BP medication(s) and/or lifestyle modification Receives: Device: Positive Airway Pressure | |
| Group 3: Uncontrolled Hypertensive | Categorized by 24-hr systolic BP (SBP): uncontrolled hypertensive (≥ 130 mm Hg) on 0-2 BP medications Receives: Device: Positive Airway Pressure | |
| Group 4: Hypertensive | Categorized by 24-hr systolic BP (SBP): hypertensive (≥ 135 mm Hg) resistant to 3 or more BP medications ideally including a diuretic (resistant hypertension) Receives: Device: Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal mean arterial blood pressure (nMAP)
Measured using 24-hour ambulatory blood pressure monitoring
Measured: Measured for 24-hours at baseline and repeated after 4 months of PAP treatment.
Secondary outcomes (2)
Oxidative stress
Measured in urinary 8-isoprostane.
Measured: Collected overnight at baseline and repeated after 4 months of PAP treatment.
Sympathetic activity
Measured in blood plasma
Measured: Fasting blood draw collected at baseline and repeated after 4 months of PAP treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start6 Jun 2017
- Primary completion30 Apr 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Samuel T Kuna, MD, Principal investigator, University of PennsylvaniaRaymond R Townsend, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176732
- Sponsor's protocol ID
- 823172
- Other IDs
- P01HL094307-06A1
- Acronym
- PISA-BP
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2017
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms for Individual Differences in Hypertension in Obstructive Sleep
- ClinicalTrials.gov ID
- NCT03176732
- Acronym / sponsor ID
- PISA-BP / 823172
- Conditions
- Sleep Apnea, Obstructive, Hypertension
- Keywords
- Sleep Apnea, Hypertension, Positive Airway Pressure, Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Jun 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.
Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all individuals with OSA have hypertension and there are major individual differences in blood pressure response to positive airway pressure treatment of OSA. This project is focused on determining the basis of these individual differences in blood pressure response to OSA and will evaluate the possible underlying reasons for these differences. The results will help clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA treatment in a given patient and thereby personalize patient management.
Detailed description
We seek to assess the clinical determinants and molecular/genetic mechanisms underlying known individual differences in BP response to obstructive sleep apnea (OSA). This will result in a more personalized approach to BP management of OSA patients. Hypertension is a common consequence of OSA. Animal studies with cyclical intermittent hypoxia indicate that oxidative stress is likely the major mechanism, but cardiovascular response to arousals may also play a role. However, not all individuals with OSA have hypertension. Moreover, recent meta-analyses of treatment trials of OSA show major individual differences in BP response. The largest drop in BP with positive airway pressure (PAP) therapy for OSA is in patients with resistant hypertension taking three or more BP medications. This project is focused on determining the basis of these individual differences in BP response to OSA and PAP treatment. For Aim 1, we will assemble four groups of OSA subjects with: 1) no hypertension; 2) controlled hypertension on medications and/or lifestyle modifications; 3) uncontrolled hyper-tension despite one or two anti-hypertensive medications; and 4) resistant hypertension. We will assess reductions in BP with PAP therapy with mean nocturnal (sleep) arterial BP being the primary end-point. The prediction is that group 4 will show the largest fall in BP, even after controlling for relevant covariates, group 3 the next biggest fall, while groups 1 and 2 will show minimal BP changes. Both intent to treat and per protocol analyses, i.e., analyzing only those subjects who had PAP adherence of ≥ 4 hours/day and are adherent to medication, will be conducted. All subjects will have the following measured before and after 4 months of therapy: urinary isoprostanes and plasma levels of norepinephrine, renin activity, aldosterone, oxidized LDL, endothelin-1, and inflammatory biomarkers. In Aim 2, we hypothesize that those individuals with higher BP at baseline and the greatest BP response to PAP therapy will have higher levels of urinary isoprostanes and plasma norepinephrine at baseline and greater falls with therapy. Animal studies show that the key enzyme mediating oxidative stress in OSA is nicotinamide adenine dinucleotide phosphate-oxidase (NADPH) oxidase (NOX), in particular NOX2. Thus, NADPH oxidase activity will also be assessed. Individuals with the largest falls in BP on PAP therapy are hypothesized to have the highest activity of this enzyme at baseline. There are known genetic variants of this enzyme that affect its structure/activity. Thus, individual differences could be the result of genetic variants. To address this, we will employ in-depth sequencing and evaluate variants in 7 key genes regulating NOX2 structure/activity. Gene variants identified will be related to BP responses and to NADPH oxidase activity. In Aim 3, the role of arousals in the BP response to OSA will be assessed using a novel measurement of heart rate response to arousal. We hypothesize that the heart rate response to arousal will be related to the BP and molecular outcomes of Aims 1 and 2. Finally, given the complex relationship between OSA and BP, Aim 4 will utilize structural equation modeling to assess the relative impact of the various biological pathways.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Normotensive | – | Device: Positive Airway PressureCategorized by 24-hr systolic BP (SBP): normotensive (< 125 mm Hg) on no BP medications |
| Group 2: Controlled Hypertensive | – | Device: Positive Airway PressureCategorized by 24-hr systolic BP (SBP): controlled hypertensive (< 130 mm Hg) on BP medication(s) and/or lifestyle modification |
| Group 3: Uncontrolled Hypertensive | – | Device: Positive Airway PressureCategorized by 24-hr systolic BP (SBP): uncontrolled hypertensive (≥ 130 mm Hg) on 0-2 BP medications |
| Group 4: Hypertensive | – | Device: Positive Airway PressureCategorized by 24-hr systolic BP (SBP): hypertensive (≥ 135 mm Hg) resistant to 3 or more BP medications ideally including a diuretic (resistant hypertension) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects between the ages of 18 and 75 years of age with a diagnosis of untreated moderate to severe OSA as evidenced by an apnea/hypopnea index ≥ 15 events/hour who are about to be initiated on PAP treatment. We will make a conscious effort to recruit from all ethnic and social economic backgrounds.
Key inclusion criteria (5 listed)
- Age between 18 and 75 years
- Apnea-Hypopnea Index (AHI) ≥ 15 events/hr on diagnostic polysomnography(PSG)
- No previous history of surgical treatment of OSA, and no medical treatment of OSA within the past 6 months
- Adherence to prescribed anti-hypertensive medications as assessed by an average adherence between Visits 1-2 of at least 0.85
- Arm circumference less than 50 cm
Key exclusion criteria (13 listed)
- Unable or unwilling to provide informed consent
- No telephone access or inability to return for follow-up
- Diagnosis of another sleep disorder in addition to OSA (e.g., periodic limb movement disorder [greater than 5 limb movements associated with arousal/hr of sleep], central sleep apnea [greater than 50% of apneas are central apneas], obesity hypoventilation syndrome, narcolepsy)
- Positive urine drug screen for any of the following: amphetamines, cocaine, opiates, barbiturates, benzodiazepines, phencyclidine (PCP), alcohol (ETOH), methadone (Visit 1)
- Requiring oxygen, bi-level positive airway pressure, or adaptive servo-ventilation for treatment of OSA
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 |
|---|---|---|
| Positive Airway PressureParticipants will use Positive Airway Pressure (PAP) treatment | Device | Group 1: Normotensive, Group 2: Controlled Hypertensive, Group 3: Uncontrolled Hypertensive, Group 4: Hypertensive |
Primary outcome
Nocturnal mean arterial blood pressure (nMAP)
Time frame: Measured for 24-hours at baseline and repeated after 4 months of PAP treatment.
Measured using 24-hour ambulatory blood pressure monitoring
2 secondary outcomes
Oxidative stress
Time frame: Collected overnight at baseline and repeated after 4 months of PAP treatment.
Sympathetic activity
Time frame: Fasting blood draw collected at baseline and repeated after 4 months of PAP treatment.
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 26 Apr 2023.
- 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.
Samuel T Kuna, MD principal investigator
University of Pennsylvania
Raymond R Townsend, MD principal investigator
University of Pennsylvania
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Hypertension, run by University of Pennsylvania at 2 sites in 2 countries.
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 5 inclusion and 13 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 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Iceland. 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?
Nocturnal mean arterial blood pressure (nMAP) (time frame: Measured for 24-hours at baseline and repeated after 4 months of PAP treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2023; AzTrials last refreshed its copy on 31 Oct 2026.