Obstructive Sleep ApneaAHPAPNCT05115994
Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension (AHPAP)
An observational study of Obstructive Sleep Apnea and Hypertension, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The investigators will perform a long term registry based prospective analysis on incidence of major cardiovascular events or death in hypertensive patients with obstructive sleep apnea . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension, Death, Cardiac
- What is being tested?
- Continous positive airway pressure
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Dec 2026
- How long will I take part?
- 14 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Propensity score matched registry cohorts
Who may be able to join
- All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.
Who cannot join
- Patients in the hypertensive control group (without OSA) will be excluded if they have OSA diagnosis but are not present in the SESAR registry.
- Subjects with missing data on any of the variables in the fitted model unless the missing data can be accurately imputated.
- Patients with low life expectancy (Age>75 at study start, malignant disease).
- Patients no longer living in VGR 2021.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
About this study
Official title: Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)
The investigators will perform a long term registry based prospective analysis on incidence of major cardiovascular events or death in hypertensive patients with obstructive sleep apnea .
Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.
Read the detailed description
By using swedish personal ID numbers the investigators can combine data from several quality registries in Sweden and will start with patients from a primary care registry (QregPV) that had or received a hypertension diagnosis during the period 2008-2012. The investigators will compare those who got an OSA diagnosis in the SESAR (Swedish sleep apnea registry) stratified by high/low PAP compliance with an intraoral device group, a non treated OSA group as well as a control group without OSA until 2021. Main outcome variables will be major cardiovascular events or death. Outcome data will be collected from the National Patient Registry and Cause of death registry.
Groups will be matched by propensity score for known confounders. Secondary analysis will consider modifying effect of different antihypertensive drugs (the Swedish Prescribed Drug Register, type of therapy; DDD comparison) and the actual degree of hypertension control (blood pressure levels) on CV risk. It is intended to stratify the analysis for BP levels in order to evaluate if lower BP targets further reduce CV risk in hypertensive OSA patients. These analyses will likely be reported in separate publications.
HYPOTHESIS
- PAP treatment in hypertensive OSA patients reduces the long term risk of major cardiovascular events (MCE) and premature death. The risk reduction is modified by PAP compliance, hypertension control and OSA severity.
- In hypertensive OSA patients, the investigators previously identified betablockade as a drug class leading to better pressure control (1). The investigators hypothesize that any risk reduction by PAP treated OSA is influenced by the types of antihypertensive drugs used.
- Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.
- Conditions
- Obstructive Sleep Apnea, Hypertension, Death, Cardiac, Treatment Compliance, Heart Failure, Stroke
- Being tested
- Continous positive airway pressure
- Keywords
- Continous positive airway pressure, Antihypertensive treatment, Risc prevention
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension, Death, Patient Compliance, Heart Failure, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous positive airway pressureDevice
Also called Antihypertensive pharmacological treatment
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive OSA patients, high PAP compliance | Hypertensive OSA patients using their PAP device for at least 4 hrs/night Receives: Device: Continous positive airway pressure | |
| Hypertensive OSA patients, low PAP compliance | Hypertensive OSA patients using their PAP device for less than 4 hrs/night Receives: Device: Continous positive airway pressure | |
| Intra oral device treatment | Hypertensive OSA patients treated with IOD Receives: Device: Continous positive airway pressure | |
| Untreated OSA hypertensive patients | Hypertensive OSA patients not using PAP or IOD | |
| Hypertensive patients without OSA | Control population from QregPV without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular event (MCE) or death
First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all)
Measured: First incidence during study, ie within 156 months (13 yrs) maximum
Secondary outcomes (2)
Blood pressure control
According to ESC/EHC 2018 guidelines
Measured: at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum
New incidence of atrial fibrillation
New diagnosis from patient registry
Measured: First incidence during study, ie within 156 months (13yrs) maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study startJan 2008
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 14 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sven Svedmyr, Vastra Gotaland Region
- Investigators
- Sven Svedmyr, MD, Principal investigator, Vastra Gotalands regionen, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115994
- Sponsor's protocol ID
- AHPAP-MCE/death
- Acronym
- AHPAP
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2021
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svedmyr S, Hedner J, Zou D, Parati G, Ryan S, Hein H, Pepin JL, Tkacova R, Marrone O, Schiza S, Basoglu OK, Grote L; European Sleep Apnea Database (ESADA) study group. Superior hypertension control with betablockade in the European Sleep Apnea Database. J Hypertens. 2021 Feb 1;39(2):292-301. doi: 10.1097/HJH.0000000000002629.
PubMed 33031170
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antihypertensive and PAP Treatment in Obstructive Sleep Apnea Patients With Hypertension -Long Term Prospective Analysis on Cardiovascular Events or Death (AHPAP-MCE/Death)
- ClinicalTrials.gov ID
- NCT05115994
- Acronym / sponsor ID
- AHPAP / AHPAP-MCE/death
- Conditions
- Obstructive Sleep Apnea, Hypertension, Death, Cardiac, Treatment Compliance, Heart Failure, Stroke
- Keywords
- Continous positive airway pressure, Antihypertensive treatment, Risc prevention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Jan 2008 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2021 (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.
The investigators will perform a long term registry based prospective analysis on incidence of major cardiovascular events or death in hypertensive patients with obstructive sleep apnea .
Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.
Detailed description
By using swedish personal ID numbers the investigators can combine data from several quality registries in Sweden and will start with patients from a primary care registry (QregPV) that had or received a hypertension diagnosis during the period 2008-2012. The investigators will compare those who got an OSA diagnosis in the SESAR (Swedish sleep apnea registry) stratified by high/low PAP compliance with an intraoral device group, a non treated OSA group as well as a control group without OSA until 2021. Main outcome variables will be major cardiovascular events or death. Outcome data will be collected from the National Patient Registry and Cause of death registry.
Groups will be matched by propensity score for known confounders. Secondary analysis will consider modifying effect of different antihypertensive drugs (the Swedish Prescribed Drug Register, type of therapy; DDD comparison) and the actual degree of hypertension control (blood pressure levels) on CV risk. It is intended to stratify the analysis for BP levels in order to evaluate if lower BP targets further reduce CV risk in hypertensive OSA patients. These analyses will likely be reported in separate publications.
HYPOTHESIS
- PAP treatment in hypertensive OSA patients reduces the long term risk of major cardiovascular events (MCE) and premature death. The risk reduction is modified by PAP compliance, hypertension control and OSA severity.
- In hypertensive OSA patients, the investigators previously identified betablockade as a drug class leading to better pressure control (1). The investigators hypothesize that any risk reduction by PAP treated OSA is influenced by the types of antihypertensive drugs used.
- Lower blood pressure targets (ie better BP control) may reduce the risk of cardiovascular events in PAP treated OSA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hypertensive OSA patients, high PAP compliance | – | Device: Continous positive airway pressureHypertensive OSA patients using their PAP device for at least 4 hrs/night |
| Hypertensive OSA patients, low PAP compliance | – | Device: Continous positive airway pressureHypertensive OSA patients using their PAP device for less than 4 hrs/night |
| Intra oral device treatment | – | Device: Continous positive airway pressureHypertensive OSA patients treated with IOD |
| Untreated OSA hypertensive patients | – | –Hypertensive OSA patients not using PAP or IOD |
| Hypertensive patients without OSA | – | –Control population from QregPV without OSA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Propensity score matched registry cohorts
Key inclusion criteria (1 listed)
- All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.
Key exclusion criteria (4 listed)
- Patients in the hypertensive control group (without OSA) will be excluded if they have OSA diagnosis but are not present in the SESAR registry.
- Subjects with missing data on any of the variables in the fitted model unless the missing data can be accurately imputated.
- Patients with low life expectancy (Age>75 at study start, malignant disease).
- Patients no longer living in VGR 2021.
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 |
|---|---|---|
| Continous positive airway pressureAlso: Antihypertensive pharmacological treatment | Device | Hypertensive OSA patients, high PAP compliance, Hypertensive OSA patients, low PAP compliance, Intra oral device treatment |
Primary outcome
Major cardiovascular event (MCE) or death
Time frame: First incidence during study, ie within 156 months (13 yrs) maximum
First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all)
2 secondary outcomes
Blood pressure control
Time frame: at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum
New incidence of atrial fibrillation
Time frame: First incidence during study, ie within 156 months (13yrs) maximum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 33031170Svedmyr S, Hedner J, Zou D, Parati G, Ryan S, Hein H, Pepin JL, Tkacova R, Marrone O, Schiza S, Basoglu OK, Grote L; European Sleep Apnea Database (ESADA) study group. Superior hypertension control with betablockade in the European Sleep Apnea Database. J Hypertens. 2021 Feb 1;39(2):292-301. doi: 10.1097/HJH.0000000000002629.
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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.
Sven Svedmyr, MD principal investigator
Vastra Gotalands regionen, Sahlgrenska University Hospital
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 Obstructive Sleep Apnea and Hypertension, run by Vastra Gotaland Region at 1 site in Sweden.
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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Major cardiovascular event (MCE) or death (time frame: First incidence during study, ie within 156 months (13 yrs) maximum). 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 NCT05115994, which also lists 1 linked publication.
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 30 Dec 2025.