NCT05115994

Brief 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 . Effects of PAP (positive airway pressure) compliance, antihypertensive medication and blood pressure control will be investigated in the study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jan 2008Dec 2026

Study Start

First participant enrolled

January 1, 2008

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

18.4 years

First QC Date

October 7, 2021

Last Update Submit

December 29, 2025

Conditions

Death, CardiacTreatment ComplianceHeart FailureObstructive Sleep ApneaHypertensionStroke

Keywords

Continous positive airway pressureAntihypertensive treatmentRisc prevention

Outcome Measures

Primary Outcomes (1)

  • Major cardiovascular event (MCE) or death

    First incidence of new myocardial infarction, cardiac failure, stroke or death (cardiovascular and all)

    First incidence during study, ie within 156 months (13 yrs) maximum

Secondary Outcomes (2)

  • Blood pressure control

    at study end (latest available BP measurements up to december 2021), ie within 156 months (13 yrs) maximum

  • New incidence of atrial fibrillation

    First incidence during study, ie within 156 months (13yrs) maximum

Other Outcomes (1)

  • Subanalysis of MCE/death incidence, stratified by blood pressure levels

    First incidence during study, ie within 156 months (13yrs) maximum

Study Arms (5)

Hypertensive OSA patients, high PAP compliance

Hypertensive OSA patients using their PAP device for at least 4 hrs/night

Device: Continous positive airway pressure

Hypertensive OSA patients, low PAP compliance

Hypertensive OSA patients using their PAP device for less than 4 hrs/night

Device: Continous positive airway pressure

Intra oral device treatment

Hypertensive OSA patients treated with IOD

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

Interventions

Continous positive airway pressureDEVICE
Also known as: Antihypertensive pharmacological treatment
Hypertensive OSA patients, high PAP complianceHypertensive OSA patients, low PAP complianceIntra oral device treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Propensity score matched registry cohorts

You may qualify if:

  • All hypertensive and obstructive sleep apnea patients present in QregPV and SESAR 2008-2021.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 33031170BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertensionDeathPatient ComplianceHeart FailureStroke

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHeart DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Sven Svedmyr, MD

    Vastra Gotalands regionen, Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, MD Sahlgrenska University Hospital, PhD student Gothenburg University, Specialist internal medicine

Study Record Dates

First Submitted

October 7, 2021

First Posted

November 10, 2021

Study Start

January 1, 2008

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations

SE(1)