Primary Prevention Long-term Registry Study in OSA and Hypertension. Survival Analysis 2010-2022

NCT ID: NCT06930989

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-04-30

Brief Summary

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Hypertension and obstructive sleep apnea (OSA) are both common conditions that independently increase the risk cardiovascular disease including atrial fibrillation, ischemic heart disease, heart failure and stroke. OSA is also an independent promoter of hypertension development and poorly controlled hypertension is overrepresented in OSA. Finally, HT and OSA share many risk factors including obesity, and several lifestyle factors. Altogether, these links contribute to a high prevalence of patients with both disorders.

The investigators suspect participants with HT and OSA are at even higher CV risk and may get their first CV event earlier in life. Comparison between HT and OSA participants vs HT alone, OSA alone or healthy controls has not previously been investigated in large studies.

Thus, the investigators aim to investigate long-term risk of major cardiovascular events (MACE) or death comparing these groups in registry data between 2010-2022 in Sweden. The investigators will also investigate the protecting effect of positive airway pressure (PAP) on the OSA related CV risk increase and how many hours/night of PAP use is needed to get any protective effects.

Detailed Description

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Please see attached analysis plan

Conditions

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Hypertension OSA - Obstructive Sleep Apnea MACE Survival Analysis PAP

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypertension and obstructive sleep apnea (OSA)

Patients with hypertension and positive airway pressure (PAP) treated OSA

Positive airway pressure (PAP)

Intervention Type DEVICE

Intervention as part of routine clinical care. Data from national registries.

OSA alone

Patients with PAP teated OSA but no hypertension

Positive airway pressure (PAP)

Intervention Type DEVICE

Intervention as part of routine clinical care. Data from national registries.

Hypertension control

Patients of control population with hypertension

No interventions assigned to this group

Healthy controls

Control population without hypertension and without OSA

No interventions assigned to this group

Interventions

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Positive airway pressure (PAP)

Intervention as part of routine clinical care. Data from national registries.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult patients starting PAP treatment for OSA in the swedevox registry between 2010-2021 with and without hypertension. Randomly selected controls with and without hypertension from the general population.

Exclusion Criteria

* Patients with manifest cardiovascular disease (stroke, ischemic heart disease, cardiac failure or atrial fibrillation at baseline).
* Patients with kidney failure at baseline.
* Patients with malignant cancer at baseline.
* Subjects with missing data on any of the main variables in the fitted models.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Heart Lung Foundation

OTHER

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sven Svedmyr

MD, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Svedmyr, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital and Göteborg University

Gothenburg, VGR, Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SERA Lund DNR:2025-00712-02

Identifier Type: -

Identifier Source: org_study_id

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