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

NCT06930989 | Completed

• 1 other identifier: SERA Lund DNR:2025-00712-02
• Study Type: observational
• Target: 148,467
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; OSA - Obstructive Sleep Apnea; MACE; Survival Analysis; PAP

Keywords

Primary CV prevention; hypertension; OSA; PAP

Outcome Measures

Primary Outcomes (3)

• Major cardiovascular event (MACE)

  Major cardiovascular event (MACE) including CV death

  First event during follow-up 2010-2022

• Age at first MACE

  mean age at first MACE for the groups

  First event during follow-up 2010-2022

• All cause death

  death from any cause during follow-up

  2010-2022

Secondary Outcomes (1)

• Risk reduction with PAP

  2010-2022

Study Arms (4)

Hypertension and obstructive sleep apnea (OSA)

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

Device: Positive airway pressure (PAP)

OSA alone

Patients with PAP teated OSA but no hypertension

Device: Positive airway pressure (PAP)

Hypertension control

Patients of control population with hypertension

Healthy controls

Control population without hypertension and without OSA

Interventions

Positive airway pressure (PAP) DEVICE

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

Hypertension and obstructive sleep apnea (OSA); OSA alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Discovery ("Course of DISease in patients reported to the Swedish CPAP Oxygen and VEntilator RegistrY") 2.0 is a large clinical cohort on patients with home mechanical ventilation, long-term oxygen treatment and/or CPAP treatment with data from the Swedish national register for patients on Long Term Oxygen Therapy and Home Mechanical Ventilation (Swedevox) and the Swedish Sleep Apnea Registry (SESAR). Data are cross referenced using Swedish personal IDs with data from multiple Swedish national registries including the National Patients diagnosis registry, National prescription registry, National Cause of Death Register, and SCBs registries on socioeconomic information. All patients starting PAP treatment for OSA during 2010-2021 are included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Swedish Heart Lung Foundation: collaborator
• Göteborg University: collaborator
• Lund University: collaborator
• Uppsala University: collaborator

Study Sites (1)

Sahlgrenska University Hospital and Göteborg University

Gothenburg, VGR, 41390, Sweden

Location

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sven Svedmyr, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: January 1, 2025
• Primary Completion: April 8, 2025
• Study Completion: April 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: SAP will be public here. Original data is property of the Discovery registry, see above.
• Access Criteria: SAP here. Data see above.

Locations

SE (1)