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

Twin Threat of OSA and Hypertension on Mortality/CV-risk and Protective Effect by Positive Airway Pressure Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; OSA - Obstructive Sleep Apnea; MACE; Survival Analysis; PAP
• Intervention / Treatment: Device: Positive airway pressure (PAP)

Detailed Description

Please see attached analysis plan

• Study Type: Observational
• Enrollment (Actual): 148467

Contacts and Locations

Study Locations

• Sweden
  • VGR
    • Göteborg, VGR, Sweden, 41390
      • Sahlgrenska University Hospital and Göteborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertension and obstructive sleep apnea (OSA); Patients with hypertension and positive airway pressure (PAP) treated OSA	Device: Positive airway pressure (PAP); Intervention as part of routine clinical care. Data from national registries.
OSA alone; Patients with PAP teated OSA but no hypertension	Device: Positive airway pressure (PAP); Intervention as part of routine clinical care. Data from national registries.
Hypertension control; Patients of control population with hypertension
Healthy controls; Control population without hypertension and without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk reduction with PAP	Survival analysis between both OSA groups only stratified by PAP adherence (hours/night)	2010-2022

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Collaborators: Lund University; Uppsala University; Göteborg University; Swedish Heart Lung Foundation
• Investigators: Principal Investigator: Sven Svedmyr, MD, Sahlgrenska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): April 8, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: OSA; hypertension; PAP; Primary CV prevention
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Hypertension; Sleep Apnea, Obstructive
• Other Study ID Numbers: SERA Lund DNR:2025-00712-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be made available from the discovery cohort on case to case basis after applying to the discovery cohort registry holder after reasonable request.
• IPD Sharing Time Frame: SAP will be public here. Original data is property of the Discovery registry, see above.
• IPD Sharing Access Criteria: SAP here. Data see above.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No