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| Name | Class |
|---|---|
| Swedish Heart Lung Foundation | OTHER |
| Göteborg University | OTHER |
| Lund University | OTHER |
| Uppsala University |
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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.
Please see attached analysis plan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertension and obstructive sleep apnea (OSA) | Patients with hypertension and positive airway pressure (PAP) treated OSA |
| |
| OSA alone | Patients with PAP teated OSA but no hypertension |
| |
| Hypertension control | Patients of control population with hypertension | ||
| Healthy controls | Control population without hypertension and without OSA |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive airway pressure (PAP) | Device | Intervention as part of routine clinical care. Data from national registries. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Risk reduction with PAP | Survival analysis between both OSA groups only stratified by PAP adherence (hours/night) | 2010-2022 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sven Svedmyr, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital and Göteborg University | Gothenburg | VGR | 41390 | Sweden |
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.
SAP will be public here. Original data is property of the Discovery registry, see above.
SAP here. Data see above.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2025 | Apr 22, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
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| OTHER |
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| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |