Effects of CPAP on cholesterol and uric acid levels in patients with sleep apnea and high cholesterol
Effect of 12 Months of Treatment With Continuous Positive Airway Pressure on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea. A Randomized, Open-labell, Parallel Clinical Trial
This study tests if using a CPAP machine for a year can help people with sleep apnea and high cholesterol lower their cholesterol and uric acid levels while also improving their overall health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Coslada, Madrid) |
| Trial ID | NCT06463561 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of 12 months of continuous positive airway pressure (CPAP) treatment combined with standard pharmacological therapy on the lipid profiles and serum uric acid levels in patients suffering from moderate to severe obstructive sleep apnea and dyslipidemia. The study aims to assess not only improvements in lipid profiles but also the effects on insulin resistance, cardiovascular risk, glycemic control, and inflammation markers. Participants will receive hygienic-dietary recommendations and be encouraged to engage in daily physical activity as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35 to 80 with a diagnosis of dyslipidemia and moderate to severe obstructive sleep apnea.
Not a fit: Patients with central sleep apnea or those already indicated for CPAP treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of lipid levels and reduced cardiovascular risks for patients with sleep apnea and dyslipidemia.
How similar studies have performed: Previous studies have shown promising results in improving health outcomes with CPAP treatment in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects from 35 to 80 years old * Diagnosis of dyslipidemia. It will be considered as such, the existence of a previous clinical record of a diagnosis of dyslipidemia associated with treatment with lipidlowering agents, treatment with lipid-lowering agents or the presence of an altered blood test in the last two months, using the following cut-off points: total cholesterol ≥ 200 mg/dl, triglycerides ≥ 180 mg/dl, HDL-cholesterol ≤ 40 mg/dl or LDL-cholesterol ≥ 150 mg/dl. * Moderate-severe sleep apnea, defined by AHI \> 15 h-1 . Exclusion Criteria: * Predominance of central apneas-hypopneas, defined as more than 25% of total respiratory events. * Patients with indications for CPAP treatment according to the International Sleep Consensus: hypertensive, excessive daytime sleepiness (Epworth Sleepiness Scale \> 11) or impaired sleep-related quality of life considered relevant by their regular physician. * Professional drivers, at-risk profession or respiratory insufficiency (according to criteria of the clinical pathway for the diagnosis and treatment of sleep-disordered breathing). * Pretreatment with CPAP
Where this trial is running
Coslada, Madrid
- Hospital Universitario del Henares — Coslada, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Ana De la Rocha Prieto, MD — Hospital Universitario del Henares
- Study coordinator: Francisco Garcia-Rio, MD
- Email: fgr01m@gmail.com
- Phone: +34639911718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.