Actively Recruiting
Effect of 12 Months of Continuous Positive Airway Pressure Treatment on Lipid Profile and Hyperuricemia in Patients with Dyslipidemia and Moderate-Severe Obstructive Sleep Apnea
Led by Hospital Universitario La Paz · Updated on 2024-07-15
220
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario La Paz
Lead Sponsor
H
Hospital Universitario del Henares
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of 12 months of continuous positive airway pressure (CPAP) treatment combined with conventional pharmacological therapy on lipid profiles in patients with dyslipidemia and moderate to severe obstructive sleep apnea (OSA). This phase IV randomized, open-label, parallel clinical trial aims to explore improvements in blood lipid levels, serum uric acid, insulin resistance, cardiovascular risk, glycemic control, inflammation markers, and quality of life in this patient group aged 35 to 80 years. Participants will be randomly assigned to one of two groups: one receiving standard hygienic-dietary advice and promotion of daily physical activity, and the other receiving the same plus CPAP therapy. CPAP treatment starts with an empirical pressure of 8 cmH2O and is adjusted within three weeks via automatic titration to a pressure corresponding to the 95th percentile. Patients in both groups will be encouraged to walk 10,000 steps daily, monitored with pedometers and step logs. During the 12-month study, patients will undergo assessments including blood tests for cholesterol, triglycerides, glucose, inflammatory and oxidative stress markers, and hormones related to appetite. Questionnaires on sleepiness, quality of life, and physical activity will also be completed. CPAP compliance, adverse events, and cardiovascular events will be monitored to evaluate safety and treatment effects over the study period ending in January 2028.
CONDITIONS
Brief Title
CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 35 to 80 years
- Diagnosis of dyslipidemia confirmed by clinical records, treatment, or recent blood tests with specific cholesterol and triglyceride levels
- Moderate to severe obstructive sleep apnea with apnea-hypopnea index greater than 15 per hour
You will not qualify if you...
- Predominance of central apneas accounting for more than 25% of total respiratory events
- Indications for CPAP treatment such as hypertension, excessive daytime sleepiness (Epworth Sleepiness Scale > 11), or impaired sleep-related quality of life
- Professional drivers, at-risk professions, or respiratory insufficiency
- Previous treatment with CPAP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants assigned to the CPAP group receive treatment with continuous positive airway pressure starting with an empirical pressure and adjusted within 3 weeks. Participants in both groups receive hygienic-dietary recommendations and support to promote daily physical activity.
Regular visits to monitor CPAP use and physical activity
Trial Site Locations
Total: 1 location
1
Hospital Universitario del Henares
Coslada, Madrid, Spain, 28822
Actively Recruiting
Research Team
F
Francisco Garcia-Rio, MD
F
Francisco Garcia-Rio
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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