NCT06463561 CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
| NCT ID | NCT06463561 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Universitario La Paz |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-07-12 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 220 participants in total. It began in 2024-07-12 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Clinical Trial Phase IV Indication: Moderate-severe obstructive sleep apnea and dyslipidemia. Objectives: Main objective: To test whether 12 months of CPAP treatment associated with conventional pharmacological treatment improves the lipid profile of patients with dyslipidemia and moderate to severe OSA. Secondary objectives: * To test whether 12 months of treatment with CPAP associated with conventional pharmacological treatment improves serum uric acid concentration in patients with dyslipidemia and moderate-severe OSA. * To determine the additional medium- and long-term effect of CPAP on insulin resistance in patients with dyslipidemia and moderate-severe OSA. * To evaluate the impact of CPAP treatment on cardiovascular risk reduction in patients with dyslipidemia and moderate-severe OSA. * To analyze the impact of supplemental CPAP treatment on glycemic control and C-reactive protein concentration in patients with dyslipidemia and moderate-severe OSA. * To establish the impact of supplemental CPAP therapy on health-related quality of life in patients with dyslipidemia and moderate-severe OSA. * To evaluate the effect of CPAP on inflammatory cytokines, oxidative stress biomarkers, sympathetic tone and intake-regulating hormones in patients with dyslipidemia and moderate-severe OSA. * To relate CPAP-induced changes in serum lipid and uric acid concentration to changes in basal inflammatory response, oxidative stress, sympathetic activity, and intake-regulating hormones. * To identify the subgroup of patients with dyslipidemia and moderate-severe OSA in whom 12 months of CPAP treatment achieves a more marked reduction in serum lipids and uric acid. Design Randomized, parallel-group, nonblinded, controlled clinical trial with conventional treatment. Study population Subjects aged 35 to 80 years with a diagnosis of dyslipidemia made at least six months ago and with moderate-severe obstructive sleep apnea (OSA) not requiring CPAP treatment according to conventional indications. Sample size: 110 patients in each treatment arm. Treatment Patients will be randomly assigned in a 1:1 ratio to one of the following treatment arms: 1. Conventional hygienic-dietary recommendations and promotion of daily physical activity. 2. Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP). Efficiency variables * Main variables: LDL-cholesterol and uric acid. * Total cholesterol, HDL-cholesterol and triglycerides. * Basal blood glucose, glycosylated hemoglobin (HbA1c), creatinine and C-reactive protein. * Systemic biomarkers: inflammatory (IL-6, IL-8 and TNF-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, VCAM-1 and ICAM-1), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A/hypocretin 1 and ghrelin). * Clinical questionnaires: SF-12, EuroQoL, FOSQ and IPAQ. Safety variables * Clinical adverse event reporting. * CPAP compliance (average hours of use per day). * Epworth Sleepiness Questionnaire. * Development of cardiovascular events.
Eligibility 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
Contact & Investigator
Maria Angeles Ruiz-Cobos, MD
STUDY CHAIR
Hospital Universitario del Henares
Frequently Asked Questions
Who can join the NCT06463561 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06463561 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06463561 currently recruiting?
Yes, NCT06463561 is actively recruiting participants. Contact the research team at fgr01m@gmail.com for enrollment information.
Where is the NCT06463561 trial being conducted?
This trial is being conducted at Coslada, Spain.
Who is sponsoring the NCT06463561 clinical trial?
NCT06463561 is sponsored by Hospital Universitario La Paz. The principal investigator is Maria Angeles Ruiz-Cobos, MD at Hospital Universitario del Henares. The trial plans to enroll 220 participants.