CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
NCT Number: NCT06463561
Acronym: CPAPLIP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sleep Apnea|Dyslipidemias|Hyperuricemia
Interventions: DEVICE: Continuous positive airway pressure|OTHER: Hygienic-dietary recommendations and daily physical activity promotion
Sponsor: Hospital Universitario La Paz
Collaborators: Hospital Universitario del Henares
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 220
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2028-01-31
Locations: Hospital Universitario del Henares, Coslada, Madrid, 28822, Spain

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.

Primary Outcome Measures: CPAP effect on lipid profile, Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups, 12 months|CPAP effect on lipid profile-2, Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups, 12 months|CPAP effect on lipid profile-3, Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups, 12 months|CPAP effect on lipid profile-4, Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups, 12 months
Secondary Outcome Measures: CPAP effect on uric acid, Comparison of 12-months change from baseline in the plasma level of uric acid between the two study groups, 12 months|Medium-term CPAP effect on insulin resistance, Comparison of 6-months change from baseline in the HOMA index between the two study groups, 6 months|Long-term CPAP effect on insulin resistance, Comparison of 12-months change from baseline in the HOMA index between the two study groups, 12 months|CPAP effect on cardiovascular risk, Comparison of 12-months change from baseline in the cardiovascular risk score between the two study groups, 12 months|CPAP effect on glycemic control, Comparison of 12-months change from baseline in the plasma level of HbA1c between the two study groups, 12 months|CPAP effect on C-reactive protein, Comparison of 12-months change from baseline in the plasma level of C-reactive protein between the two study groups, 12 months|CPAP effect on sleepiness, Comparison of 12-months change from baseline in the Epworth sleepiness scale between the two study groups, 12 months|CPAP effect on health-related quality of life, Comparison of 12-months change from baseline in the EuroQoL score between the two study groups, 12 months|CPAP effect on health-related quality of life-2, Comparison of 12-months change from baseline in the SF-12 score between the two study groups, 12 months|CPAP effect on daily physical activity, Comparison of 12-months change from baseline in the iPAQ score between the two study groups, 12 months|CPAP effect on inflammatory cytokines, Comparison of 12-months change from baseline in the plasma levels of IL-6, IL-8 and TNF-α between the two study groups, 12 months|CPAP effect on oxidative stress biomarkers, Comparison of 12-months change from baseline in the plasma level of 8-isoprostane between the two study groups, 12 months|CPAP effect on sympathetic tone, Comparison of 12-months change from baseline in the plasma level of neuropeptide Y between the two study groups, 12 months|CPAP effect on intake-regulating hormones, Comparison of 12-months change from baseline in the plasma levels of leptin, orexin A/hypocretin 1 and ghrelin between the two study groups, 12 months