Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 10:01 PM
Study NCT ID:
NCT06463561
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea
Sponsor:
Hospital Universitario La Paz
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CPAPLIP
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: