Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463561
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-12
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:
Hospital Universitario La Paz
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 11 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 Ahypocretin 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 11 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 Ahypocretin 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:
None
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?:
None