CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea

Phase 4

Recruiting

• Conditions: Sleep Apnea; Dyslipidemias; Hyperuricemia
• Interventions: Other: Hygienic-dietary recommendations and daily physical activity promotion; Device: Continuous positive airway pressure

• Registration Number: NCT06463561
• Lead Sponsor: Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-14
• Study First Posted: 2024-06-18
• Last Update Submitted: 2024-07-11
• Study Start: 2024-07-12
• Last Update Posted: 2024-07-15
• Primary Completion: 2027-07-30
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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 .

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hygienic-dietary recommendations and daily physical activity promotion	Conventional hygienic-dietary recommendations and promotion of daily physical activity
CPAP group	Hygienic-dietary recommendations and daily physical activity promotion	Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)
CPAP group	Continuous positive airway pressure	Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)

Primary Outcome Measures

Name	Time	Method
CPAP effect on lipid profile-4	12 months	Comparison of 12-months change from baseline in the plasma level of triglycerides between the two study groups
CPAP effect on lipid profile	12 months	Comparison of 12-months change from baseline in the plasma level of LDL-cholesterol between the two study groups
CPAP effect on lipid profile-2	12 months	Comparison of 12-months change from baseline in the plasma level of HDL-cholesterol between the two study groups
CPAP effect on lipid profile-3	12 months	Comparison of 12-months change from baseline in the plasma level of total cholesterol between the two study groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario del Henares; 🇪🇸 Coslada, Madrid, Spain