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

NCT ID: NCT06463561

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2028-01-31

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.

Conditions

Sleep Apnea; Dyslipidemias; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Conventional hygienic-dietary recommendations and promotion of daily physical activity

Group Type: ACTIVE_COMPARATOR

Hygienic-dietary recommendations and daily physical activity promotion

Intervention Type: OTHER

Hygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.

CPAP group

Conventional hygienic-dietary recommendations and promotion of daily physical activity, plus treatment with positive airway pressure (CPAP)

Group Type: EXPERIMENTAL

Continuous positive airway pressure

Intervention Type: DEVICE

Treatment will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile.

Hygienic-dietary recommendations and daily physical activity promotion

Intervention Type: OTHER

Hygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.

Interventions

Continuous positive airway pressure

Treatment will start with an empirical pressure of 8 cmH2O and, within a maximum of 3 weeks, the pressure will be adjusted by means of automatic titration, establishing the pressure corresponding to the 95th percentile.

Intervention Type: DEVICE

Hygienic-dietary recommendations and daily physical activity promotion

Hygienic-dietary recommendations on sleep and intervention for the promotion of daily physical activity, establishing walking as a goal 10,000 steps per day. To do this, they will be provided with a pedometer and asked to fill out a form with the steps walked each day. At each visit, the distance walked will be reviewed and the goal set will be reiterated.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario del Henares

UNKNOWN

Sponsor Role: collaborator

Hospital Universitario La Paz

OTHER

Sponsor Role: lead

Responsible Party

Francisco Garcia-Rio

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Angeles Ruiz-Cobos, MD

Role: STUDY_CHAIR

Hospital Universitario del Henares

Ana De la Rocha Prieto, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario del Henares

Julia Dorta Díez de la Lastra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario del Henares

Raquel Casitas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Marina Blanco Cruz, ND

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario del Henares

Locations

Hospital Universitario del Henares

Coslada, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Francisco Garcia-Rio, MD

Role: CONTACT

fgr01m@gmail.com

+34639911718

Francisco Garcia-Rio

Role: CONTACT

fgr01m@gmail.com

+34639911718

Facility Contacts

Angeles Ruiz-Cobos, MD

Role: primary

Other Identifiers

082024

Identifier Type: -

Identifier Source: org_study_id