Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

Summary

OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA).

Secondary objectives:

* Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA.
* Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA.

DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment.

STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels\> 100 mg / dl in the last two successive visits clinics.

Sample size. 38 patients who completed the test in each treatment arm.

TREATMENT

Patients will be randomized to one of the following treatment arms form:

1. hygiene and dietary recommendations.
2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
3. Treatment with positive airway pressure (CPAP).

ENDPOINTS:

Efficacy endpoints.

* Primary endpoint: LDL-cholesterol.
* Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP).
* Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin).
* Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH).
* Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ).

Security endpoints.

* Notification of clinical adverse events.
* Compliance with CPAP (average hours use per day).
* Epworth Sleepiness Questionnaire.
* Development of cardiovascular events.

Conditions

• Sleep Apnea
• Dyslipidaemia

Interventions

DEVICE

Continuous positive airway pressure

Treatment with nasal CPAP. Treatment begins with an empirical pressure of 8 cmH2O and in a period of three weeks, the pressure is adjusted by automatic titration with AutoSet II (ResMed) device.

BEHAVIORAL

Intensive lifestyle intervention

Specific alimentary plan (carbohydrates: 40-45%; fats: 25-35% \[saturated fats \<7% monounsaturated fats up to 20% and polyunsaturated fats \<10% \] and proteins: 15-20%) and recommendation to increase daily physical activity, setting a target walking 10,000 steps a day. The patients will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked.

OTHER

Conventional treatment

Hygiene and diet recommendations on sleep

Sponsors & Collaborators

• Hospital Universitario Principe de Asturias

  collaborator OTHER

• Hospital Universitario La Paz

  lead OTHER

Principal Investigators

• Francisco Garcia-Rio, MD · Hospital Universitario La Paz, IdiPAZ

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Spain

Study Locations