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

NCT02557412 | Withdrawn

• 1 other identifier: PINML01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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:
• hygiene and dietary recommendations.
• lifestyle intervention (more strict and promotion of daily physical activity and dietary control).
• Treatment with positive airway pressure (CPAP).
• 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

Outcome Measures

Primary Outcomes (1)

• LDL-cholesterol

  LDL-cholesterol level in peripheral blood

  6 months

Secondary Outcomes (9)

• Lipid profile

  6 months

• Systemic biomarkers

  6 months

• Glycated hemoglobin

  6 months

• Insulin resistance

  6 months

• Health-related quality of life

  6 months

Study Arms (3)

Conventional treatment

PLACEBO COMPARATOR

Hygiene and diet recommendations on sleep.

Other: Conventional treatment

Intensive lifestyle intervention

ACTIVE COMPARATOR

Lifestyle intervention will consist of a structured intervention in a 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%), which will be repeated in each review. Also, be recommended to increase daily physical activity, setting a target walking 10,000 steps a day. To do this, to patients assigned to this treatment arm, 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.

Behavioral: Intensive lifestyle intervention

Continuous positive airway pressure

ACTIVE COMPARATOR

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

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure DEVICE

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.

Continuous positive airway pressure

Intensive lifestyle intervention BEHAVIORAL

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.

Intensive lifestyle intervention

Conventional treatment OTHER

Hygiene and diet recommendations on sleep

Conventional treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of dyslipidemia: The existence of a previous clinical diagnostic of dyslipidemia associated with lipid-lowering therapy. It is also considered patients who have an altered analytical, using the following cutoffs: total cholesterol ≥ 200 mg / dl, triglycerides ≥ 180 mg / dl, HDL-cholesterol ≤ 40 mg / dl or LDL-cholesterol ≥ 150 mg / dl. Lipid-lowering treatment and diet, stable in the last month.
• An apnea-hypopnea index between 5-30 h-1

You may not qualify if:

• Apnea-hypopnea index of less than 5 h-1 or greater than 30 h-1.
• Predominance of central apneas and hypopneas, defined as more than 25% of all respiratory events.
• Professional drivers, risk profession or respiratory failure (according to criteria of the clinical pathway for diagnosis and treatment of sleep-disordered breathing).
• Very excessive daytime sleepiness (Epworth Sleepiness Scale\> 18).
• Morbid obesity (BMI\> 40 kg / m2).
• Prior treatment with CPAP.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• Hospital Universitario Principe de Asturias: collaborator

Study Sites (1)

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Dyslipidemias

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Francisco Garcia-Rio, MD

  Hospital Universitario La Paz, IdiPAZ

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: September 23, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

ES (1)