Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea

Summary

Obstructive sleep apnea (OSA) is a sleep disorder characterized by recurrent episodes of partial or complete collapse of the upper airway during sleep, leading to pauses of breathing and arousals. Although previously considered as a local abnormality of the respiratory track, it is nowadays recognized as a systemic disease and an important cause of morbidity and mortality, since it is strongly associated with obesity (especially abdominal obesity) and cardiometabolic diseases, including cardiovascular diseases and diabetes mellitus. Interestingly, recent hypotheses support that the metabolic syndrome pathology, including insulin resistance, inflammation and oxidative stress may be involved in OSA pathogenesis. The modification of lifestyle habits, e.g. in terms of diet and physical activity, is currently explored as a mean of managing the disease in combination with the first line treatment, i.e., the application of continuous positive airway pressure (CPAP) during sleep. The available data support that weight loss, achieved through lifestyle modification, effectively reduces the severity of OSA and improves the associated cardiometabolic disorders in overweight or obese patients. However, studies exploring the potential effect of diet's quality or other lifestyle habits (such as physical activity) on OSA severity, besides weight loss, are currently lacking. Given that a Mediterranean dietary pattern, as well as other lifestyle habits adopted by the populations in the Mediterranean region, have been proven beneficial both for the prevention and the resolution of the metabolic syndrome and its associated cardiometabolic diseases, the aim of the present randomized, controlled, single-blind study is to implement an intensive intervention based on the Mediterranean lifestyle (hypocaloric diet and 7 group lifestyle counselling sessions) and to evaluate its potential benefits, compared with standard care (hypocaloric diet and written advice for healthy lifestyle), in a sample of patients with OSA.

Conditions

• Obstructive Sleep Apnea

Interventions

BEHAVIORAL

Mediterranean lifestyle

Comprehensive 6-month lifestyle intervention (7 60-min group counselling sessions) aiming at promoting adherence to the Mediterranean lifestyle (food and food group consumption according to the Mediterranean diet, beneficial culinary practices, seasonality and locality of foods consumed, socialization during meals, adequate rest during the day through night sleep and siesta nap, sleep hygiene recommendations and adoption of a physically active lifestyle) and at achieving a 5-10% weight loss.

BEHAVIORAL

Standard care

General written instructions regarding the adoption of a healthy lifestyle.

BEHAVIORAL

Mediterranean diet

Comprehensive 6-month lifestyle intervention (7 60-min group counselling sessions) aiming at promoting adherence to the Mediterranean dietary pattern (food and food group consumption according to the Mediterranean diet, beneficial culinary practices and seasonality and locality of foods consumed) and at achieving a 5-10% weight loss.

Sponsors & Collaborators

• National and Kapodistrian University of Athens

  collaborator OTHER

• Harokopio University

  lead OTHER

Principal Investigators

• Meropi D Kontogianni, PhD · Harokopio University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-07

Primary Completion

2020-01-10

Completion

2020-01-10

Countries

• Greece

Study Locations