Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea

NCT02515357 | Completed

• 1 other identifier: 46
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep Disorders; Metabolic Syndrome; Mediterranean Diet; Mediterranean Lifestyle

Outcome Measures

Primary Outcomes (1)

• Severity of obstructive sleep apnea

  Reduction in the Apnea Hypopnea Index (AHI)

  6 months

Secondary Outcomes (7)

• Sleep quality

  6 months

• Daytime sleepiness

  6 months

• Physical and mental health

  6 months

• Insulin resistance

  6 months

• Subclinical inflammation

  6 months

Study Arms (3)

Control group

PLACEBO COMPARATOR

This arm will receive standard care, i.e. CPAP prescription and brief written healthy lifestyle advice.

Behavioral: Standard care

Mediterranean lifestyle group

EXPERIMENTAL

This arm will receive a hypocaloric diet and attend a comprehensive 6-month lifestyle intervention based on the Mediterranean lifestyle on top of standard care.

Behavioral: Mediterranean lifestyle

Mediterranean diet group

EXPERIMENTAL

This arm will receive a hypocaloric diet and attend a comprehensive 6-month dietary intervention based on the Mediterranean dietary pattern on top of standard care.

Behavioral: Mediterranean diet

Interventions

Mediterranean lifestyle BEHAVIORAL

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.

Mediterranean lifestyle group

Standard care BEHAVIORAL

General written instructions regarding the adoption of a healthy lifestyle.

Control group

Mediterranean diet BEHAVIORAL

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.

Mediterranean diet group

Eligibility Criteria

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

You may qualify if:

• Presence of obstructive sleep apnea diagnosed through polysomnography
• Presence of overweight or obesity (Body Mass Index \> 25 kg/m2)

You may not qualify if:

• Presence of central sleep apnea
• Presence of other causes of sleep disorders, such as narcolepsy, restless leg syndrome or chronic pain syndrome
• Hospitalization during the last year due to acute or chronic respiratory disease or required use of supplemental oxygen
• Presence of diabetes mellitus
• Presence of cardiovascular disease
• Presence of severe hypertension (blood pressure \> 160/95 mm Hg)
• Presence of neoplasm
• Presence of chronic inflammatory diseases
• Presence of psychiatric disorders, such as major depression, schizophrenia or suicidal ideation
• Pregnancy or breast feeding (for women)
• Surgery during the last three months
• Reception of antipsychotics, antidepressants or other sleep inducing drugs, systematic reception of steroids or hormone replacement therapy for women
• Excessive alcohol consumption (\> 210 or \> 140 gr of alcohol per week for men and women, respectively)
• Adherence to a hypocaloric diet for weight loss or changes in dietary habits during the last six months

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Harokopio University

Kallithea, Attica, 17671, Greece

Location

Related Publications (4)

• Georgoulis M, Yiannakouris N, Kechribari I, Lamprou K, Perraki E, Vagiakis E, Kontogianni MD. Sustained improvements in the cardiometabolic profile of patients with obstructive sleep apnea after a weight-loss Mediterranean diet/lifestyle intervention: 12-month follow-up (6 months post-intervention) of the "MIMOSA" randomized clinical trial. Nutr Metab Cardiovasc Dis. 2023 May;33(5):1019-1028. doi: 10.1016/j.numecd.2023.02.010. Epub 2023 Feb 18.

  PMID: 36958969 DERIVED

• Georgoulis M, Yiannakouris N, Kechribari I, Lamprou K, Perraki E, Vagiakis E, Kontogianni MD. Dose-response relationship between weight loss and improvements in obstructive sleep apnea severity after a diet/lifestyle interventions: secondary analyses of the "MIMOSA" randomized clinical trial. J Clin Sleep Med. 2022 May 1;18(5):1251-1261. doi: 10.5664/jcsm.9834.

  PMID: 34915980 DERIVED

• Georgoulis M, Yiannakouris N, Tenta R, Fragopoulou E, Kechribari I, Lamprou K, Perraki E, Vagiakis E, Kontogianni MD. A weight-loss Mediterranean diet/lifestyle intervention ameliorates inflammation and oxidative stress in patients with obstructive sleep apnea: results of the "MIMOSA" randomized clinical trial. Eur J Nutr. 2021 Oct;60(7):3799-3810. doi: 10.1007/s00394-021-02552-w. Epub 2021 Apr 10.

  PMID: 33839919 DERIVED

• Georgoulis M, Yiannakouris N, Kechribari I, Lamprou K, Perraki E, Vagiakis E, Kontogianni MD. The effectiveness of a weight-loss Mediterranean diet/lifestyle intervention in the management of obstructive sleep apnea: Results of the "MIMOSA" randomized clinical trial. Clin Nutr. 2021 Mar;40(3):850-859. doi: 10.1016/j.clnu.2020.08.037. Epub 2020 Sep 6.

  PMID: 32928580 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Metabolic Syndrome

Interventions

Standard of Care; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Meropi D Kontogianni, PhD

  Harokopio University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Nutrition

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 4, 2015
• Study Start: September 7, 2015
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)