The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial

Not Applicable

Completed

• Conditions: Hypopnoea Syndrome; Obstructive Sleep Apnoea
• Interventions: Behavioral: Prudent diet group; Behavioral: Mediterranean diet group

• Registration Number: NCT01312558
• Lead Sponsor: University of Crete

Brief Summary

This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.

Detailed Description

Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is considered to be one of the most prevalent sleep-related breathing disorders, with an enormous effect on public health. Approximately 2-4% of the general adult population experiences some degree of this syndrome. This percentage increases even more with obesity, up to 20-40%, especially in individuals with an excessive body mass index (BMI) \> 30 kg/m2. OSAHS is associated with significant systemic consequences, including cardiovascular morbidity and mortality, and the risk increases with the severity of the syndrome. The pathophysiology underlying the link between OSAHS and the cardiovascular system is attributed largely to systemic inflammation and oxidative stress, which are both contributors to endothelial dysfunction. The treatment modalities of OSAHS include continuous positive airway pressure (CPAP), weight loss, upper airway surgery, and medication. CPAP is the first line therapy, as a means of maintaining upper airway patency, and it is well known that this intervention reduces morbidity and mortality. In severe cases of OSAHS the weight loss strategy is essential and must accompany CPAP treatment. A growing body of evidence in OSAHS supports the beneficial role of weight reduction, induced by diet alone or in combination with exercise, leading to a reduction in apnoeas and hypopnoeas.We aim to evaluate the effect of the Mediterranean diet compared with that of a prudent diet on obese OSAHS patients who were treated with CPAP while receiving counselling to increase their physical activity.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with apnoea-hypopnoea index >15/h and Epworth Sleepiness Scale > 10

Exclusion Criteria

• Diseases such as ischaemic heart disease, diabetes mellitus, thyroid disorders, and malignancies
• Upper airway surgery
• Gestation
• Alcoholism
• Diet for weight reduction during the last 6 months
• Eating habits close to the Mediterranean diet at the entry phase
• Intake of antioxidant supplements
• Medications affecting weight
• Smoking (in the case of TBARS)
• Therapy with sleeping pills
• Use of anti-depressive medication
• BMI < 30.0 Kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prudent diet group	Prudent diet group	Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.
Mediterranean diet group	Mediterranean diet group	Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.

Primary Outcome Measures

Name	Time	Method
OSAS severity		The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.

Secondary Outcome Measures

Name	Time	Method
AHI during REM sleep and lipid peroxidation marker TBARS

Trial Locations

Locations (1)

University of Crete; 🇬🇷 Heraklion, Greece