The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial (MEDOSAHS)
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.
Obstructive Sleep Apnoea
Behavioral: Prudent diet group
Behavioral: Mediterranean diet group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- OSAS severity [ Designated as safety issue: No ]The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.
- AHI during REM sleep and lipid peroxidation marker TBARS [ Designated as safety issue: No ]
- Anthropometric measurements [ Designated as safety issue: No ]weight, height, waist circumference and neck circumference
|Study Start Date:||November 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Prudent diet group
Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.
|Behavioral: Prudent diet group|
Experimental: Mediterranean diet group
Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.
|Behavioral: Mediterranean diet group|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312558
|University of Crete|
|Heraklion, Greece, 2208|