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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01312558
Acronym
MEDOSAHS
Enrollment
40
Registered
2011-03-10
Start date
2008-11-30
Completion date
2010-04-30
Last updated
2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopnoea Syndrome, Obstructive Sleep Apnoea

Keywords

obstructive sleep apnoea/hypopnoea syndrome, Mediterranean diet, exercise, weight loss, continuous positive airway pressure, lipid peroxidation

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.

Interventions

BEHAVIORALPrudent diet group

Sponsors

University of Crete
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
OSAS severityThe primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.

Secondary

MeasureTime frame
AHI during REM sleep and lipid peroxidation marker TBARS

Other

MeasureTime frameDescription
Anthropometric measurementsweight, height, waist circumference and neck circumference

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026