The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnoea Hypopnea Syndrome |
Behavioral: Prudent diet group Behavioral: Mediterranean diet group |
| Study Type: | Interventional |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
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
- Therapy with sleeping pills
- Use of anti-depressive medication
- BMI < 30.0 Kg/m2
Contacts and Locations
More Information
No publications provided by University of Crete
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT01312558 History of Changes |
| Other Study ID Numbers: | MEDOSAHS |
| Study First Received: | March 7, 2011 |
| Last Updated: | March 9, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Crete:
|
obstructive sleep apnoea/hypopnoea syndrome Mediterranean diet exercise |
weight loss continuous positive airway pressure lipid peroxidation |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013