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

Obstructive Sleep Apnoea Clinical Trial

— MEDOSAHS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312558
• Other study ID #: NCT01312558
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: February 26, 2014
• Start date: November 2008
• Est. completion date: April 2010

Study information

• Verified date: February 2014
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypopnoea Syndrome
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Prudent diet group

• Mediterranean diet group

Locations

Country	Name	City	State
Greece	University of Crete	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometric measurements	weight, height, waist circumference and neck circumference		No
Primary	OSAS severity	The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.		No
Secondary	AHI during REM sleep and lipid peroxidation marker TBARS			No