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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312558
First Posted: March 10, 2011
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Papandreou, University of Crete
  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 Hypopnoea Syndrome Behavioral: Prudent diet group Behavioral: Mediterranean diet group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Christopher Papandreou, University of Crete:

Primary Outcome Measures:
  • OSAS severity
    The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.


Secondary Outcome Measures:
  • AHI during REM sleep and lipid peroxidation marker TBARS

Other Outcome Measures:
  • Anthropometric measurements
    weight, height, waist circumference and neck circumference


Enrollment: 40
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312558


Locations
Greece
University of Crete
Heraklion, Greece, 2208
Sponsors and Collaborators
University of Crete
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Papandreou, University of Crete
ClinicalTrials.gov Identifier: NCT01312558     History of Changes
First Submitted: March 7, 2011
First Posted: March 10, 2011
Last Update Posted: February 27, 2014
Last Verified: February 2014

Keywords provided by Christopher Papandreou, University of Crete:
obstructive sleep apnoea/hypopnoea syndrome
Mediterranean diet
exercise
weight loss
continuous positive airway pressure
lipid peroxidation

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases


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