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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Papandreou, University of Crete
ClinicalTrials.gov Identifier:
NCT01312558
First received: March 7, 2011
Last updated: February 26, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Crete:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • AHI during REM sleep and lipid peroxidation marker TBARS [ Designated as safety issue: No ]

Other Outcome Measures:
  • Anthropometric measurements [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312558

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

No publications provided by University of Crete

Additional 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
Other Study ID Numbers: NCT01312558
Study First Received: March 7, 2011
Last Updated: February 26, 2014
Health Authority: Greece: Ethics Committee

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 August 28, 2014