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

Primary Purpose

Obstructive Sleep Apnoea, Hypopnoea Syndrome

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Prudent diet group
Mediterranean diet group
Sponsored by
University of Crete
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnoea focused on measuring obstructive sleep apnoea/hypopnoea syndrome, Mediterranean diet, exercise, weight loss, continuous positive airway pressure, lipid peroxidation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Crete

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prudent diet group

Mediterranean diet group

Arm Description

Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.

Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.

Outcomes

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

Full Information

First Posted
March 7, 2011
Last Updated
February 26, 2014
Sponsor
University of Crete
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1. Study Identification

Unique Protocol Identification Number
NCT01312558
Brief Title
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
Acronym
MEDOSAHS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea, Hypopnoea Syndrome
Keywords
obstructive sleep apnoea/hypopnoea syndrome, Mediterranean diet, exercise, weight loss, continuous positive airway pressure, lipid peroxidation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prudent diet group
Arm Type
Experimental
Arm Description
Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.
Arm Title
Mediterranean diet group
Arm Type
Experimental
Arm Description
Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Prudent diet group
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet group
Primary Outcome Measure Information:
Title
OSAS severity
Description
The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.
Secondary Outcome Measure Information:
Title
AHI during REM sleep and lipid peroxidation marker TBARS
Other Pre-specified Outcome Measures:
Title
Anthropometric measurements
Description
weight, height, waist circumference and neck circumference

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Crete
City
Heraklion
ZIP/Postal Code
2208
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
26015461
Citation
Papandreou C, Hatzis CM, Fragkiadakis GA. Effects of different weight loss percentages on moderate to severe obstructive sleep apnoea syndrome. Chron Respir Dis. 2015 Aug;12(3):276-8. doi: 10.1177/1479972315587516. Epub 2015 May 25. No abstract available.
Results Reference
derived
PubMed Identifier
22034645
Citation
Papandreou C, Schiza SE, Bouloukaki I, Hatzis CM, Kafatos AG, Siafakas NM, Tzanakis NE. Effect of Mediterranean diet versus prudent diet combined with physical activity on OSAS: a randomised trial. Eur Respir J. 2012 Jun;39(6):1398-404. doi: 10.1183/09031936.00103411. Epub 2011 Oct 27.
Results Reference
derived
PubMed Identifier
21918812
Citation
Papandreou C, Schiza SE, Tzatzarakis MN, Kavalakis M, Hatzis CM, Tsatsakis AM, Kafatos AG, Siafakas NM, Tzanakis NE. Effect of Mediterranean diet on lipid peroxidation marker TBARS in obese patients with OSAHS under CPAP treatment: a randomised trial. Sleep Breath. 2012 Sep;16(3):873-9. doi: 10.1007/s11325-011-0589-7. Epub 2011 Sep 15.
Results Reference
derived

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

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