The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
MEDOSAHS
1 other identifier
interventional
40
1 country
1
Brief Summary
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedFebruary 27, 2014
February 1, 2014
1.4 years
March 7, 2011
February 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OSAS severity
The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.
Secondary Outcomes (1)
AHI during REM sleep and lipid peroxidation marker TBARS
Other Outcomes (1)
Anthropometric measurements
Study Arms (2)
Prudent diet group
EXPERIMENTALParticipants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.
Mediterranean diet group
EXPERIMENTALParticipants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with apnoea-hypopnoea index \>15/h and Epworth Sleepiness Scale \> 10
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Crete
Heraklion, 2208, Greece
Related Publications (3)
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.
PMID: 26015461DERIVEDPapandreou 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.
PMID: 22034645DERIVEDPapandreou 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.
PMID: 21918812DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Christopher Papandreou
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 10, 2011
Study Start
November 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 27, 2014
Record last verified: 2014-02