Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01312558
Status:
COMPLETED
Last Update Posted:
2014-02-27
First Post:
2011-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-26', 'studyFirstSubmitDate': '2011-03-07', 'studyFirstSubmitQcDate': '2011-03-09', 'lastUpdatePostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anthropometric measurements', 'description': 'weight, height, waist circumference and neck circumference'}], 'primaryOutcomes': [{'measure': 'OSAS severity', 'description': 'The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.'}], 'secondaryOutcomes': [{'measure': 'AHI during REM sleep and lipid peroxidation marker TBARS'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['obstructive sleep apnoea/hypopnoea syndrome', 'Mediterranean diet', 'exercise', 'weight loss', 'continuous positive airway pressure', 'lipid peroxidation'], 'conditions': ['Obstructive Sleep Apnoea', 'Hypopnoea Syndrome']}, 'referencesModule': {'references': [{'pmid': '26015461', 'type': 'DERIVED', '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.'}, {'pmid': '22034645', 'type': 'DERIVED', '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.'}, {'pmid': '21918812', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with apnoea-hypopnoea index \\>15/h and Epworth Sleepiness Scale \\> 10\n\nExclusion Criteria:\n\n* Diseases such as ischaemic heart disease, diabetes mellitus, thyroid disorders, and malignancies\n* Upper airway surgery\n* Gestation\n* Alcoholism\n* Diet for weight reduction during the last 6 months\n* Eating habits close to the Mediterranean diet at the entry phase\n* Intake of antioxidant supplements\n* Medications affecting weight\n* Smoking (in the case of TBARS)\n* Therapy with sleeping pills\n* Use of anti-depressive medication\n* BMI \\< 30.0 Kg/m2'}, 'identificationModule': {'nctId': 'NCT01312558', 'acronym': 'MEDOSAHS', 'briefTitle': 'The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Crete'}, 'orgStudyIdInfo': {'id': 'NCT01312558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prudent diet group', 'description': 'Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity.', 'interventionNames': ['Behavioral: Prudent diet group']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet group', 'description': 'Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity.', 'interventionNames': ['Behavioral: Mediterranean diet group']}], 'interventions': [{'name': 'Prudent diet group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Prudent diet group']}, {'name': 'Mediterranean diet group', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mediterranean diet group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2208', 'city': 'Heraklion', 'country': 'Greece', 'facility': 'University of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Crete', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Christopher Papandreou', 'investigatorFullName': 'Christopher Papandreou', 'investigatorAffiliation': 'University of Crete'}}}}