Obstructive Sleep ApnoeaMEDOSAHSNCT01312558
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
A study testing Prudent diet group and Mediterranean diet group in people with Obstructive Sleep Apnoea and Hypopnoea Syndrome, run by University of Crete at 1 site in Greece.
Trial summary
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnoea, Hypopnoea Syndrome
- What is being tested?
- Prudent diet group and Mediterranean diet group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with apnoea-hypopnoea index >15/h and Epworth Sleepiness Scale > 10
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.
Read the 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.
- Conditions
- Obstructive Sleep Apnoea, Hypopnoea Syndrome
- Being tested
- Prudent diet group, Mediterranean diet group
- Keywords
- obstructive sleep apnoea/hypopnoea syndrome, Mediterranean diet, exercise, weight loss, continuous positive airway pressure, lipid peroxidation
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prudent diet groupBehavioural
Mediterranean diet groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Prudent diet group | Experimental | Participants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity. Receives: Behavioral: Prudent diet group |
| Mediterranean diet group | Experimental | Participants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity. Receives: Behavioral: Mediterranean diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Papandreou, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312558
- Sponsor's protocol ID
- NCT01312558
- Acronym
- MEDOSAHS
- Status last verified
- Feb 2014
- First submitted
- 7 Mar 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26015461Papandreou 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.
PubMed 22034645Papandreou 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.
PubMed 21918812
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
- ClinicalTrials.gov ID
- NCT01312558
- Acronym / sponsor ID
- MEDOSAHS / NCT01312558
- Conditions
- Obstructive Sleep Apnoea, Hypopnoea Syndrome
- Keywords
- obstructive sleep apnoea/hypopnoea syndrome, Mediterranean diet, exercise, weight loss, continuous positive airway pressure, lipid peroxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prudent diet group | Experimental | Behavioral: Prudent diet groupParticipants follow CPAP therapy, a prudent diet while receiving counselling to increase their physical activity. |
| Mediterranean diet group | Experimental | Behavioral: Mediterranean diet groupParticipants follow CPAP therapy, Mediterranean diet, while receiving counselling to increase their physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with apnoea-hypopnoea index >15/h and Epworth Sleepiness Scale > 10
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prudent diet group | Behavioural | Prudent diet group |
| Mediterranean diet group | Behavioural | Mediterranean diet group |
Primary outcome
OSAS severity
The primary outcome measure was the change in OSAS severity as reflected mainly by AHI and saturation indexes.
1 secondary outcome
AHI during REM sleep and lipid peroxidation marker TBARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 26015461Papandreou 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.
- Derived from this study: PubMed 22034645Papandreou 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.
- Derived from this study: PubMed 21918812Papandreou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prudent diet group and Mediterranean diet group in people with Obstructive Sleep Apnoea and Hypopnoea Syndrome, run by University of Crete at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSAS severity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312558, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.