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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	8 February 2021
Main ID:	NCT02515357
Date of registration:	28/07/2015
Prospective Registration:	Yes
Primary sponsor:	Harokopio University
Public title:	Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
Scientific title:	The MIMOSA (Mediterranean Diet/Lifestyle Intervention for the Management of Obstructive Sleep Apnea) Study
Date of first enrolment:	September 7, 2015
Target sample size:	187
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02515357
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Greece

Contacts

Name:	Meropi D Kontogianni, PhD
Address:
Telephone:
Email:
Affiliation:	Harokopio University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Presence of obstructive sleep apnea diagnosed through polysomnography

2. Presence of overweight or obesity (Body Mass Index > 25 kg/m2)

Exclusion Criteria:

1. Presence of central sleep apnea

2. Presence of other causes of sleep disorders, such as narcolepsy, restless leg syndrome
or chronic pain syndrome

3. Hospitalization during the last year due to acute or chronic respiratory disease or
required use of supplemental oxygen

4. Presence of diabetes mellitus

5. Presence of cardiovascular disease

6. Presence of severe hypertension (blood pressure > 160/95 mm Hg)

7. Presence of neoplasm

8. Presence of chronic inflammatory diseases

9. Presence of psychiatric disorders, such as major depression, schizophrenia or suicidal
ideation

10. Pregnancy or breast feeding (for women)

11. Surgery during the last three months

12. Reception of antipsychotics, antidepressants or other sleep inducing drugs, systematic
reception of steroids or hormone replacement therapy for women

13. Excessive alcohol consumption (> 210 or > 140 gr of alcohol per week for men and
women, respectively)

14. Adherence to a hypocaloric diet for weight loss or changes in dietary habits during
the last six months

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obstructive Sleep Apnea

Intervention(s)

Behavioral: Mediterranean diet

Behavioral: Standard care

Behavioral: Mediterranean lifestyle

Primary Outcome(s)

Severity of obstructive sleep apnea [Time Frame: 6 months]

Secondary Outcome(s)

Daytime sleepiness [Time Frame: 6 months]

Oxidative stress [Time Frame: 6 months]

Subclinical inflammation [Time Frame: 6 months]

Sleep quality [Time Frame: 6 months]

Insulin resistance [Time Frame: 6 months]

Metabolic syndrome prevalence (%) [Time Frame: 6 months]

Physical and mental health [Time Frame: 6 months]

Secondary ID(s)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National and Kapodistrian University of Athens

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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