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The aim of this study is to explore the role of diet/lifestyle intervention on Positive airway pressure (PAP) treatment adherence in patients with obstructive sleep apnea (OSA).Specifically, we evaluated the effects of a combination of PAP and weight-loss Mediterranean diet intervention on improving PAP adherence, Body mass index (ΒΜΙ), daytime symptoms, mainly sleepiness and arterial blood pressure measurements over the effect of standard care alone.
We designed a parallel, randomized, controlled, clinical trial. Eligible participants are adult, overweight and obese men and women, diagnosed with moderate-to-severe OSA [apnea-hypopnea index (AHI)≥15 events/h] through an attended overnight polysomnography. Participants, after written informed consent, were blindly randomized to a standard care group (SCG, n=37) and a Mediterranean diet group (MDG, n=37). Study groups were prescribed PAP. The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits, while the MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. PAP adherence (hours of device use), BMI, daytime sleepiness, evaluated by Epworth Sleepiness Scale (ESS) and arterial blood pressure measurements were evaluated pre- and post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care group (SCG) | No Intervention | The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits | |
| Mediterranean diet group (MDG) | Active Comparator | The MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDG intervention | Behavioral | 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in PAP adherence | Difference pre post in PAP adherence (hours of device use) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Body mass index | Difference pre post intervention in Body mass index | 6 months |
| Difference in Blood pressure measurements | Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophia Schiza, MD | University of Crete | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Crete | Heraklion | Crete | 71110 | Greece |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 6 months |
| Difference in daytime sleepiness | Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score | 6 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |