University of Crete
Heraklion, Crete, 71110, Greece
NCT Number: NCT05881824
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Heraklion, Crete, 71110, Greece
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet
Time frame: 6 months
Difference pre post in PAP adherence (hours of device use)
Time frame: 6 months
Difference pre post intervention in Body mass index
Time frame: 6 months
Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention
Time frame: 6 months
Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score
University of Crete
Other
PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial
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