PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

University of Crete74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

MDG interventionBEHAVIORAL

6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged \>18 years with newly diagnosed moderate to severe OSA \[apnea-hypopnea index (AHI)≥15 events/h\] through an attended overnight polysomnographyaccording to standard criteria * overweight and obese \[BMI\>25 kg/m2\] * eligible for PAP treatment with adherence data available in the 6-months after initiation of treatment and * with an above-elementary school education. Exclusion Criteria: * refusal to participate * patients on PAP treatment * current participation in a weight loss program * central sleep apnea syndromes * obesity hypoventilation syndrome * restrictive ventilator syndromes * severe congestive heart failure * a history of life-threatening arrhythmias * severe cardiomyopathy * long-term oxygen therapy * chronic kidney disease * family or personal history of mental illness * drug or alcohol abuse * severe cognitive impairment * concurrent oncological diseases * pregnancy or lactatio * recent hospitalization for acute or chronic respiratory disease * history of narcolepsy or restless leg syndrome

Locations (1)

University of Crete

Heraklion, Crete, Greece

Outcomes

Primary Outcomes

Difference in PAP adherence

Difference pre post in PAP adherence (hours of device use)

Time frame: 6 months

Secondary Outcomes

Difference in Body mass index

Difference pre post intervention in Body mass index

Time frame: 6 months

Difference in Blood pressure measurements

Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention

Time frame: 6 months

Difference in daytime sleepiness

Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score

Time frame: 6 months

Data from ClinicalTrials.gov

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