PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: MDG intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care group (SCG)<br>The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits | |
| Active Comparator: Mediterranean diet group (MDG)<br>The MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. | Behavioral: MDG intervention<br>* 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in PAP adherence | Difference pre post in PAP adherence (hours of device use) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 6 months | 
| Difference in daytime sleepiness | Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, treatment adherence, Positive airway pressure (PAP) treatment, diet/lifestyle intervention, Mediterranean diet