PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

University of Crete

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: MDG intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05881824

OSADIET1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

standard care group (SCG)

No Intervention group

Description:

The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits

Mediterranean diet group (MDG)

Active Comparator group

Description:

The MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet.

Treatment:

Behavioral: MDG intervention