PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

NCT ID: NCT05881824

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-06-30

Brief Summary

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

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard care group (SCG)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mediterranean diet group (MDG)

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

Group Type: ACTIVE_COMPARATOR

MDG intervention

Intervention Type: BEHAVIORAL

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

Interventions

MDG intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

Clinical Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia Schiza, MD

Role: STUDY_CHAIR

University of Crete

Locations

University of Crete

Heraklion, Crete, Greece

Countries

Greece

Other Identifiers

OSADIET1

Identifier Type: -

Identifier Source: org_study_id