NCT05881824

PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: University of Crete · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	MDG intervention	6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-03-30
• Completion: 2022-06-30
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: Greece