PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05881824
• Other study ID #: OSADIET1
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Greece	University of Crete	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in PAP adherence	Difference pre post in PAP adherence (hours of device use)	6 months
Secondary	Difference in Body mass index	Difference pre post intervention in Body mass index	6 months
Secondary	Difference in Blood pressure measurements	Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention	6 months
Secondary	Difference in daytime sleepiness	Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score	6 months