Clinical trial NCT05881824: PAP Adherence After Diet/Lifestyle Intervention in OSA Patients
Official title: PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
treatment adherence
Positive airway pressure (PAP) treatment
diet/lifestyle intervention
Mediterranean diet
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in PAP adherence
timeFrame: 6 months
Secondary outcomes:
measure: Difference in Body mass index
timeFrame: 6 months
measure: Difference in Blood pressure measurements
timeFrame: 6 months
measure: Difference in daytime sleepiness
timeFrame: 6 months
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University of Crete
state: Crete
Study officials:
affiliation: University of Crete
name: Sophia Schiza, MD
role: STUDY_CHAIR
References: