PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

NCT05881824 | Completed

• 1 other identifier: OSADIET1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; treatment adherence; Positive airway pressure (PAP) treatment; diet/lifestyle intervention; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Difference in PAP adherence

  Difference pre post in PAP adherence (hours of device use)

  6 months

Secondary Outcomes (3)

• Difference in Body mass index

  6 months

• Difference in Blood pressure measurements

  6 months

• Difference in daytime sleepiness

  6 months

Study Arms (2)

standard care group (SCG)

NO INTERVENTION

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

Mediterranean diet group (MDG)

ACTIVE COMPARATOR

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

Behavioral: MDG intervention

Interventions

MDG intervention BEHAVIORAL

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

Mediterranean diet group (MDG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

University of Crete

Heraklion, Crete, 71110, Greece

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Health Behavior; Behavior

Study Officials

• Sophia Schiza, MD

  University of Crete

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: December 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)