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Completed

NCT Number: NCT05881824

PAP Adherence After Diet/Lifestyle Intervention in OSA Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Crete

Heraklion, Crete, 71110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MDG intervention

Behavioral

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

Primary outcomes

  1. Difference in PAP adherence

    Time frame: 6 months

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

Secondary outcomes

  1. Difference in Body mass index

    Time frame: 6 months

    Difference pre post intervention in Body mass index

  2. Difference in Blood pressure measurements

    Time frame: 6 months

    Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention

  3. Difference in daytime sleepiness

    Time frame: 6 months

    Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 31, 2023
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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