Back to resultsPAP Adherence After Diet/Lifestyle Intervention in OSA Patients
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
MDG intervention
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, treatment adherence, Positive airway pressure (PAP) treatment, diet/lifestyle intervention, Mediterranean diet
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
Sites / Locations
- University of Crete
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
standard care group (SCG)
Mediterranean diet group (MDG)
Arm Description
The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits
The MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet.
Outcomes
Primary Outcome Measures
Difference in PAP adherence
Difference pre post in PAP adherence (hours of device use)
Secondary Outcome Measures
Difference in Body mass index
Difference pre post intervention in Body mass index
Difference in Blood pressure measurements
Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention
Difference in daytime sleepiness
Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05881824
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, treatment adherence, Positive airway pressure (PAP) treatment, diet/lifestyle intervention, Mediterranean diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care group (SCG)
Arm Type
No Intervention
Arm Description
The SCG received oral healthy lifestyle advice and counseling on physical activity and sleep habits
Arm Title
Mediterranean diet group (MDG)
Arm Type
Active Comparator
Arm Description
The MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet.
Intervention Type
Behavioral
Intervention Name(s)
MDG intervention
Intervention Description
6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet
Primary Outcome Measure Information:
Title
Difference in PAP adherence
Description
Difference pre post in PAP adherence (hours of device use)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Difference in Body mass index
Description
Difference pre post intervention in Body mass index
Time Frame
6 months
Title
Difference in Blood pressure measurements
Description
Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention
Time Frame
6 months
Title
Difference in daytime sleepiness
Description
Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia Schiza, MD
Organizational Affiliation
University of Crete
Official's Role
Study Chair
Facility Information:
Facility Name
University of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
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PAP Adherence After Diet/Lifestyle Intervention in OSA Patients
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