Obstructive Sleep ApneaNCT05881824
PAP Adherence After Diet/Lifestyle Intervention in OSA Patients
A study testing MDG intervention in people with Obstructive Sleep Apnea, run by University of Crete at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- MDG intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- refusal to participate
- patients on PAP treatment
- current participation in a weight loss program
- central sleep apnea syndromes
- obesity hypoventilation syndrome
- restrictive ventilator syndromes
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- MDG intervention
- Keywords
- obstructive sleep apnea, treatment adherence, Positive airway pressure (PAP) treatment, diet/lifestyle intervention, Mediterranean diet
- Medical subject headings
- Sleep Apnea, Obstructive, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDG interventionBehavioural
6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MDG intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in PAP adherence
Difference pre post in PAP adherence (hours of device use)
Measured: 6 months
Secondary outcomes (3)
Difference in Body mass index
Difference pre post intervention in Body mass index
Measured: 6 months
Difference in Blood pressure measurements
Difference in Systolic and Diastolic Blood pressure measurements pre and post intervention
Measured: 6 months
Difference in daytime sleepiness
Difference ipre post intervention in daytime sleepiness assessed by Epworth Sleepiness Scale score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Dec 2021
- Primary completion30 Mar 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izolde Bouloukaki, University of Crete
- Investigators
- Sophia Schiza, MD, Study chair, University of Crete
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881824
- Sponsor's protocol ID
- OSADIET1
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAP Treatment Adherence Supported by Dietary Intervention Isimproved in Overweight and Obese Obstructive Sleep Apnea(OSA) Patients: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05881824
- Acronym / sponsor ID
- OSADIET1
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, treatment adherence, Positive airway pressure (PAP) treatment, diet/lifestyle intervention, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of CreteUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: MDG interventionThe MDG was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- refusal to participate
- patients on PAP treatment
- current participation in a weight loss program
- central sleep apnea syndromes
- obesity hypoventilation syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDG intervention6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet | Behavioural | Mediterranean diet group (MDG) |
Primary outcome
Difference in PAP adherence
Time frame: 6 months
Difference pre post in PAP adherence (hours of device use)
3 secondary outcomes
Difference in Body mass index
Time frame: 6 months
Difference in Blood pressure measurements
Time frame: 6 months
Difference in daytime sleepiness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Schiza, MD study chair
University of Crete
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDG intervention in people with Obstructive Sleep Apnea, run by University of Crete at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in PAP adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.