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Apnea (Central and Obstructive)MEntA ProgramNCT07258264

MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)

A study testing Motivational Interviewing (MI) and Competency-based learning in people with Apnea (Central and Obstructive), run by Air Liquide Healthcare Spain at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence. The main outcome was the adherence with the CPAP therapy after 90 days of treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Apnea (Central and Obstructive)
What is being tested?
Motivational Interviewing (MI) and Competency-based learning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
30 May 2019to 21 Oct 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To have a diagnosis of OSA confirmed by polysomnography (PSG)
  • CPAP treatment prescription
  • First time with this type of intervention.

Who cannot join

  • Subjects requiring bi-level ventilation
  • Pacients with central sleep apnoea syndrome
  • Patients with severe chronic obstructive pulmonary disease (COPD)
  • Patients with cognitive disorders and those unable to understand the consent form to participate.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario de La Princesa

    Madrid, Madrid, 28006

Other trials in Spain

About this study

Official title: Programa Educativo y Formativo Basado en la Entrevista Motivacional Para Pacientes Con SAHS en Tratamiento Con CPAP: MEntA

A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence. The main outcome was the adherence with the CPAP therapy after 90 days of treatment. Secondary outcomes were the motivation, perceived competence, quality of life, sleepiness, emotional state, activities and social relations.

Read the detailed description

The subjects enrolled in the study were required to have a diagnosis of OSA confirmed by polysomnography (PSG), be recommended for treatment with CPAP and be naïve to this type of intervention. The study excluded subjects requiring bi-level ventilation, such as those with central sleep apnoea syndrome, a CPAP assessment study, those with severe chronic obstructive pulmonary disease (COPD), cognitive disorders and those unable to understand the consent form to participate. Prior to enrolment in the study, all patients were informed in detail about the study and signed the consent form to participate. Standard of Care Group: subjects undergoing this training intervention follow the standard procedure. It consists of a CPAP School for the initiation of therapy, and follow-up visits (in person and/or by telephone) that follow the frequencies indicated by the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR). The CPAP School consists of a single session lasting around 80 minutes. The theoretical training includes the importance of adherence, as well as handling the equipment and accessories, cleaning and maintenance of the equipment, and prevention of complications and possible side effects. The practical training consists of showing patients how to carry out the technique themselves.

MEntA Group: subjects in this group underwent an intervention based on the motivational interviewing (MI) technique in CPAP School format for the initiation of therapy, and follow-up as indicated by SEPAR. MEntA CPAP School intervention consists of one session lasting approximately 90 minutes, which is divided into two blocks: educational activity and training activity. In the first block, an expert explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block was reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA has the specific contents but the key is in how these contents are treated with the patients, using the MI to the treatment of OSA with CPAP.

For perceived competence was used the validated Questionnaire of Evaluation of Perceived Competence in Adherence to CPAP in OSA (CEPCA)9. This questionnaire consists of 3 categories and 13 items: knowledge of OSA and its associated risk; expectations regarding CPAP treatment; and confidence in overcoming obstacles associated with the use of this type of treatment. The scores obtained in the CEPCA imply they are positively related to quality of life and motivation and negatively related to daytime sleepiness.

The quality of life was assessed using the Visual Analogical Well-being Scale for apnoea10 and sleepiness was assessed using the Epworth Sleepiness Scale (ESS)11,12. Finally, emotional state, daily activities and social relationships were also measured using the following ad hoc question "Taking into account your sleep problems, how would say you are in terms of mood / activities / social relationships?". The answer alternatives are: Good, Normal / no change, Bad.

Being tested
Motivational Interviewing (MI), Competency-based learning
Medical subject headings
Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing (MI)Behavioural

    Collaborative and person-centered counseling style designed to help people explore and resolve their ambivalence about change, thereby strengthening their intrinsic motivation to make positive behavioral changes

  • Competency-based learningBehavioural

    Consists of exposing the contents in a "classroom" format and promoting the acquisition of the contents of each aspect through practice. The training focuses on the skills of handling and use of CPAP

Study groups in NCT07258264
Study groupRoleWhat they receive
Competency-based learning - ControlActive comparatorStandard of Care Group: subjects undergoing this training intervention follow the standard procedure. It consists of a CPAP School for the initiation of therapy, and follow-up visits (in person and/or by telephone) that follow the frequencies indicated by the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR). The CPAP School consists of a single session lasting around 80 minutes. The theoretical training includes the importance of adherence, as well as handling the equipment and accessories, cleaning and maintenance of the equipment, and prevention of complications and possible side effects. The practical training consists of showing patients how to carry out the technique themselves.
Receives: Behavioral: Competency-based learning
Motivational Interviewing - MEntAExperimentalsubjects in this group underwent an intervention based on the motivational interviewing (MI) technique in CPAP School format for the initiation of therapy, and follow-up as indicated by SEPAR. MEntA CPAP School intervention consists of one session lasting approximately 90 minutes, which is divided into two blocks: educational activity and training activity. In the first block, an expert explains the concepts of sleep apnoea and the symptoms, while a patient shows the CPAP treatment and how to optimize this to the fullest. This block was reinforced with documentation in hard copy and digital format. The second block on training activity was based on working with the treatment, equipment, safety, hygiene and advice. MEntA has the specific contents but the key is in how these contents are treated with the patients, using the MI to the treatment of OSA with CPAP.
Receives: Behavioral: Motivational Interviewing (MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence

    Total number of night-time hours registered by the CPAP device

    Measured: From enrollment to the end of treatment at 90 days.

Secondary outcomes (7)
  1. Motivation for the use of CPAP treatment.

    Set of factors, both internal and external, that drive a person to initiate, maintain, and direct their behavior toward the use of CPAP. The Motivation to Use CPAP Scale (MUC-S) is used for its evaluation. It is a 5-point Likert-type scale from strongly agree (5) to strongly disagree (1). The possible range for the scale is 9-45. A higher score indicates greater motivation to use CPAP treatment.

    Measured: Baseline, 30 days and 90 days

  2. Perceived competence

    An individual's subjective belief in their own effectiveness and ability to learn and execute skills within a specific context, such as academics or social interactions. The OSA-CPAP Perceived Competence Evaluation Interview, composed of 13 items with a Yes or No response option, is used for its evaluation. Minimum score = 0; Maximum score = 13. The higher the score, the more competent the patient perceives himself to be in the use of CPAP and the better his self-efficacy.

    Measured: Baseline, 30 days and 90 days

  3. Well-being

    Subjective perception of a person about their overall well-being. For its evaluation, Visual analogical well-being scale for sleep apnea is used. It consists of a 120-mm straight line on which the patient indicates his or her health status with respect to the symptoms which were the motivation for the consultation (e.g., OSA). The ends of the line indicate the least favorable and the most favorable well-being status. It functions as an Analog Rating Scale, with scores ranging from 0 (minimum) to 10 (maximum). The higher the score, the better the well-being in relation to the symptoms of obstructive sleep apnea.

    Measured: Baseline, 30 days and 90 days.

  4. Sleepiness

    Strong desire to sleep or a state of excessive drowsiness. For its evaluation, the Epworth test is used, a self-administered questionnaire with eight questions used to measure a person's general level of daytime sleepiness. It assesses the likelihood of dozing off in common situations, and a total score is calculated from (0) (never doze) to (3) (high chance of dozing) for each question. Minimum score = 0 and maximum score = 24. Scores between 0-10 are considered normal; scores between 11-14 are considered mild daytime sleepiness; scores between 15-18 are considered moderate daytime sleepiness; scores between 19-24 are considered severe daytime sleepiness.

    Measured: Baseline, 30 days and 90 days

  5. Emotional state

    Individual's experience of feelings and moods, such as happiness, sadness, anger, or anxiety, which can be influenced by internal factors and external events. For its evaluation, an ad hoc scale with 3 possible categories is used, which the patient chooses: bad (score 0), normal (score 1), better (score 2). A higher score is interpreted as a better mood

    Measured: Baseline, day 30 and day 90.

  6. Daily activities

    Regular actions people perform each day, encompassing personal care (like bathing and eating), work or school, and leisure (like reading or hobbies). For its evaluation, an ad hoc scale with 3 possible categories is used, which the patient chooses: bad (score 0), normal (score 1), better (score 2). A higher score is interpreted as a greater ability to perform activities of daily living.

    Measured: Baseline, Day 30 and Day 90

  7. Social relationships

    Regular actions people perform each day, encompassing personal care (like bathing and eating), work or school, and leisure (like reading or hobbies). For its evaluation, an ad hoc scale with 3 possible categories is used, which the patient chooses: bad (score 0), normal (score 1), better (score 2). A higher score is interpreted as a greater ability to participate in social activities.

    Measured: Baseline, Day 30 and Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start30 May 2019
  3. Primary completion21 Oct 2019
  4. Study completion21 Oct 2019

Resources

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
Model description
A randomized, controlled, single-centre trial design was performed
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07258264
Sponsor's protocol ID
3687
Acronym
MEntA Program
Status last verified
Nov 2025
First submitted
26 Sep 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Rudilla D, Landete P, Zamora E, Roman A, Vergara I, Ancochea J. MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP): A Randomized Controlled Trial. Open Respir Arch. 2021 Mar 16;3(2):100088. doi: 10.1016/j.opresp.2021.100088. eCollection 2021 Apr-Jun.

    PubMed 37497068

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing (MI) and Competency-based learning in people with Apnea (Central and Obstructive), run by Air Liquide Healthcare Spain at 1 site in Spain.

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 3 inclusion and 4 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 2 Dec 2025. 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 Spain. 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?

Adherence (time frame: From enrollment to the end of treatment at 90 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07258264, which also lists 1 linked publication.

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 2 Dec 2025.

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