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

NCT07258264 | Completed DMC

• 1 other identifier: 3687
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. Secondary outcomes were the motivation, perceived competence, quality of life, sleepiness, emotional state, activities and social relations.

Conditions

Apnea (Central and Obstructive)

Outcome Measures

Primary Outcomes (1)

• Adherence

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

  From enrollment to the end of treatment at 90 days.

Secondary Outcomes (7)

• Motivation for the use of CPAP treatment.

  Baseline, 30 days and 90 days

• Perceived competence

  Baseline, 30 days and 90 days

• Well-being

  Baseline, 30 days and 90 days.

• Sleepiness

  Baseline, 30 days and 90 days

• Emotional state

  Baseline, day 30 and day 90.

Study Arms (2)

Competency-based learning - Control

ACTIVE COMPARATOR

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.

Behavioral: Competency-based learning

Motivational Interviewing - MEntA

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing (MI)

Interventions

Motivational Interviewing (MI) BEHAVIORAL

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

Motivational Interviewing - MEntA

Competency-based learning BEHAVIORAL

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

Competency-based learning - Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Liquide Healthcare Spain: lead

Study Sites (1)

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Related Publications (1)

• 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.

  PMID: 37497068 RESULT

MeSH Terms

Conditions

Apnea

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, single-centre trial design was performed

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 2, 2025
• Study Start: May 30, 2019
• Primary Completion: October 21, 2019
• Study Completion: October 21, 2019
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

ES (1)