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The MotivAir Study to Improve CPAP Adherence in OSAS Patients

NCT05767190 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-03-22

No results posted yet for this study

Summary

This study aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing (MI) principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS).

Methods. A multicenter randomized controlled trial (RCT) design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program (usual care plus MI) with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients.

A minimum sample of 80 participants (40 patients per group) will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary (adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index, AHI) and secondary (motivation, perceived competence, quality of life, sleepiness, as well as the emotional state, daily life activities, and quality of the social relationships of the person) outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation

Conditions

  • Sleep Apnea, Obstructive
  • Motivational Interviewing

Interventions

BEHAVIORAL

Motivational interviewing

During the intervention, the trained-nurse will provide a motivational interviewing-based intervention consisting of one session divided into two parts: educational (the concepts of sleep apnea and the symptoms, and the CPAP treatment will be focused on) and training activity (using MI not directly advocate for behavioral change (i.e., use CPAP as prescribed), but asks key questions to help the patient explore conflicting feelings about the change, weighs the positive consequences and negatives of this change, and allows the patient to realize the discrepancy between current risk behavior (i.e. not using CPAP as directed) and the patient's self-identified goals. The intervention will be tailored on the patient's stage of change based on Prochaska and DiClemente transtheoretical model (1982), in fact, the nurse will use MI not only at the beginning of therapy but also in every contact with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc.).

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Gianluca Castelnuovo, PhD · Istututo Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-03-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767190 on ClinicalTrials.gov