The MotivAir Study to Improve CPAP Adherence in OSAS Patients

NCT05767190 | Unknown

• 1 other identifier: 03J101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from Baseline adherence to CPAP at 6 months

  average hours of usage per night

  6 months from CPAP initiation

• Change from baseline Apnea-Hypopnea Index (AHI) at 6 months

  severity of apnea-hypopnea

  6 months from CPAP initiation

Secondary Outcomes (3)

• Change from baseline Motivation to change at 6 months

  6 months from CPAP initiation

• Change from baseline of Evaluation of Perceived Competence in Adherence to CPAP in OSAS at 3 and 6 months

  6 months from CPAP initiation

• Change from Baseline of Visual Analogical Well-being Scale for apnea at 6 months

  6 months from CPAP initiation

Study Arms (2)

MotivAir group

EXPERIMENTAL

Subjects in the MotivAir group will follow an intervention - lasting approximately 45 minutes - based on motivational interviewing principles and techniques delivered by a trained nurse.

Behavioral: Motivational interviewing

Treatment as usual

NO INTERVENTION

Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery.

Interventions

Motivational interviewing BEHAVIORAL

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.).

MotivAir group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• having a diagnosis of OSAS confirmed by polysomnography;
• being recommended for treatment with CPAP;
• being naïve to this type of intervention

You may not qualify if:

• use of oxygen therapy \> 2 l/min;
• history of severe cognitive disorders;
• history of COPD: FEV1/FVC (Tiffeneau Index) ≤ 60% with FEV1 ≤ 50%;
• dyspnea on exertion (Borg \> 6);
• diagnosis of Long Covid or Covid-19 infection \< 4 months;
• chronic heart failure (NYHA: Grade III and IV);
• unstable ischemic heart disease;
• inability to understand the consent to participate;
• patient refusal.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, 28921, Italy

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gianluca Castelnuovo, PhD

  Istututo Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Castelnuovo, PhD

CONTACT

0039323514338; gianluca.castelnuovo@unicatt.it

Giada Pietrabissa, PhD

CONTACT

0039323514338; giada.pietrabissa@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: March 14, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)