Sleep Apnea, Obstructive Clinical Trial
— MotivAirOfficial title:
The MotivAir Study: a Randomized Controlled Trial of Motivational Interviewing-Based Intervention to Improve Adherence to CPAP in Patients With Obstructive Sleep Apnea Syndrome
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
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - having a diagnosis of OSAS confirmed by polysomnography; - being recommended for treatment with CPAP; - being naïve to this type of intervention Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Italy | San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS | Verbania |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline adherence to CPAP at 6 months | average hours of usage per night | 6 months from CPAP initiation | |
Primary | Change from baseline Apnea-Hypopnea Index (AHI) at 6 months | severity of apnea-hypopnea | 6 months from CPAP initiation | |
Secondary | Change from baseline Motivation to change at 6 months | the need for changes in your lifestyle to make it healthier with a single item | 6 months from CPAP initiation | |
Secondary | Change from baseline of Evaluation of Perceived Competence in Adherence to CPAP in OSAS at 3 and 6 months | self-efficacy in overcoming barriers associated with the use of the cpap | 6 months from CPAP initiation | |
Secondary | Change from Baseline of Visual Analogical Well-being Scale for apnea at 6 months | quality of life | 6 months from CPAP initiation |
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