Clinical trial NCT06668597: Educational Motivational Program on Sleep Apnea
Official title: Evaluation of the Effectiveness of a Brief Motivational Educational Program to Improve Sleep Quality in OSA Patients Through Adherence to CPAP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Obstructive Sleep Apnea
Continuous Positive Airway Pressure
Motivational Intervention
Sleep Management
Telemedicine
Psychoeducation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to introduce a motivational intervention for patients with Obstructive Sleep Apnea (OSA) starting CPAP therapy to improve sleep quality and treatment adherence. It will assess average daily CPAP use and compare subjective sleep quality, daytime sleepiness, disease perception, and quality of life between the intervention group and a control group receiving standard care. Inclusion criteria are adults with OSA capable of understanding Italian; exclusion criteria are minors and those already adapted to CPAP. The experimental group will receive a four-phase motivational intervention, while the control group will follow standard CPAP adaptation without additional support.

Detailed description: The study aims to introduce a specific motivational intervention for patients with Obstructive Sleep Apnea (OSA) starting CPAP adaptation, aimed at improving sleep quality and disease management through good adherence to treatment. Additionally, the study will investigate adherence to the proposed treatment in both groups, using average daily use as an adherence indicator, defined as the total hours of CPAP divided by the total number of observation days. Secondary objectives include investigating the effectiveness of the motivational treatment on subjective sleep quality compared to the control group and assessing whether there are statistically significant differences between the clinical practice group (Control Group - GC) and the Experimental Group (GS) in terms of daytime sleepiness (ESS), sleep quality (PSQI), disease perceptions (B-IPQ), and quality of life related to the disease (SF-12). Inclusion criteria are adult patients with OSA (mild, moderate, severe) who are beginning their adaptation process to CPAP and can understand the Italian language. Exclusion criteria include minors, patients already adapted to CPAP, and those unable to understand the Italian language. During the ME-CA study at the Sleep Center, participants will undergo the following procedures to evaluate adaptation to CPAP therapy and its impacts on sleep quality and quality of life. Participants will have an initial evaluation with a pulmonologist in an outpatient setting at the Sleep Center (according to standard clinical practice). They will complete questionnaires to collect socio-demographic data, disease perception, daytime sleepiness, sleep quality, quality of life, and service usability at three different times: at enrollment (T0), one week after the intervention (T1), and three months after the conclusion of the intervention (T2). The adaptation process will follow the assigned protocol (GS or GC); specifically, the Experimental Group will receive a four-phase psychological-motivational intervention in addition to standard CPAP adaptation. Phase 1 (Pre-adaptation psychoeducation): Within two days prior to the home visit by the provider, which typically occurs within three days of the visit with the pulmonologist, participants will be shown an educational video on OSA (25 minutes) and provided with necessary supplies (device, masks, and tubing). Phase 2 (Motivational Interview): After the first night of titration and CPAP use, participants will be contacted for a brief motivational interview (25 minutes). Phase 3 (Psychological Support Interview): One week after the provider's intervention and the start of CPAP adaptation, participants will be contacted for a support interview (40 minutes), as the first week of adaptation is considered a high-risk period for abandoning device use. Phase 4 (Monitoring Interview): Two weeks after the provider's intervention and the beginning of CPAP adaptation, participants will be contacted for a monitoring interview (30 minutes) to ensure no difficulties or issues have arisen during the adaptation process. The frequency and duration of the CPAP adaptation will span a total of 16 days. During this period, participants in the Experimental Group (GS) will engage in four distinct phases, each involving specific meetings or evaluations totaling 120 minutes of participation. These will include psychoeducational sessions, motivational interviews, psychological support, and monitoring. The Control Group (GC), on the other hand, will follow the standard CPAP adaptation pathway without additional meetings or interventions during the initial 15-day adaptation period. Participants in the control group will follow the standard CPAP adaptation pathway. After the visit with the pulmonologist responsible for the Sleep Center, patients in the control group will be offered adaptation to CPAP therapy. They will then be contacted by the provider to arrange a home visit, usually within three days of the visit with the pulmonologist, during which the necessary supplies (device, masks, and tubing) will be provided. Following this, there will be a 15-day adaptation period during which the patient will use the device without further contact with medical staff or the provider. At the end of this period, if the patient has shown adequate adaptability to CPAP therapy, the physician will proceed with the final prescription of the device.

Eligibility criteria: Inclusion Criteria:

- Adult patients with OSA (divided, according to the Task Force of the American Academy of Sleep Medicine (Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The report of an American Academy of Sleep Medicine Task Force. Sleep. 1999;22(5):667-689) into: Mild OSA with AHI between 5 and 15 Moderate OSA with AHI between 15 and 30 Severe OSA with AHI \> 30

* OSA patients who need to begin their home adaptation process to CPAP
* OSA patients who are able to understand the Italian language

Exclusion Criteria:

* Minor patients
* Patients already adapted to CPAP
* Patients unable to understand the Italian language

Primary outcomes:
measure: Brief Illness Perception Questionnaire
timeFrame: At enrollment, one week after the end of the intervention and three months later.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At enrollment, one week after the end of the intervention and three months later.
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At enrollment, one week after the end of the intervention and three months later.
Secondary outcomes:
measure: Short Form Health Survey - 12
timeFrame: At enrollment, one week after the end of the intervention and three months later.
measure: Self-Efficacy Measure for Sleep Apnea (SEMSA)
timeFrame: At enrollment and one week after the end of the intervention
measure: System Usability Scale (SUS)
timeFrame: At enrollment, one week after the end of the intervention and three months later.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Fondazione Don Gnocchi
state: MI
city: Milan
country: Italy
facility: Don Gnocchi Foundation
Study officials:
affiliation: IRCCS Fondazione Don Gnocchi
name: Eleonora Volpato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampaio R, Pereira MG, Winck JC. Psychological morbidity, illness representations, and quality of life in female and male patients with obstructive sleep apnea syndrome. Psychol Health Med. 2012;17(2):136-49. doi: 10.1080/13548506.2011.579986. Epub 2011 Jul 11.
citation: Poletti V, Battaglia EG, Banfi P, Volpato E. Effectiveness of continuous positive airway pressure therapy on romantic relationships and intimacy among individuals with obstructive sleep apnea: A systematic review and a meta-analysis. J Sleep Res. 2025 Feb;34(1):e14262. doi: 10.1111/jsr.14262. Epub 2024 Jun 24.
citation: Shapiro GK, Shapiro CM. Factors that influence CPAP adherence: an overview. Sleep Breath. 2010 Dec;14(4):323-35. doi: 10.1007/s11325-010-0391-y. Epub 2010 Jul 27.
citation: Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.