Psychological morbidity, illness representations, and quality of life in female and male patients with obstructive sleep apnea syndrome.
Rute Sampaio, M Graça Pereira, João C Winck
https://pubmed.ncbi.nlm.nih.gov/21745022Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06668597
Evaluation of the Effectiveness of a Brief Motivational Educational Program to Improve Sleep Quality in OSA Patients Through Adherence to CPAP
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-10
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a motivational intervention for adults with Obstructive Sleep Apnea (OSA) who are starting CPAP therapy. The study aims to improve sleep quality and treatment adherence by comparing a special motivational program with standard care. It will measure daily CPAP use and assess differences in sleep quality, daytime sleepiness, disease perception, and quality of life between the two groups. Participants are divided into two groups: an experimental group receiving a four-phase motivational psychoeducational program and a control group following standard CPAP adaptation without extra support. The motivational program includes an educational video before starting CPAP, a motivational phone interview after the first night, a psychological support interview one week after starting treatment, and a monitoring interview two weeks after beginning CPAP use. The CPAP adaptation period lasts about 15 to 16 days. Participants will have an initial evaluation with a pulmonologist and complete questionnaires on sleep quality, daytime sleepiness, disease perception, quality of life, and service usability at three time points: enrollment, one week post-intervention, and three months later. The study will monitor adherence using average daily CPAP use and evaluate outcomes through validated tools such as the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and others. The total participation involves the adaptation period plus follow-up assessments to understand the impact of the motivational program.
CONDITIONS
Brief Title
Educational Motivational Program on Sleep Apnea
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients with Obstructive Sleep Apnea (OSA), including mild, moderate, and severe cases
- Patients who need to begin their home adaptation process to CPAP
- Patients able to understand the Italian language
You will not qualify if you...
- Minors (patients under 18 years old)
- Patients already adapted to CPAP
- Patients unable to understand the Italian language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) with a pulmonologist for initial evaluation and enrollment
CPAP Adaptation
Duration - 15 to 16 days
Participants begin home adaptation to CPAP therapy with device setup and initial use.
1 home visit to receive CPAP device and supplies; additional phone contacts for the experimental group
Motivational Educational Intervention (Experimental Group Only)
Duration - 16 days concurrent with CPAP adaptation
Participants in the experimental group receive a four-phase motivational program including psychoeducation, motivational and psychological support interviews, and monitoring to improve adherence to CPAP therapy.
4 phone interviews: one before adaptation, one after first night of use, one at 1 week, and one at 2 weeks
Follow-up Assessments
Duration - 3 months
Participants complete questionnaires assessing sleep quality, daytime sleepiness, disease perception, and quality of life at multiple time points after intervention.
3 assessments: at enrollment, 1 week after intervention ends, and 3 months post-intervention
Trial Site Locations
Total: 2 locations
1
Don Gnocchi Foundation
Milan, Milan, Italy, 20148
Actively Recruiting
2
IRCCS Fondazione Don Gnocchi
Milan, MI, Italy, 20148
Actively Recruiting
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Research Team
E
Eleonora Volpato, PhD
V
Valentina Poletti, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
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.
Valentina Poletti, Elvia Giovanna Battaglia, Paolo Banfi...
https://pubmed.ncbi.nlm.nih.gov/38925562Factors that influence CPAP adherence: an overview.
Gilla K Shapiro, Colin M Shapiro
https://pubmed.ncbi.nlm.nih.gov/20661654The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial.
Agnes Y K Lai, Daniel Y T Fong, Jamie C M Lam...
https://pubmed.ncbi.nlm.nih.gov/24810282