OSA Patients' and Bed-Partners' Illness Perceptions in CPAP Therapy Adaptation Process (NCT07150611) | Clinical Trial Compass
CompletedNot Applicable
OSA Patients' and Bed-Partners' Illness Perceptions in CPAP Therapy Adaptation Process
Italy24 participantsStarted 2023-06-05
Plain-language summary
This study explores how psychological and relationship factors influence the success of CPAP therapy in people with Obstructive Sleep Apnea (OSA) and their partners. CPAP therapy is a common treatment for OSA, yet many patients struggle to keep using it consistently. Our research aims to identify what helps or hinders patients and their partners in adhering to CPAP therapy, including their illness perceptions, how they cope with treatment and how their relationship dynamics affect their experience. By understanding these factors, we hope to provide valuable insights to better support both patients and their bed partners, leading to improved treatment adherence and quality of life for couples managing OSA.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For patients:
Inclusion Criteria:
* Adult partcipants with mild (Apnea/Hypopnea Index, AHI between 5 and 15), moderate (AHI between 15 and 30), or severe (AHI greater than 30) OSA (Young et al., 2009), as certified by a pulmonologist at the recruitment centre, with a stable bed partner;
* Participants with OSA awaiting CPAP therapy initiation, or those who are either adherent or non-adherent within the first year of CPAP use or who have been using CPAP for over a year;
* Participants who provided informed consent to participate in the study;
* Participants who are proficient in the Italian language.
Exclusion Criteria:
* Participants who did not provide informed consent to participate;
* Participants who do not speak Italian;
* Participants who have not been diagnosed with OSA and for whom CPAP therapy is not deemed necessary or who are not currently undergoing CPAP therapy;
* Participants with OSA without a stable bed partner;
* Participants with significant psychiatric comorbidities or with other significant organic pathologies where OSA is not the primary health concern, according to medical records;
For bedpartners
Inclusion criteria:
* Bed partners in a stable relationship with an OSA patient for whom CPAP therapy adaptation has been deemed necessary or who are already adapted to CPAP therapy;
* Bed partners who have provided informed consent to participate;
* Bed partners who are proficient in the Italian language.
Exclusion criteria:
* Bed partners who did not…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Experience of CPAP usage and adaptation and lived OSA condition
Timeframe: From enrollment to the end of the interviews one week later