Status:
COMPLETED
OSA Patients' and Bed-Partners' Illness Perceptions in CPAP Therapy Adaptation Process
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Conditions:
OSA - Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Obstructive Sleep Apnea (OSA) is a common condition that disrupts sleep due to repeated interruptions in breathing, which can lead to daytime fatigue, mood issues, and health risks like heart disease....
Eligibility Criteria
Inclusion
- For patients:
- 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
- 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 provide informed consent;
- Bed partners who do not speak Italian;
- Bed partners without a stable relationship with an OSA patient for whom CPAP therapy adaptation has been deemed necessary or who are already adapted to CPAP therapy;
Key Trial Info
Start Date :
June 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07150611
Start Date
June 5 2023
End Date
May 22 2024
Last Update
September 2 2025
Active Locations (1)
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1
IRCCS Fondazione Don Gnocchi
Milan, MI, Italy, 20148