OSA - Obstructive Sleep ApneaCPAP-IPANCT07150611
OSA Patients' and Bed-Partners' Illness Perceptions in CPAP Therapy Adaptation Process
An observational study of OSA - Obstructive Sleep Apnea, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2023to 22 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obstructive Sleep Apnea (OSA) patients and their bed partners at 3 different step of OSA management. The subgroups included: * (1) OSA patients and bed partners before starting CPAP therapy (T0) * (2) OSA patients and bed partners within the first year of CPAP use (T1) * (3) OSA patients and bed partners beyond one year of CPAP use (T2).
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Perspective Interpretative Phenomenological Analysis of Patient and Bed Partner Experiences With CPAP Therapy Adaptation in Obstructive Sleep Apnoea
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.
Read the 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. Continuous Positive Airway Pressure (CPAP) therapy is the primary treatment, helping keep airways open during sleep and improving overall health. However, despite its benefits, many people find CPAP difficult to use consistently. Patients may feel uncomfortable or self-conscious about wearing the device, particularly around their partners, which can impact their relationships and adherence to treatment.
This study takes a unique approach by examining how OSA and CPAP therapy impact not only patients but also their "bed partners"-typically a spouse or close companion who shares their sleeping environment. Bed partners often play a supportive role, helping the patient manage OSA and adjust to CPAP therapy. Yet, little research has focused on how the partner's involvement, perceptions, and reactions influence the patient's experience and adherence to treatment.
Using the Interpretative Phenomenological Analysis (IPA) methodology with a Multi-Perspective approach, this study enables a dual view on the experiences of both patients and bed partners, offering an in-depth look at their shared journey with CPAP. Participants are recruited from the Sleep Medicine Clinic at Don Gnocchi in Milan and divided into three subgroups based on their stage in the CPAP adaptation process: T0, pre-adaptation; T1, within the first year of adaptation; and T2, following the first year of adaptation. This division allows for a nuanced understanding of how attitudes and experiences with CPAP may evolve over time.
Our study examines the psychological and relational aspects that affect CPAP adherence, seeking to uncover both the challenges and supports involved. Using the Common Sense Model of Illness Representation as a theoretical framework, we explore how the patient's and partner's understanding of OSA and CPAP can shape their responses and behavior. This model suggests that how people perceive an illness can strongly affect their actions, including their coping strategies. By studying both the patient's and partner's views, we aim to identify areas of potential miscommunication or stress that may hinder adherence and to find ways for healthcare providers to offer targeted support.
By focusing on the relationship between patients and bed partners, this study seeks to enhance our understanding of the social and emotional dynamics around CPAP therapy, which could lead to improved patient adherence and well-being.
- Conditions
- OSA - Obstructive Sleep Apnea
- Keywords
- Illness Perceptions, Bed Partners, OSA, CPAP therapy, CPAP adaptation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T0-OSA Patients | OSA patients who are to be started on CPAP therapy but have not yet begun the adaptation process. | |
| T1-OSA Patients | OSA patients in their first year of CPAP adaptation. | |
| T2-OSA Patients | Patients who have been adapted to CPAP for over a year. | |
| T0-BedPartner | Bed partners of OSA patients who have to be adapted to CPAP therapy | |
| T1-BedPartner | Bedpartners of OSA patients in their first year of CPAP adaptation. | |
| T2-Bedpartner | bedpartners of patients who have been adapted to CPAP for over a year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of CPAP usage and adaptation and lived OSA condition
A multi-perspective (patients and bed partners) interpretative phenomenological analysis was used to explore, throung semistructured interviews, the lived esxperience of living with OSA and useing CPAP.
Measured: From enrollment to the end of the interviews one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start5 Jun 2023
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150611
- Sponsor's protocol ID
- 04_26/04/2023
- Acronym
- CPAP-IPA
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Perspective Interpretative Phenomenological Analysis of Patient and Bed Partner Experiences With CPAP Therapy Adaptation in Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT07150611
- Acronym / sponsor ID
- CPAP-IPA / 04_26/04/2023
- Conditions
- OSA - Obstructive Sleep Apnea
- Keywords
- Illness Perceptions, Bed Partners, OSA, CPAP therapy, CPAP adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Continuous Positive Airway Pressure (CPAP) therapy is the primary treatment, helping keep airways open during sleep and improving overall health. However, despite its benefits, many people find CPAP difficult to use consistently. Patients may feel uncomfortable or self-conscious about wearing the device, particularly around their partners, which can impact their relationships and adherence to treatment.
This study takes a unique approach by examining how OSA and CPAP therapy impact not only patients but also their "bed partners"-typically a spouse or close companion who shares their sleeping environment. Bed partners often play a supportive role, helping the patient manage OSA and adjust to CPAP therapy. Yet, little research has focused on how the partner's involvement, perceptions, and reactions influence the patient's experience and adherence to treatment.
Using the Interpretative Phenomenological Analysis (IPA) methodology with a Multi-Perspective approach, this study enables a dual view on the experiences of both patients and bed partners, offering an in-depth look at their shared journey with CPAP. Participants are recruited from the Sleep Medicine Clinic at Don Gnocchi in Milan and divided into three subgroups based on their stage in the CPAP adaptation process: T0, pre-adaptation; T1, within the first year of adaptation; and T2, following the first year of adaptation. This division allows for a nuanced understanding of how attitudes and experiences with CPAP may evolve over time.
Our study examines the psychological and relational aspects that affect CPAP adherence, seeking to uncover both the challenges and supports involved. Using the Common Sense Model of Illness Representation as a theoretical framework, we explore how the patient's and partner's understanding of OSA and CPAP can shape their responses and behavior. This model suggests that how people perceive an illness can strongly affect their actions, including their coping strategies. By studying both the patient's and partner's views, we aim to identify areas of potential miscommunication or stress that may hinder adherence and to find ways for healthcare providers to offer targeted support.
By focusing on the relationship between patients and bed partners, this study seeks to enhance our understanding of the social and emotional dynamics around CPAP therapy, which could lead to improved patient adherence and well-being.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| T0-OSA Patients | – | –OSA patients who are to be started on CPAP therapy but have not yet begun the adaptation process. |
| T1-OSA Patients | – | –OSA patients in their first year of CPAP adaptation. |
| T2-OSA Patients | – | –Patients who have been adapted to CPAP for over a year. |
| T0-BedPartner | – | –Bed partners of OSA patients who have to be adapted to CPAP therapy |
| T1-BedPartner | – | –Bedpartners of OSA patients in their first year of CPAP adaptation. |
| T2-Bedpartner | – | –bedpartners of patients who have been adapted to CPAP for over a year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive Sleep Apnea (OSA) patients and their bed partners at 3 different step of OSA management. The subgroups included: * (1) OSA patients and bed partners before starting CPAP therapy (T0) * (2) OSA patients and bed partners within the first year of CPAP use (T1) * (3) OSA patients and bed partners beyond one year of CPAP use (T2).
Key inclusion criteria (7 listed)
- 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.
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experience of CPAP usage and adaptation and lived OSA condition
Time frame: From enrollment to the end of the interviews one week later
A multi-perspective (patients and bed partners) interpretative phenomenological analysis was used to explore, throung semistructured interviews, the lived esxperience of living with OSA and useing CPAP.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA - Obstructive Sleep Apnea, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of CPAP usage and adaptation and lived OSA condition (time frame: From enrollment to the end of the interviews one week later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.