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CompletedNCT07150611CPAP-IPAUpdated Sep 2, 2025

OSA Patients' and Bed-Partners' Illness Perceptions in CPAP Therapy Adaptation Process

An observational study in OSA - Obstructive Sleep Apnea, sponsored by Fondazione Don Carlo Gnocchi ETS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Fondazione Don Carlo Gnocchi ETS · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • OSA - Obstructive Sleep Apnea

Keywords

  • Illness Perceptions
  • Bed Partners
  • OSA
  • CPAP therapy
  • CPAP adaptation
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

This study's enrollment of 24 is below the median of 104 across 648 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 36 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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).

Eligibility criteria

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 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;
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the end of the interviews one week later

07

Study locations

1 site
  • IRCCS Fondazione Don Gnocchi
    Milan, MI 20148, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07150611
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Responsible party
Eleonora Volpato (Clinical Professor, Fondazione Don Carlo Gnocchi ETS) — Principal investigator
First posted
Sep 2, 2025
Start date
Jun 5, 2023
Primary completion
May 22, 2024
Completion
May 22, 2024
Last update
Sep 2, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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