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

NCT07150611 | Completed DMC

• 1 other identifier: 04_26/04/2023
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

OSA - Obstructive Sleep Apnea

Keywords

Illness Perceptions; Bed Partners; OSA; CPAP therapy; CPAP adaptation

Outcome Measures

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.

  From enrollment to the end of the interviews one week later

Study Arms (6)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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;

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Gnocchi

Milan, MI, 20148, Italy

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: June 5, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

IT (1)