Clinical trial NCT06292325: Psychological Aspects in OSA
Official title: Psychological Aspects in Modifying Apnea/Hypopnea Indices and Nadir of Saturation in Obstructive Sleep Apnea Syndrome (OSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osa Syndrome
Keywords: Quality of life
Couple Relationship Quality
CPAP
Sleep Apnea
Sleep Disturbance
Adherence to treatment
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2024-03-05
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult OSA patients already adapted to CPAP therapy or who have just started adaptation to CPAP, with any severity level of disease and their bedpartners. So the study will include both the partners (Dyads).

Brief summary: The research project consists of an observational study. Obstructive Sleep Apnea (OSA) is a condition characterized by recurrent episodes of upper airway collapse during sleep, leading to decreased blood oxygen levels and disruptions of normal sleep patterns. Estimates of its prevalence vary, but its impact on patients' quality of life is evident.

Through a qualitative analysis (semi-structured interviews for both patients and bed partners) and a quantitative analysis (APIM Model), this research aims to explore the perception and awareness of the disease and its impact on the individual and couple's lives of patients with OSA and their bed partners, to assess patients' perceptions of the disease, illness management (CPAP experience) and symptoms, as well as their bed partners' perceptions. Moreover, psychological aspects of living with OSA, such as perceived stress, depression, anxiety, sleep quality, daily sleepiness will be studied to observe the association with Continuous Positive Airway Pressure (CPAP) adherence.

Detailed description: Firstly, a series of semi-structured interviews will be conducted with patients with OSA, at different levels of CPAP adaptation as well as with bed partners of patients who are experiencieng CPAP treatment with OSA.

After that, a quantitative analysis will be conducted to explore dyadic dynamics between patients with OSA and their bed partners.

Eligibility criteria: Inclusion Criteria:

* Adult outpatient patients
* over 18 years of age
* Diagnosis of Obstructive Sleep Apnea Syndrome
* Absence of cognitive impairments
* Having a bedpartner

Exclusion Criteria:

* Oncological comorbidities
* Dementia, as reported in the medical record
* Ongoing treatment with phosphodiesterase-5 inhibitors, hypogonadism, or severe lung diseases
* Exacerbations requiring hospitalization or the use of corticosteroids and antibiotics in the last two months
* Lack of consent
* Lack of a bedpartner

Primary outcomes:
measure: Brief Illness Perception Questionnaire (Brief IPQ)
timeFrame: from May 2023 to May 2024
measure: CPAP therapy adherence (hours/night)
timeFrame: from May 2023 to May 2024
measure: Dyadic Adjustment Scale (DAS)
timeFrame: from May 2023 to May 2024
Secondary outcomes:
measure: The experience in close relationships-revised (ECR-R) Scale
timeFrame: from May 2023 to May 2024
measure: The Psychological General Well-Being Index (PGWB-S)
timeFrame: from May 2023 to May 2024
measure: The Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: from May 2023 to May 2024
measure: The Generalized Anxiety Scale -7 (GAD-7)
timeFrame: from May 2023 to May 2024
measure: The Mannheim Dream Questionnaire (MADRE)
timeFrame: from May 2023 to May 2024
measure: The EP worth scale (ESS)
timeFrame: from May 2023 to May 2024
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: from May 2023 to May 2024
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
state: MI
Study officials:
References:
citation: Parish JM, Lyng PJ. Quality of life in bed partners of patients with obstructive sleep apnea or hypopnea after treatment with continuous positive airway pressure. Chest. 2003 Sep;124(3):942-7. doi: 10.1378/chest.124.3.942.
citation: Batool-Anwar S, Goodwin JL, Kushida CA, Walsh JA, Simon RD, Nichols DA, Quan SF. Impact of continuous positive airway pressure (CPAP) on quality of life in patients with obstructive sleep apnea (OSA). J Sleep Res. 2016 Dec;25(6):731-738. doi: 10.1111/jsr.12430. Epub 2016 May 30.
citation: Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8.
citation: Chu, C. M., Wu, S. Y., Yu, C. C., & Huang, C. Y. (2021). Sleep Disturbance and Depressive Tendency in Bed Partners of Patients With Obstructive Sleep Apnea.