Psychological Aspects in OSA
- Conditions
- Osa Syndrome
- Registration Number
- NCT06292325
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
- Adult outpatient patients
- over 18 years of age
- Diagnosis of Obstructive Sleep Apnea Syndrome
- Absence of cognitive impairments
- Having a bedpartner
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brief Illness Perception Questionnaire (Brief IPQ) from May 2023 to May 2024 It is a self-administered questionnaire consisting of nine items rated on a scale of 0-10. The first five items assess cognitive perceptions such as the impact on life (item 1); duration of illness (item 2); disease control (item 3); beliefs about treatment effectiveness (item 4); and symptom experience (item 5). Items 6 and 8 assess emotional aspects, such as concern about the illness and mood. Item 7 assesses the level of understanding of the illness. The last item requires respondents to rank the three factors that caused the illness. Cut-offs for the total score are determined as follows: \<42 indicates a mild threat, 42-49 indicates a moderate threat, and ≥50 indicates a high threat.
CPAP therapy adherence (hours/night) from May 2023 to May 2024 CPAP therapy average daily adherence will be evaluated through data extraction from the integrated ventilator software during hospital visits.
Dyadic Adjustment Scale (DAS) from May 2023 to May 2024 A self-administered questionnaire consisting of 32 items divided into 4 subscales: "Consensus on important issues," "Satisfaction with relationship status," "Doing things together," and "Satisfaction with emotional and sexual life." To obtain the interpretation of the questionnaire, the average score for each area is calculated, noting that in the responses to questions 30 and 31, the corresponding score is 0 for NO and 1 for YES.
- Secondary Outcome Measures
Name Time Method The Mannheim Dream Questionnaire (MADRE) from May 2023 to May 2024 It is a 21-items scale used to explore dream content on a 7-point Likert scale, from 0 (never) to 6 (almost every morning). It consists of a series of structured questions aimed at investigating various aspects of the dream experience.
The experience in close relationships-revised (ECR-R) Scale from May 2023 to May 2024 It is a self-administered questionnaire, consisting of two subscales of 18 items each, which assess Avoidance and Anxiety related to attachment in relationships with romantic partners. The items are rated on a 7-point Likert scale (1=strongly disagree; 7=strongly agree), with higher scores indicating greater attachment avoidance and anxious attachment with romantic partners.
The Patient Health Questionnaire - 9 (PHQ-9) from May 2023 to May 2024 It consists of 9 items corresponding to symptoms of major depression according to the DSM-IV. Scores range from 0 to 27. Scores between 0 and 9 indicate subthreshold depression. A score of 10 is identified as the point where the sensitivity and specificity of the instrument are recognized as optimal for detecting clinically significant depression.
The Generalized Anxiety Scale -7 (GAD-7) from May 2023 to May 2024 It's a 7 items scale, designed to assess the severity of generalized anxiety disorder symptoms. Comprising seven items that inquire about common anxiety symptoms such as feeling nervous, worrying excessively, and experiencing restlessness. Each item on the scale is scored on a Likert scale ranging from 0 to 3, with responses indicating the frequency of symptoms over the past two weeks. The total score ranges from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
The EP worth scale (ESS) from May 2023 to May 2024 A self-administered questionnaire, consisting of 8 items, on a 4-step Likert scale (0-3), regarding usual lifestyle habits in the recent period, aimed at exploring the presence of daytime sleepiness. Scores ≥10 indicate excessive daytime sleepiness.
Pittsburgh Sleep Quality Index (PSQI) from May 2023 to May 2024 A self-administered tool consisting of 19 items that assesses sleep quality. Patients can be classified as High Risk (if there are 2 or more categories in which the score is positive) or Low Risk (if there are no categories present or only one in which the score is positive), based on their responses to individual items and their overall scores in symptom categories; in addition, the 5 questions intended for the bed partner will also be included.
The Psychological General Well-Being Index (PGWB-S) from May 2023 to May 2024 The short version with 6 items of the self-administered questionnaire composed of 22 items, which provides a subjective assessment of one's psychological well-being, on a 6-step Likert scale (0-5). Higher scores indicate greater psychological well-being.
Trial Locations
- Locations (1)
IRCCS Fondazione Don Carlo Gnocchi
🇮🇹Milan, MI, Italy