Psychological Aspects in Modifying Apnea/Hypopnea Indices and Nadir of Saturation in Obstructive Sleep Apnea Syndrome (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Brief Illness Perception Questionnaire (Brief IPQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult outpatient patients
- •over 18 years of age
- •Diagnosis of Obstructive Sleep Apnea Syndrome
- •Absence of cognitive impairments
- •Having a bedpartner
排除标准
- •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
结局指标
主要结局
Brief Illness Perception Questionnaire (Brief IPQ)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- The Mannheim Dream Questionnaire (MADRE)(from May 2023 to May 2024)
- The experience in close relationships-revised (ECR-R) Scale(from May 2023 to May 2024)
- The Patient Health Questionnaire - 9 (PHQ-9)(from May 2023 to May 2024)
- The Generalized Anxiety Scale -7 (GAD-7)(from May 2023 to May 2024)
- The EP worth scale (ESS)(from May 2023 to May 2024)
- Pittsburgh Sleep Quality Index (PSQI)(from May 2023 to May 2024)
- The Psychological General Well-Being Index (PGWB-S)(from May 2023 to May 2024)
研究者
Eleonora Volpato
Clinical Professor
Fondazione Don Carlo Gnocchi Onlus