Clinical Trials Directory

Trials / Completed

CompletedNCT06292325

Psychological Aspects in OSA

Psychological Aspects in Modifying Apnea/Hypopnea Indices and Nadir of Saturation in Obstructive Sleep Apnea Syndrome (OSA)

Status
Completed
Phase
Study type
Observational
Enrollment
246 (actual)
Sponsor
Fondazione Don Carlo Gnocchi Onlus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEContinuous Positive Airway Pressure (CPAP)CPAP is the gold standard therapy for Obstructive Sleep Apnea. It consists of a machine that delivers a constant and steady air pressure through a mask worn over the nose or both nose and mouth during sleep. This continuous flow of air helps to keep the airway open, preventing episodes of airway collapse and obstruction characteristic of OSA. CPAP therapy is highly effective in reducing symptoms such as snoring, daytime sleepiness, and fatigue, as well as improving overall sleep quality and decreasing the risk of complications associated with untreated OSA, such as cardiovascular issues. It is considered the gold standard treatment for moderate to severe OSA and is often prescribed after a sleep study confirms the diagnosis. CPAP machines come in various designs and features to suit individual needs and preferences, and proper adjustment and compliance are essential for optimal treatment outcomes.

Timeline

Start date
2023-05-08
Primary completion
2023-05-08
Completion
2024-09-30
First posted
2024-03-05
Last updated
2025-02-27

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06292325. Inclusion in this directory is not an endorsement.