Psychological Aspects in OSA

Osa Syndrome Clinical Trial

— PSICOSA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06292325
• Other study ID #: FDG_88-17
• Status: Enrolling by invitation
• Start date: May 8, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

The 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 246
• Est. completion date: May 31, 2024
• Est. primary completion date: May 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osa Syndrome
• Syndrome

Intervention

Device:
• Continuous 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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan	MI

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Illness Perception Questionnaire (Brief IPQ)	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.	from May 2023 to May 2024
Primary	CPAP therapy adherence (hours/night)	CPAP therapy average daily adherence will be evaluated through data extraction from the integrated ventilator software during hospital visits.	from May 2023 to May 2024
Primary	Dyadic Adjustment Scale (DAS)	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.	from May 2023 to May 2024
Secondary	The experience in close relationships-revised (ECR-R) Scale	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.	from May 2023 to May 2024
Secondary	The Psychological General Well-Being Index (PGWB-S)	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.	from May 2023 to May 2024
Secondary	The Patient Health Questionnaire - 9 (PHQ-9)	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.	from May 2023 to May 2024
Secondary	The Generalized Anxiety Scale -7 (GAD-7)	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.	from May 2023 to May 2024
Secondary	The Mannheim Dream Questionnaire (MADRE)	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.	from May 2023 to May 2024
Secondary	The EP worth scale (ESS)	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.	from May 2023 to May 2024
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	from May 2023 to May 2024