Psychological Aspects in OSA

NCT06292325 | Completed DMC

• 1 other identifier: FDG_88-17
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Osa Syndrome

Keywords

Quality of life; Couple Relationship Quality; CPAP; Sleep Apnea; Sleep Disturbance; Adherence to treatment

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• The experience in close relationships-revised (ECR-R) Scale

  from May 2023 to May 2024

• The Psychological General Well-Being Index (PGWB-S)

  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 Mannheim Dream Questionnaire (MADRE)

  from May 2023 to May 2024

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Catholic University of the Sacred Heart: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, MI, 20148, Italy

Location

Related Publications (4)

• 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.

  PMID: 12970021 BACKGROUND

• 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.

  PMID: 27242272 BACKGROUND

• 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.

  PMID: 21652236 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Carnevale syndrome; Sleep Apnea Syndromes; Parasomnias; Treatment Adherence and Compliance

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: May 8, 2023
• Primary Completion: May 8, 2023
• Study Completion: September 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)