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Osa SyndromePSICOSANCT06292325

Psychological Aspects in OSA

An observational study of Osa Syndrome, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osa Syndrome
What is being tested?
Continuous Positive Airway Pressure (CPAP)
Type of treatment
Medical device
How many people
246 participants
Where
1 siteItaly
Study dates
8 May 2023to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Fondazione Don Carlo Gnocchi

    Milan, MI, 20148

Other trials in Italy

About this study

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

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.

Read the 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
Osa Syndrome
Being tested
Continuous Positive Airway Pressure (CPAP)
Keywords
Quality of life, Couple Relationship Quality, CPAP, Sleep Apnea, Sleep Disturbance, Adherence to treatment
Medical subject headings
Carnevale syndrome, Sleep Apnea Syndromes, Parasomnias, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: from May 2023 to May 2024

  2. CPAP therapy adherence (hours/night)

    CPAP therapy average daily adherence will be evaluated through data extraction from the integrated ventilator software during hospital visits.

    Measured: from May 2023 to May 2024

  3. 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.

    Measured: from May 2023 to May 2024

Secondary outcomes (7)

  1. 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.

    Measured: from May 2023 to May 2024

  2. 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.

    Measured: from May 2023 to May 2024

  3. 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.

    Measured: from May 2023 to May 2024

  4. 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.

    Measured: from May 2023 to May 2024

  5. 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.

    Measured: from May 2023 to May 2024

  6. 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.

    Measured: from May 2023 to May 2024

  7. 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.

    Measured: from May 2023 to May 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2024
  2. Study start8 May 2023
  3. Primary completion8 May 2023
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06292325
Sponsor's protocol ID
FDG_88-17
Acronym
PSICOSA
Status last verified
Feb 2025
First submitted
27 Feb 2024
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27242272

  • 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.

    PubMed 21652236

  • 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.

    PubMed 12970021

Questions about this trial

What is this clinical trial studying?

An observational study of Osa Syndrome, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief Illness Perception Questionnaire (Brief IPQ) (time frame: from May 2023 to May 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06292325, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

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