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NCT Number: NCT07610122

Validation of the Turkish Version of the S3-NIV Questionnaire

This study aims to evaluate the psychometric properties, including reliability and validity, of the Turkish version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV). The S3-NIV is a specific tool designed to assess difficulties and compliance in patients receiving home non-invasive ventilation. A total of 120 stable patients using home NIV for at least 3 months will be enrolled across multiple centers.

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Key information

Conditions

Respiratory Insufficiency Chronic Respiratory Failure Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, 34854, Turkey (Türkiye)

Location contact

Dilek Ünsal, PT PhD(c)

CONTACT

[email protected]

+905304641198

About this study

Following the official linguistic validation process authorized by the Mapi Research Trust, this multi-center observational study will assess the psychometric validity of the Turkish S3-NIV questionnaire. Patients will complete the 11-item S3-NIV questionnaire alongside a sociodemographic and clinical data form. To evaluate test-retest reliability, a randomly selected subgroup of patients (n=40) will re-complete the questionnaire 14 to 15 days after the initial administration. Internal consistency, construct validity (via factor analysis), and criterion validity (correlations with clinical parameters such as daily NIV usage hours and blood gas values) will be analyzed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with chronic respiratory failure requiring home non-invasive ventilation (NIV).
  • Using a home NIV device for at least 3 months.
  • Being in a clinically stable phase (no exacerbation or hospitalization in the last 1 month).
  • Able to understand and answer the questionnaire.
  • Provided written informed consent.

Exclusion criteria

  • Acute respiratory failure or clinical instability.
  • Severe cognitive impairment or psychiatric disorders preventing reliable communication.
  • Active malignancy or terminal illness with a short life expectancy.
  • Refusal to provide informed consent.

Treatment and study plan

Turkish Version of the S3-NIV Questionnaire

Other

An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV).

Primary outcomes

  1. Internal Consistency and Construct Validity of the Turkish S3-NIV

    Time frame: Baseline (Day 0)

    Evaluated using Cronbach's alpha coefficient for internal consistency and Confirmatory/Exploratory Factor Analysis (CFA/EFA) to confirm the structural validity of the 11-item scale.

Secondary outcomes

  1. Test-Retest Reliability

    Time frame: 14 to 15 days after baseline

    Evaluated using the Intraclass Correlation Coefficient (ICC) between the first and second administrations of the questionnaire in a randomly selected subgroup.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Unsal, PT PhD(c)

CONTACT

[email protected]

+90 530 4641198

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Registry information

Official study title

Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 27, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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