Clinical trial Recruiting at 1 site Observational Ages 18 and up

Turkish version of the S3-NIV questionnaire: testing its reliability for home NIV patients

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

Run by Istanbul Saglik Bilimleri University · NCT07610122 · Data updated 2026-11-12

We’re testing whether the Turkish S3-NIV questionnaire reliably measures how well patients on home non-invasive ventilation can manage daily use and comfort.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorIstanbul Saglik Bilimleri University
Academic / other
Locations1 site (Istanbul)
StatusRecruiting
StartedMay 21, 2026
Main results expectedJune 30, 2027
Study endsAugust 31, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT07610122 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with chronic respiratory failure using home NIV for at least 3 months, clinically stable, and able to understand Turkish.

Probably not a fit

Patients not expected to benefit are those with acute instability, cognitive impairment preventing questionnaire completion, or lacking informed consent.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center observational study will translate and validate the Turkish S3-NIV questionnaire for adults with chronic respiratory failure using home NIV. About 120 stable patients from several centers will complete the 11-item survey, along with demographic and clinical data. A subset of 40 participants will repeat the survey after 14–15 days to assess test-retest reliability; analyses will examine internal consistency, factor structure, and correlations with clinical parameters like NIV usage hours and blood gas values.

Why it matters

Potential benefit: If successful, Turkish clinicians and researchers will have a reliable tool to assess patient experience with home NIV.

How similar studies have gone: Similar validation efforts for patient-reported tools in NIV populations have shown good reliability and validity, supporting this study’s approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Ipek Ozmen, Prof. — Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
  • Study coordinator: Dilek Unsal, PT PhD(c)
  • Email: fztdlkunsal@gmail.com
  • Phone: +90 530 4641198

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.