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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Istanbul Saglik Bilimleri University Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | May 21, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07610122 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.
-
Early Non-Invasive Ventilation in ALS
This study tests whether starting non-invasive ventilation earlier in adults with ALS can help improve breathing and quality of life.
-
Bedside Spirometry to see if tidal volume matches ideal body weight in non-intubated ARDS
This pilot study tests whether tidal volume measured at bedside with high-flow oxygen and after NIV settings can help classify ARDS patients who are not intubated.
-
Early breathing therapy just one hour after CABG extubation
This trial tests whether starting respiratory physiotherapy one hour after extubation improves recovery for adults after elective CABG compared with starting on the first postoperative day.
-
Humidification methods in trauma ICU patients on mechanical ventilation
This study tests whether active heated humidifiers or passive heat-and-moisture exchangers work better in trauma ICU patients who need long-term mechanical ventilation.
-
Extra oxygen during the 6-minute walk for people with chronic respiratory failure or exercise-related low oxygen
This trial will test whether giving extra oxygen during a 6-minute walk helps people with chronic respiratory failure or exertional low oxygen from COPD or interstitial lung disease walk farther, breathe better, and feel easier during the test.
-
Machine learning to detect inspiratory leak in long-term non-invasive ventilation
This project tries to use a machine-learning program to detect inspiratory leaks in people with chronic respiratory failure who use long-term non-invasive ventilation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.