Validation of the Turkish Version of the S3-NIV Questionnaire

NCT07610122 | Not Yet Recruiting

• 1 other identifier: 26/40
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency; Chronic Respiratory Failure

Keywords

Non-Invasive Ventilation; Validation; Questionnaire; Reliability; S3-NIV

Outcome Measures

Primary Outcomes (1)

• Internal Consistency and Construct Validity of the Turkish S3-NIV

  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.

  Baseline (Day 0)

Secondary Outcomes (1)

• Test-Retest Reliability

  14 to 15 days after baseline

Study Arms (1)

Home NIV Patients

Patients with chronic respiratory failure who have been using home non-invasive ventilation (NIV) for at least 3 months and are in a clinically stable phase.

Other: Turkish Version of the S3-NIV Questionnaire

Interventions

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).

Home NIV Patients

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 patients with chronic respiratory failure who are followed up in the outpatient clinic and have been using a home non-invasive ventilation (NIV) device for at least 3 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Saglik Bilimleri University: lead

Study Sites (1)

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ipek Ozmen, Prof.

  Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Unsal, PT PhD(c)

CONTACT

+90 530 4641198; fztdlkunsal@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD (c)

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)