Respiratory InsufficiencyNCT07610122
Validation of the Turkish Version of the S3-NIV Questionnaire
An observational study of Respiratory Insufficiency and Chronic Respiratory Failure, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Chronic Respiratory Failure
- What is being tested?
- Turkish Version of the S3-NIV Questionnaire
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
Dilek Ünsal, PT PhD(c), +905304641198, fztdlkunsal@gmail.com
About this study
Official title: Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)
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.
Read the detailed description
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.
- Being tested
- Turkish Version of the S3-NIV Questionnaire
- Keywords
- Non-Invasive Ventilation, Validation, Questionnaire, Reliability, S3-NIV
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of the S3-NIV QuestionnaireOther
An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Turkish Version of the S3-NIV Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0)
Secondary outcomes (1)
Test-Retest Reliability
Evaluated using the Intraclass Correlation Coefficient (ICC) between the first and second administrations of the questionnaire in a randomly selected subgroup.
Measured: 14 to 15 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start21 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Unsal, Istanbul Saglik Bilimleri University
- Investigators
- Ipek Ozmen, Prof., Principal investigator, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610122
- Sponsor's protocol ID
- 26/40
- Status last verified
- Nov 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A decision on sharing individual participant data (IPD) has not yet been made. Data sharing may be considered upon reasonable request to the principal investigator after the publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)
- ClinicalTrials.gov ID
- NCT07610122
- Acronym / sponsor ID
- 26/40
- Keywords
- Non-Invasive Ventilation, Validation, Questionnaire, Reliability, S3-NIV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home NIV Patients | – | Other: Turkish Version of the S3-NIV QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of the S3-NIV QuestionnaireAn 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV). | Other | Home NIV Patients |
Primary outcome
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.
1 secondary outcome
Test-Retest Reliability
Time frame: 14 to 15 days after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. A decision on sharing individual participant data (IPD) has not yet been made. Data sharing may be considered upon reasonable request to the principal investigator after the publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipek Ozmen, Prof. principal investigator
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Chronic Respiratory Failure, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 4 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Unsal, PT PhD(c) (+90 530 4641198, fztdlkunsal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency and Construct Validity of the Turkish S3-NIV (time frame: Baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.