Noninvasive VentilationNCT06343324
Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home
A study testing Web-based education in people with Noninvasive Ventilation and COPD, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, COPD
- What is being tested?
- Web-based education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Individuals who have used NIV at home for at least 4 months or more,
- Adults over the age of 18
- No communication barrier,
- Whether the caregiver or the individual himself is using a smart phone,
- Having internet access,
- Ability to read and understand Turkish.
Who cannot join
- Myocardial infarction or cerebrovascular accident, schizophrenia, etc. in the last 3 months. Individuals who cannot provide their own self-care due to illness,
- Being diagnosed with cancer,
- Being hospitalized with acute exacerbation,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Konya Beyhekim Training and Research Hospital
Konya, Selçuklu, 42060
About this study
Official title: The Effect of Web-Based "NIV Living Training" on NIV Compliance and Insomnia Severity in Individuals Using Noninvasive Ventilators (NIV) at Home: Randomized Controlled Study
Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV.
Read the detailed description
Support will be received from a software expert in mobile application development. The Mobile Application will be given the short name "Breathe", which indicates that it is an application application. The mobile application is planned to consist of 7 interfaces. 1.Interface: Training on Living with NIV - Password and Information General information about Living with NIV Training will be included. It is an interface where individuals can log in to the system with their password and information.
2.Interface: What is BIPAP? This interface will include general information about individuals' intended use of NIV, what it does, and how to select equipment.
3.Interface: Maintenance and cleaning of the device This interface will contain information on when and how the NIV device and equipment should be cleaned.
4.Interface: Most frequently asked questions about BIPAP treatment This interface will include the problems that individuals frequently experience when using NIV and tips on how to solve these problems.
Interface 5: Insomnia and coping methods This interface will contain information about insomnia and what techniques to use to cope with insomnia. It will also include sleep exercise to help you fall asleep.
6.Interface: Trainings This interface; It will consist of educational content such as breathing exercise, lung cleaning technique, breathing control in daily life activities (walking, bathing, climbing stairs, etc.), personal hygiene and dressing, and communication and special situations while using NIV.
7.Interface: Communication It is an interface where individuals can communicate with the researcher and ask questions.
Individuals assigned to the experimental group Individuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application once a week to consolidate their knowledge, and text message alerts will be sent via mobile phone. S³-NIV Questionnaire and ISI forms will be applied to the experimental group again in the first week, 4th week and 8th week.
Individuals assigned to the control group Written educational material was sent to individuals in the control group. S³-NIV Questionnaire and ISI forms will be applied again to the control group in the first week, 4th week and 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group.
- Conditions
- Noninvasive Ventilation, COPD
- Being tested
- Web-based education
- Keywords
- copd, bıpap, cpap, noninvasive ventilation, home type non invasive ventilation, web-based education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based educationBehavioural
Patients using noninvasive ventilation at home will receive detailed information about accessing, logging in and using web-based training. Pretest data will be collected, then week 4 and week 8 data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Individuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application twice a week to reinforce their knowledge, and text message alerts will be sent via mobile phone. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied to the experimental group as pre-test data. The scales will be applied again to the experimental group, which continues education for 8 weeks, in the 4th week and the 8th week. Receives: Behavioral: Web-based education |
| Control Group | No intervention | Written educational material was sent to individuals in the control group. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied as pre-test data to the control group, which is not given any training other than written material. During the 8-week period, the scales will be applied to the control group again in the 4th week and the 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
S³-NIV Questionnaire Total Score
Description: The questionnaire was developed to evaluate noninvasive ventilation at home. The survey consists of 10 items and two sub-dimensions. A five-point Likert scale is used to rate the items: always yes (0), mostly yes (1), sometimes yes (2), mostly no (3), completely no (4). The Cronbach alpha reliability coefficient of the survey was found to be 0.77. Score of the survey total and sub-dimensions; It is obtained by taking the average of the total score of the items and multiplying the result by 2.5. The lowest possible score (0) corresponds to the highest impact of disease and treatment, while the highest possible score (10) corresponds to the lowest impact of disease and treatment.
Measured: Baseline, Week 4, and Week 8
Insomnia Severity Index (ISI) Total Score
This scale is used for routine screening and the clinical assessment of insomnia to identify sleep disturbances. It consists of seven items and two sub-dimensions. It is a 5-point Likert-type scale where each item is scored from 0 to 4, resulting in a total score ranging from 0 to 28. Scores of 0-7 indicate subclinical insomnia, 8-14 indicate mild insomnia, 15-21 indicate moderate insomnia, and 22-28 indicate severe insomnia. The scale's internal consistency is 0.79.
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (2)
S³-NIV Respiratory Symptoms Subscale Score
Evaluated using the Respiratory Symptoms subscale of the S³-NIV Questionnaire. This subscale comprises 4 items (items 1, 4, 5, and 6) rated on a 5-point Likert scale ranging from 0 (always yes) to 4 (completely no). The total score ranges from 0 to 16 points. Lower scores indicate more severe respiratory symptoms, while higher scores reflect fewer respiratory symptoms and better patient adaptation to noninvasive ventilation (NIV) use.
Measured: Baseline, Week 4, and Week 8
S³-NIV Sleep/NIV-Related Side Effects Subscale Score
Evaluated using the Sleep and NIV-Related Side Effects subscale of the S³-NIV Questionnaire. This subscale comprises 6 items (items 2, 3, 7, 8, 9, and 10) rated on a 5-point Likert scale ranging from 0 (always yes) to 4 (completely no). The total score ranges from 0 to 24 points. Lower scores indicate more severe side effects and sleep disturbances related to ventilation, while higher scores reflect fewer symptoms and better adaptation to home NIV treatment.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Oct 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şahabettin Eriş, KTO Karatay University
- Investigators
- Şahabettin ERİŞ, MScN, Principal investigator, study principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343324
- Sponsor's protocol ID
- 2023/012
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be collected by the researcher at the University of Health Sciences Konya Beyhekim Training and Research Hospital.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based "NIV Living Training" on NIV Compliance and Insomnia Severity in Individuals Using Noninvasive Ventilators (NIV) at Home: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06343324
- Acronym / sponsor ID
- 2023/012
- Conditions
- Noninvasive Ventilation, COPD
- Keywords
- copd, bıpap, cpap, noninvasive ventilation, home type non invasive ventilation, web-based education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 2 Apr 2024 (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.
Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV.
Detailed description
Support will be received from a software expert in mobile application development. The Mobile Application will be given the short name "Breathe", which indicates that it is an application application. The mobile application is planned to consist of 7 interfaces. 1.Interface: Training on Living with NIV - Password and Information General information about Living with NIV Training will be included. It is an interface where individuals can log in to the system with their password and information.
2.Interface: What is BIPAP? This interface will include general information about individuals' intended use of NIV, what it does, and how to select equipment.
3.Interface: Maintenance and cleaning of the device This interface will contain information on when and how the NIV device and equipment should be cleaned.
4.Interface: Most frequently asked questions about BIPAP treatment This interface will include the problems that individuals frequently experience when using NIV and tips on how to solve these problems.
Interface 5: Insomnia and coping methods This interface will contain information about insomnia and what techniques to use to cope with insomnia. It will also include sleep exercise to help you fall asleep.
6.Interface: Trainings This interface; It will consist of educational content such as breathing exercise, lung cleaning technique, breathing control in daily life activities (walking, bathing, climbing stairs, etc.), personal hygiene and dressing, and communication and special situations while using NIV.
7.Interface: Communication It is an interface where individuals can communicate with the researcher and ask questions.
Individuals assigned to the experimental group Individuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application once a week to consolidate their knowledge, and text message alerts will be sent via mobile phone. S³-NIV Questionnaire and ISI forms will be applied to the experimental group again in the first week, 4th week and 8th week.
Individuals assigned to the control group Written educational material was sent to individuals in the control group. S³-NIV Questionnaire and ISI forms will be applied again to the control group in the first week, 4th week and 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Web-based educationIndividuals in the experimental group will be informed about the mobile application. The web-based mobile application called "Training for Living with NIV" prepared by the researcher will be installed on the mobile phone of the individual or his caregiver. They will be asked to log in to the web-based "NIV Living Training" mobile application twice a week to reinforce their knowledge, and text message alerts will be sent via mobile phone. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied to the experimental group as pre-test data. The scales will be applied again to the experimental group, which continues education for 8 weeks, in the 4th week and the 8th week. |
| Control Group | No intervention | –Written educational material was sent to individuals in the control group. Patient Descriptive Characteristics Form, S³-NIV Questionnaire and Insomnia Severity Index scales will be applied as pre-test data to the control group, which is not given any training other than written material. During the 8-week period, the scales will be applied to the control group again in the 4th week and the 8th week. After the 8th week data collection, web-based "NIV Survival Training" will also be given to individuals in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals who have used NIV at home for at least 4 months or more,
- Adults over the age of 18
- No communication barrier,
- Whether the caregiver or the individual himself is using a smart phone,
- Having internet access,
Key exclusion criteria (3 listed)
- Myocardial infarction or cerebrovascular accident, schizophrenia, etc. in the last 3 months. Individuals who cannot provide their own self-care due to illness,
- Being diagnosed with cancer,
- Being hospitalized with acute exacerbation,
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 |
|---|---|---|
| Web-based educationPatients using noninvasive ventilation at home will receive detailed information about accessing, logging in and using web-based training. Pretest data will be collected, then week 4 and week 8 data will be collected. | Behavioural | Experimental |
Primary outcome
S³-NIV Questionnaire Total Score
Time frame: Baseline, Week 4, and Week 8
Description: The questionnaire was developed to evaluate noninvasive ventilation at home. The survey consists of 10 items and two sub-dimensions. A five-point Likert scale is used to rate the items: always yes (0), mostly yes (1), sometimes yes (2), mostly no (3), completely no (4). The Cronbach alpha reliability coefficient of the survey was found to be 0.77. Score of the survey total and sub-dimensions; It is obtained by taking the average of the total score of the items and multiplying the result by 2.5. The lowest possible score (0) corresponds to the highest impact of disease and treatment, while the highest possible score (10) corresponds to the lowest impact of disease and treatment.
Insomnia Severity Index (ISI) Total Score
Time frame: Baseline, Week 4, and Week 8
This scale is used for routine screening and the clinical assessment of insomnia to identify sleep disturbances. It consists of seven items and two sub-dimensions. It is a 5-point Likert-type scale where each item is scored from 0 to 4, resulting in a total score ranging from 0 to 28. Scores of 0-7 indicate subclinical insomnia, 8-14 indicate mild insomnia, 15-21 indicate moderate insomnia, and 22-28 indicate severe insomnia. The scale's internal consistency is 0.79.
2 secondary outcomes
S³-NIV Respiratory Symptoms Subscale Score
Time frame: Baseline, Week 4, and Week 8
S³-NIV Sleep/NIV-Related Side Effects Subscale Score
Time frame: Baseline, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. The data will be collected by the researcher at the University of Health Sciences Konya Beyhekim Training and Research Hospital.
Related trials for Noninvasive Ventilation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
RecruitingObservational study
Validation of the Turkish Version of the S3-NIV Questionnaire
Respiratory Insufficiency, Chronic Respiratory Failure
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Not yet recruitingObservational study
Predicting the Need for Invasive Mechanical Ventilation Using Different Risk Scores
High Flow Oxygen Therapy, Non Invasive Ventilation (NIV)
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
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. This study is not recruiting at the moment.
Şahabettin ERİŞ, MScN principal investigator
study principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based education in people with Noninvasive Ventilation and COPD, run by KTO Karatay 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S³-NIV Questionnaire Total Score (time frame: Baseline, Week 4, and Week 8). The study lists 2 primary outcomes in all. 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 2 Sep 2026.