Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the agreement between sensors analyzing algorithm and body plethysmography in measuring oral and nasal breathing in healthy adults, and in patients with chronic rhinosinusitis, asthma and chronic obstructive pulmonary disease. The main question it aims to answer is: • Is the algorithm-based method accurate enough in analyzing respiratory obstruction as compared to body plethysmography (reference method)? Participants will perform a short breathing protocol (oral and nasal breathing with different masks) during which time their breathing is monitored with both methods.

Detailed Description
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The data collected in the Patient Registry include: Parameters on general health, like previous illnesses, medications, height, weight, answers to symptoms queries and queries on quality of life (Asthma test, COPD test, Sinonasal Outcome Test 22) as well as results from the examined medical devices (body plethysmography, spirometry, sensors analyzing algorithm).

Official Title
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Agreement Between Accelerometric and Acoustic Signals Utilizing Algorithm and Body Plethysmograph in Detecting Nasal and Oral Specific Airway Resistance

Conditions
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Nasal Polyps, Asthma, COPD, Allergic Rhinitis

Intervention / Treatment
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* Device: Sensor analyzing software (own development)
* Device: Body plethysmograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5 healthy and asymptomatic volunteers with regard to lungs and nose 5 patients with allergic rhinitis or nasal polyps (diagnosis of allergic rhinitis confirmed by a PRICK test or specific Ig E antibody tests and Nasal polyposis diagnosed by an ENT specialist, with endoscopy) 5 patients with asthma (diagnosis of asthma based on peak expiratory flow (PEF) monitoring, spirometry, or other appropriate objective measurement methods performed by a pulmonologist 5 patients with Chronic Obstructive Pumonary Disease (diagnosis of COPD based on spirometry (post-bronchodilator Forced Expiratory Volume/ Forced Vital Capacity (FEV1/FVC) ratio below 0.70) Exclusion Criteria: Pregnancy. History of surgical procedures in the chest, larynx, throat (excluding tonsillectomy), or nasal area. Recent illnesses or surgeries that pose a risk to the patient or prevent proper measurement (common contraindications for spirometry): Recent (<1 month) myocardial infarction. Severe coronary artery disease with easily triggered symptoms. Cerebral artery aneurysm. Recent brain (<4 weeks) or eye (<1 week) surgery. Severe cardiac arrhythmias. Pulmonary tuberculosis. Pneumothorax Immediate postoperative period of lung surgery (<1 day). Dementia or confusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>Participants with no chronic disease and no acute symptoms | Device: Sensor analyzing software (own development)<br>* A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.<br>Device: Body plethysmograph<br>* Body plethysmograph measures specific airway resistance<br>* Other names: Ganshorn PowerCube body+ plethysmograph;|
| Patients with Allergic rhinitis or Nasal Polyps<br>Participants with allergic rhinitis or nasal polyps | Device: Sensor analyzing software (own development)<br>* A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.<br>Device: Body plethysmograph<br>* Body plethysmograph measures specific airway resistance<br>* Other names: Ganshorn PowerCube body+ plethysmograph;|
| Patients with asthma<br>Participants with asthma | Device: Sensor analyzing software (own development)<br>* A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.<br>Device: Body plethysmograph<br>* Body plethysmograph measures specific airway resistance<br>* Other names: Ganshorn PowerCube body+ plethysmograph;|
| Patients with COPD<br>Participants with Chronic Obstructive Pulmonary Disease | Device: Sensor analyzing software (own development)<br>* A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.<br>Device: Body plethysmograph<br>* Body plethysmograph measures specific airway resistance<br>* Other names: Ganshorn PowerCube body+ plethysmograph;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias for oral breathing (estimate and 95% confidence intervals) | Bias between specific airway resistances given by analyzing software and plethysmograph | 5 minutes | 
| Bias for nasal breathing (estimate and 95% confidence intervals) | Bias between specific airway resistance given by analyzing software and plethysmograph | 5 minutes | 
| Limits of agreement for oral breathing | Limits of agreement between specific airway resistance given by analyzing software and plethysmograph | 5 minutes | 
| Limits of agreement for nasal breathing | Limits of agreement between specific airway resistance given by analyzing software and plethysmograph | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean error for oral breathing (estimate and 95% confidence intervals) | Mean error between specific airway resistance given by analyzing software and plethysmograph | 5 minutes | 
| Mean error for nasal breathing (estimate and 95% confidence intervals) | Mean error between specific airway resistance given by analyzing software and plethysmograph | 5 minutes | 
| Correlation between analyzing software and subjective sensation of oral breathing obstruction | Correlation between specific airway resistance and graded (6 steps) subjective sensation | 5 minutes | 
| Correlation between analyzing software and subjective sensation of nasal breathing obstruction | Correlation between specific airway resistance and graded (6 steps) subjective sensation | 5 minutes | 
| Correlation between plethysmograph and subjective sensation of oral breathing obstruction | Correlation between specific airway resistance and graded (6 steps) subjective sensation | 5 minutes | 
| Correlation between plethysmograph and subjective sensation of nasal breathing obstruction | Correlation between specific airway resistance and graded (6 steps) subjective sensation | 5 minutes | 
| Reliability of analyzing software measurement | Measurer's opinion of the reliability of the measurement (4 steps) | 5 minutes | 
| Reliability of plethysmograph | Measurer's opinion of the reliability of the measurement (4 steps) | 5 minutes | 
| Convenience of analyzing software method | Metrizable's opinion of the convenience (6 steps) | 5 minutes | 
| Convenience of plethysmography | Metrizable's opinion of the convenience (6 steps) | 5 minutes | 
| Harms of analyzing software method | Frequency of harmful events related to measurement | 5 minutes | 
| Harms of plethysmography | Frequency of harmful events related to measurement | 5 minutes |