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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Participants with no chronic disease and no acute symptoms |
| |
| Patients with Allergic rhinitis or Nasal Polyps | Participants with allergic rhinitis or nasal polyps |
| |
| Patients with asthma | Participants with asthma |
| |
| Patients with COPD | Participants with Chronic Obstructive Pulmonary Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor analyzing software (own development) | Device | A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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The healthy volunteers are selected from the personnel or students of Oulu University Hospital and University of Oulu. The patients with allergic rhinitis and nasal polyps, asthma and Chronic Obstructive Pulmonary Disease are selected from the Oulu University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paulus Tokola, MD | Contact | +35883152011 | paulus.tokola@ppshp.fi | |
| Olli-Pekka Alho, Prof | Contact | +35883152011 | olli-pekka.alho@oulu.fi |
| Name | Affiliation | Role |
|---|---|---|
| Olli-Pekka Alho, Prof | University of Oulu, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu University Hospital | Recruiting | Oulu | FIN-90029 | Finland |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| Body plethysmograph | Device | Body plethysmograph measures specific airway resistance |
|
|
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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D012220 | Rhinitis |