Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm
- Conditions
- COPDNasal PolypsAllergic RhinitisAsthma
- Interventions
- Device: Sensor analyzing software (own development)Device: Body plethysmograph
- Registration Number
- NCT05869071
- Lead Sponsor
- Oulu University Hospital
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with COPD Body plethysmograph Participants with Chronic Obstructive Pulmonary Disease Healthy volunteers Body plethysmograph Participants with no chronic disease and no acute symptoms Patients with asthma Sensor analyzing software (own development) Participants with asthma Patients with asthma Body plethysmograph Participants with asthma Patients with Allergic rhinitis or Nasal Polyps Body plethysmograph Participants with allergic rhinitis or nasal polyps Patients with COPD Sensor analyzing software (own development) Participants with Chronic Obstructive Pulmonary Disease Healthy volunteers Sensor analyzing software (own development) Participants with no chronic disease and no acute symptoms Patients with Allergic rhinitis or Nasal Polyps Sensor analyzing software (own development) Participants with allergic rhinitis or nasal polyps
- Primary Outcome Measures
Name Time Method Bias for oral breathing (estimate and 95% confidence intervals) 5 minutes Bias between specific airway resistances given by analyzing software and plethysmograph
Limits of agreement for oral breathing 5 minutes Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
Bias for nasal breathing (estimate and 95% confidence intervals) 5 minutes Bias between specific airway resistance given by analyzing software and plethysmograph
Limits of agreement for nasal breathing 5 minutes Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
- Secondary Outcome Measures
Name Time Method Mean error for oral breathing (estimate and 95% confidence intervals) 5 minutes Mean error between specific airway resistance given by analyzing software and plethysmograph
Correlation between analyzing software and subjective sensation of oral breathing obstruction 5 minutes Correlation between specific airway resistance and graded (6 steps) subjective sensation
Correlation between plethysmograph and subjective sensation of oral breathing obstruction 5 minutes Correlation between specific airway resistance and graded (6 steps) subjective sensation
Correlation between analyzing software and subjective sensation of nasal breathing obstruction 5 minutes Correlation between specific airway resistance and graded (6 steps) subjective sensation
Mean error for nasal breathing (estimate and 95% confidence intervals) 5 minutes Mean error between specific airway resistance given by analyzing software and plethysmograph
Reliability of plethysmograph 5 minutes Measurer's opinion of the reliability of the measurement (4 steps)
Harms of plethysmography 5 minutes Frequency of harmful events related to measurement
Convenience of plethysmography 5 minutes Metrizable's opinion of the convenience (6 steps)
Correlation between plethysmograph and subjective sensation of nasal breathing obstruction 5 minutes Correlation between specific airway resistance and graded (6 steps) subjective sensation
Reliability of analyzing software measurement 5 minutes Measurer's opinion of the reliability of the measurement (4 steps)
Convenience of analyzing software method 5 minutes Metrizable's opinion of the convenience (6 steps)
Harms of analyzing software method 5 minutes Frequency of harmful events related to measurement
Trial Locations
- Locations (1)
Oulu University Hospital
🇫🇮Oulu, Finland