Clinical trial NCT05869071: Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm
Official title: Agreement Between Accelerometric and Acoustic Signals Utilizing Algorithm and Body Plethysmograph in Detecting Nasal and Oral Specific Airway Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Polyps
Asthma
COPD
Allergic Rhinitis
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Bias for oral breathing (estimate and 95% confidence intervals)
timeFrame: 5 minutes
measure: Bias for nasal breathing (estimate and 95% confidence intervals)
timeFrame: 5 minutes
measure: Limits of agreement for oral breathing
timeFrame: 5 minutes
measure: Limits of agreement for nasal breathing
timeFrame: 5 minutes
Secondary outcomes:
measure: Mean error for oral breathing (estimate and 95% confidence intervals)
timeFrame: 5 minutes
measure: Mean error for nasal breathing (estimate and 95% confidence intervals)
timeFrame: 5 minutes
measure: Correlation between analyzing software and subjective sensation of oral breathing obstruction
timeFrame: 5 minutes
measure: Correlation between analyzing software and subjective sensation of nasal breathing obstruction
timeFrame: 5 minutes
measure: Correlation between plethysmograph and subjective sensation of oral breathing obstruction
timeFrame: 5 minutes
measure: Correlation between plethysmograph and subjective sensation of nasal breathing obstruction
timeFrame: 5 minutes
measure: Reliability of analyzing software measurement
timeFrame: 5 minutes
measure: Reliability of plethysmograph
timeFrame: 5 minutes
measure: Convenience of analyzing software method
timeFrame: 5 minutes
measure: Convenience of plethysmography
timeFrame: 5 minutes
measure: Harms of analyzing software method
timeFrame: 5 minutes
measure: Harms of plethysmography
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu, Finland
name: Olli-Pekka Alho, Prof
role: PRINCIPAL_INVESTIGATOR
References: