Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869071
• Other study ID #: 126/2021
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: Oulu University Hospital
• Contact: Paulus Tokola, MD
• Phone: +35883152011
• Email: paulus.tokola[@]ppshp.fi
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• COPD
• Nasal Polyps
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• Sensor analyzing software (own development)
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
• Body plethysmograph
Body plethysmograph measures specific airway resistance

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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