Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

Oulu University Hospital

Status: Enrolling

Conditions: Asthma; Allergic Rhinitis; Nasal Polyps; COPD

Treatments: Device: Sensor analyzing software (own development); Device: Body plethysmograph

Study type: Observational

Funder types: Other

Identifiers

NCT05869071

126/2021

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 4 patient groups

Healthy volunteers

Description:

Participants with no chronic disease and no acute symptoms

Treatment:

Device: Sensor analyzing software (own development)

Device: Body plethysmograph

Patients with Allergic rhinitis or Nasal Polyps

Description:

Participants with allergic rhinitis or nasal polyps

Treatment:

Device: Sensor analyzing software (own development)

Device: Body plethysmograph

Patients with asthma

Description:

Participants with asthma

Treatment:

Device: Sensor analyzing software (own development)

Device: Body plethysmograph

Patients with COPD

Description:

Participants with Chronic Obstructive Pulmonary Disease

Treatment:

Device: Sensor analyzing software (own development)

Device: Body plethysmograph