Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Nasal Polyps Asthma COPD Allergic Rhinitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Body plethysmograph measures specific airway resistance

Intervention Type DEVICE

Other Intervention Names

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Ganshorn PowerCube body+ plethysmograph

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes