Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

November 6, 2023 updated by: Olli-Pekka Alho, MD, Oulu University Hospital

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

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.

Study Overview

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).

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Oulu, Finland, FIN-90029
        • Recruiting
        • Oulu University Hospital
        • Sub-Investigator:
          • Paulus Tokola, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Participants with no chronic disease and no acute symptoms
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph
Patients with Allergic rhinitis or Nasal Polyps
Participants with allergic rhinitis or nasal polyps
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph
Patients with asthma
Participants with asthma
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph
Patients with COPD
Participants with Chronic Obstructive Pulmonary Disease
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bias for oral breathing (estimate and 95% confidence intervals)
Time Frame: 5 minutes
Bias between specific airway resistances given by analyzing software and plethysmograph
5 minutes
Bias for nasal breathing (estimate and 95% confidence intervals)
Time Frame: 5 minutes
Bias between specific airway resistance given by analyzing software and plethysmograph
5 minutes
Limits of agreement for oral breathing
Time Frame: 5 minutes
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
5 minutes
Limits of agreement for nasal breathing
Time Frame: 5 minutes
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olli-Pekka Alho, Prof, University of Oulu, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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