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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy volunteers
Participants with no chronic disease and no acute symptoms
Device: Sensor analyzing software (own development)
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Device: Body plethysmograph
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
Device: Sensor analyzing software (own development)
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Device: Body plethysmograph
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph
Patients with asthma
Participants with asthma
Device: Sensor analyzing software (own development)
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Device: Body plethysmograph
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph
Patients with COPD
Participants with Chronic Obstructive Pulmonary Disease
Device: Sensor analyzing software (own development)
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Device: Body plethysmograph
Body plethysmograph measures specific airway resistance
Other Names:
  • Ganshorn PowerCube body+ plethysmograph

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oulu University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 126/2021

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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