- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05869071
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
Recruiting
Conditions
Intervention / Treatment
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
- Name: Paulus Tokola, MD
- Phone Number: +35883152011
- Email: paulus.tokola@ppshp.fi
Study Contact Backup
- Name: Olli-Pekka Alho, Prof
- Phone Number: +35883152011
- Email: olli-pekka.alho@oulu.fi
Study Locations
-
-
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Oulu, Finland, FIN-90029
- Recruiting
- Oulu University Hospital
-
Sub-Investigator:
- Paulus Tokola, MD
-
Contact:
- Paulus Tokola, MD
- Phone Number: +358-8-315 2011
- Email: Paulus.Tokola@ppshp.fi
-
Contact:
- Olli-Pekka Alho
- Phone Number: +35883152011
- Email: olli-pekka.alho@oulu.fi
-
-
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:
|
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:
|
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:
|
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:
|
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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