Nasal PolypsNCT05869071
Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm
An observational study of Nasal Polyps and Asthma, run by Oulu University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Polyps, Asthma, COPD
- What is being tested?
- Sensor analyzing software (own development) and Body plethysmograph
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 23 May 2023to 30 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, FIN-90029
Paulus Tokola, MD, +358-8-315 2011, Paulus.Tokola@ppshp.fi
Olli-Pekka Alho, +35883152011, olli-pekka.alho@oulu.fi
About this study
Official title: 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.
Read the 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).
- Conditions
- Nasal Polyps, Asthma, COPD, Allergic Rhinitis
- Being tested
- Sensor analyzing software (own development), Body plethysmograph
- Medical subject headings
- Nasal Polyps, Asthma, Pulmonary Disease, Chronic Obstructive, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor analyzing software (own development)Device
A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction.
Body plethysmographDevice
Also called Ganshorn PowerCube body+ plethysmograph
Body plethysmograph measures specific airway resistance
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Participants with no chronic disease and no acute symptoms Receives: Device: Sensor analyzing software (own development); Device: Body plethysmograph | |
| Patients with Allergic rhinitis or Nasal Polyps | Participants with allergic rhinitis or nasal polyps Receives: Device: Sensor analyzing software (own development); Device: Body plethysmograph | |
| Patients with asthma | Participants with asthma Receives: Device: Sensor analyzing software (own development); Device: Body plethysmograph | |
| Patients with COPD | Participants with Chronic Obstructive Pulmonary Disease Receives: Device: Sensor analyzing software (own development); Device: Body plethysmograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bias for oral breathing (estimate and 95% confidence intervals)
Bias between specific airway resistances given by analyzing software and plethysmograph
Measured: 5 minutes
Bias for nasal breathing (estimate and 95% confidence intervals)
Bias between specific airway resistance given by analyzing software and plethysmograph
Measured: 5 minutes
Limits of agreement for oral breathing
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
Measured: 5 minutes
Limits of agreement for nasal breathing
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
Measured: 5 minutes
Secondary outcomes (12)
Mean error for oral breathing (estimate and 95% confidence intervals)
Mean error between specific airway resistance given by analyzing software and plethysmograph
Measured: 5 minutes
Mean error for nasal breathing (estimate and 95% confidence intervals)
Mean error between specific airway resistance given by analyzing software and plethysmograph
Measured: 5 minutes
Correlation between analyzing software and subjective sensation of oral breathing obstruction
Correlation between specific airway resistance and graded (6 steps) subjective sensation
Measured: 5 minutes
Correlation between analyzing software and subjective sensation of nasal breathing obstruction
Correlation between specific airway resistance and graded (6 steps) subjective sensation
Measured: 5 minutes
Correlation between plethysmograph and subjective sensation of oral breathing obstruction
Correlation between specific airway resistance and graded (6 steps) subjective sensation
Measured: 5 minutes
Correlation between plethysmograph and subjective sensation of nasal breathing obstruction
Correlation between specific airway resistance and graded (6 steps) subjective sensation
Measured: 5 minutes
Reliability of analyzing software measurement
Measurer's opinion of the reliability of the measurement (4 steps)
Measured: 5 minutes
Reliability of plethysmograph
Measurer's opinion of the reliability of the measurement (4 steps)
Measured: 5 minutes
Convenience of analyzing software method
Metrizable's opinion of the convenience (6 steps)
Measured: 5 minutes
Convenience of plethysmography
Metrizable's opinion of the convenience (6 steps)
Measured: 5 minutes
Harms of analyzing software method
Frequency of harmful events related to measurement
Measured: 5 minutes
Harms of plethysmography
Frequency of harmful events related to measurement
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start23 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olli-Pekka Alho, MD, Oulu University Hospital
- Investigators
- Olli-Pekka Alho, Prof, Principal investigator, University of Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869071
- Sponsor's protocol ID
- 126/2021
- Status last verified
- Nov 2023
- First submitted
- 11 May 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Accelerometric and Acoustic Signals Utilizing Algorithm and Body Plethysmograph in Detecting Nasal and Oral Specific Airway Resistance
- ClinicalTrials.gov ID
- NCT05869071
- Acronym / sponsor ID
- 126/2021
- Conditions
- Nasal Polyps, Asthma, COPD, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Sensor analyzing software (own development), Device: Body plethysmographParticipants with no chronic disease and no acute symptoms |
| Patients with Allergic rhinitis or Nasal Polyps | – | Device: Sensor analyzing software (own development), Device: Body plethysmographParticipants with allergic rhinitis or nasal polyps |
| Patients with asthma | – | Device: Sensor analyzing software (own development), Device: Body plethysmographParticipants with asthma |
| Patients with COPD | – | Device: Sensor analyzing software (own development), Device: Body plethysmographParticipants with Chronic Obstructive Pulmonary Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensor analyzing software (own development)A software the research group developed. Analyzes acoustic and accelerator signals to measure airway obstruction. | Device | Healthy volunteers, Patients with Allergic rhinitis or Nasal Polyps, Patients with COPD, Patients with asthma |
| Body plethysmographAlso: Ganshorn PowerCube body+ plethysmographBody plethysmograph measures specific airway resistance | Device | Healthy volunteers, Patients with Allergic rhinitis or Nasal Polyps, Patients with COPD, Patients with asthma |
Primary outcome
Bias for oral breathing (estimate and 95% confidence intervals)
Time frame: 5 minutes
Bias between specific airway resistances given by analyzing software and plethysmograph
Bias for nasal breathing (estimate and 95% confidence intervals)
Time frame: 5 minutes
Bias between specific airway resistance given by analyzing software and plethysmograph
Limits of agreement for oral breathing
Time frame: 5 minutes
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
Limits of agreement for nasal breathing
Time frame: 5 minutes
Limits of agreement between specific airway resistance given by analyzing software and plethysmograph
12 secondary outcomes
Mean error for oral breathing (estimate and 95% confidence intervals)
Time frame: 5 minutes
Mean error for nasal breathing (estimate and 95% confidence intervals)
Time frame: 5 minutes
Correlation between analyzing software and subjective sensation of oral breathing obstruction
Time frame: 5 minutes
Correlation between analyzing software and subjective sensation of nasal breathing obstruction
Time frame: 5 minutes
Correlation between plethysmograph and subjective sensation of oral breathing obstruction
Time frame: 5 minutes
Correlation between plethysmograph and subjective sensation of nasal breathing obstruction
Time frame: 5 minutes
Reliability of analyzing software measurement
Time frame: 5 minutes
Reliability of plethysmograph
Time frame: 5 minutes
Convenience of analyzing software method
Time frame: 5 minutes
Convenience of plethysmography
Time frame: 5 minutes
Harms of analyzing software method
Time frame: 5 minutes
Harms of plethysmography
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olli-Pekka Alho, Prof principal investigator
University of Oulu, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Polyps and Asthma, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulus Tokola, MD (+35883152011, paulus.tokola@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bias for oral breathing (estimate and 95% confidence intervals) (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.