Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

Sponsor
Oulu University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05869071
Collaborator
(none)
20
1
4.3
4.7

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Sensor analyzing software (own development)
  • Device: Body plethysmograph

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Agreement Between Accelerometric and Acoustic Signals Utilizing Algorithm and Body Plethysmograph in Detecting Nasal and Oral Specific Airway Resistance
Actual Study Start Date :
May 23, 2023
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Bias for oral breathing (estimate and 95% confidence intervals) [5 minutes]

      Bias between specific airway resistances given by analyzing software and plethysmograph

    2. Bias for nasal breathing (estimate and 95% confidence intervals) [5 minutes]

      Bias between specific airway resistance given by analyzing software and plethysmograph

    3. Limits of agreement for oral breathing [5 minutes]

      Limits of agreement between specific airway resistance given by analyzing software and plethysmograph

    4. Limits of agreement for nasal breathing [5 minutes]

      Limits of agreement between specific airway resistance given by analyzing software and plethysmograph

    Secondary Outcome Measures

    1. Mean error for oral breathing (estimate and 95% confidence intervals) [5 minutes]

      Mean error between specific airway resistance given by analyzing software and plethysmograph

    2. Mean error for nasal breathing (estimate and 95% confidence intervals) [5 minutes]

      Mean error between specific airway resistance given by analyzing software and plethysmograph

    3. Correlation between analyzing software and subjective sensation of oral breathing obstruction [5 minutes]

      Correlation between specific airway resistance and graded (6 steps) subjective sensation

    4. Correlation between analyzing software and subjective sensation of nasal breathing obstruction [5 minutes]

      Correlation between specific airway resistance and graded (6 steps) subjective sensation

    5. Correlation between plethysmograph and subjective sensation of oral breathing obstruction [5 minutes]

      Correlation between specific airway resistance and graded (6 steps) subjective sensation

    6. Correlation between plethysmograph and subjective sensation of nasal breathing obstruction [5 minutes]

      Correlation between specific airway resistance and graded (6 steps) subjective sensation

    7. Reliability of analyzing software measurement [5 minutes]

      Measurer's opinion of the reliability of the measurement (4 steps)

    8. Reliability of plethysmograph [5 minutes]

      Measurer's opinion of the reliability of the measurement (4 steps)

    9. Convenience of analyzing software method [5 minutes]

      Metrizable's opinion of the convenience (6 steps)

    10. Convenience of plethysmography [5 minutes]

      Metrizable's opinion of the convenience (6 steps)

    11. Harms of analyzing software method [5 minutes]

      Frequency of harmful events related to measurement

    12. Harms of plethysmography [5 minutes]

      Frequency of harmful events related to measurement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oulu University Hospital Oulu Finland FIN-90029

    Sponsors and Collaborators

    • Oulu University Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olli-Pekka Alho, MD, Professor, Oulu University Hospital
    ClinicalTrials.gov Identifier:
    NCT05869071
    Other Study ID Numbers:
    • 126/2021
    First Posted:
    May 22, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2023