Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children

Sponsor
State Key Laboratory of Respiratory Disease (Other)
Overall Status
Recruiting
CT.gov ID
NCT05830227
Collaborator
(none)
80
1
32
2.5

Study Details

Study Description

Brief Summary

OSAHS is a common sleep breathing disorder in children, with the same incidence as childhood asthma, and is mainly caused by upper airway stenosis caused by tonsil/adenoid hyperplasia. Clinical findings show that children with OSAHS often present rhinitis symptoms and like rubbing eyes, but there is no evidence to suggest a correlation. Children with OSAHS suffer from recurrent hypoxemia during sleep, and the existing detection methods such as lateral nasopharyngeal radiographs and electronic nasopharyngoscopy can only reflect the structural and morphological changes of the oral, nasal and pharyngeal tissues, but cannot prove their functional status. Previous studies have found that infrared thermal imaging can reflect the oral, nasal and pharyngeal inflammation of patients, and the infrared expression of patients' frontal region and eyes can also reflect the physiological changes caused by sleep deprivation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this project, the children were divided into four groups: primary snoring, critical OSAHS, mild OSAHS and moderate to severe OSAHS, and the tests were completed, including lateral nasopharyngeal radiographs, infrared detection of oropharynx and pharynx, infrared detection of frontal area and eye area, intelligence and behavior scale assessment, etc. Furthermore, the correlation between infrared detection and obstructive sleep apnea hypopnea index, peripheral blood oxygen saturation, adenoid hyperplasia degree of nasopharyngeal lateral film as parameters were analyzed, and the sensitivity and specificity of infrared detection was determined to confirm the diagnostic value of OSAHS. It provides a theoretical basis for finding a convenient, non-damaging, non-radiation, visual and suitable for children functional image detection method.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Infrared Thermal Imaging in Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome in Children
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Primary snoring group

    Primary snoring group

    Critical OSAHS group

    Critical OSAHS group

    Mild OSAHS group

    Mild OSAHS group

    Moderate to severe OSAHS group

    Moderate to severe OSAHS group

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity [2025]

      Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity (sleep breathing parameters OAHI and LSpO2)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Children ages 2 to 14 with SDB related symptoms
    Exclusion Criteria:
      1. Congenital abnormalities of the nose and throat or airway;
    1. craniofacial deformity

    2. Neuromuscular dysregulation

    3. History of adenoids and/or tonsillectomy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lijun Zeng [lzeng] Guangdong Uangdong China 510000

    Sponsors and Collaborators

    • State Key Laboratory of Respiratory Disease

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lijun Zeng, Guangzhou Institute of Respiratory Disease, Guangzhou Institute of Respiratory Disease
    ClinicalTrials.gov Identifier:
    NCT05830227
    Other Study ID Numbers:
    • GuangzhouIRD
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    Apr 26, 2023
    Last Verified:
    Apr 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

    Study Results

    No Results Posted as of Apr 26, 2023