Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children

Evaluation of Infrared Thermal Imaging in Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Infrared-thermal-imaging

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Lijun Z [lzeng], visiting staff; Phone Number: Lijun Zeng 13450360939; Email: 865391757@qq.com

Study Locations

• China
  • Uangdong
    • Guangdong, Uangdong, China, 510000
      • Recruiting
      • Lijun Zeng [lzeng]
      • Contact: Lijun Z [lzeng]; Phone Number: Lijun Zeng 13450360939; Email: 865391757@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

-Children ages 2 to 14 with SDB related symptoms

Description

Inclusion Criteria:

• Children ages 2 to 14 with SDB related symptoms

Exclusion Criteria:

• 1) Congenital abnormalities of the nose and throat or airway;

  2) craniofacial deformity

  3) Neuromuscular dysregulation

  4) History of adenoids and/or tonsillectomy.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Primary snoring group
Critical OSAHS group
Mild OSAHS group
Moderate to severe OSAHS group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity	Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity (sleep breathing parameters OAHI and LSpO2)	2025

Collaborators and Investigators

• Sponsor: State Key Laboratory of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GuangzhouIRD (GuangzhouIRD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Observe and study before sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No