NCT05830227

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

April 14, 2023

Last Update Submit

April 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

-Children ages 2 to 14 with SDB related symptoms

You may qualify if:

  • Children ages 2 to 14 with SDB related symptoms

You may not qualify if:

  • \) Congenital abnormalities of the nose and throat or airway;
  • \) craniofacial deformity
  • \) Neuromuscular dysregulation
  • \) History of adenoids and/or tonsillectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lijun Zeng [lzeng]

Guangdong, Uangdong, 510000, China

RECRUITING

Central Study Contacts

Lijun Z [lzeng], visiting staff

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guangzhou Institute of Respiratory Disease

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 26, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

December 1, 2025

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Observe and study before sharing

Locations