Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea

NCT ID: NCT05001464

Last Updated: 2021-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-08-31

Brief Summary

Polysomnography (PSG) has some disadvantages, such as time-consuming, effort-consuming, long appointment time and high cost. During PSG examination, multiple sensors need to be placed in the patient's head, face, neck, chest and limbs, and sensors are needed to monitor data throughout the night. It is difficult for young children to cooperate, and it is easy to fail due to inaccurate sensor signal acquisition. PSG examination may miss diagnosis or underestimate the disease due to the first night effect. Based on the above reasons, the application of PSG in clinic, especially in pediatric patients is limited. The reflective optical path detection can be used to measure the peripheral blood oxygen saturation in the flat part of human skin. The investigators intend to use a reflectance pulse oximeterto evaluate its reliability and validity in the diagnosis of OSA in children at the same time as PSG.

Detailed Description

During PSG examination, the participants wear reflectance pulse oximeter for continuous monitoring. Use PSG to record EEG, oculogram, chin electromyography, body movement, chest and abdomen movement, nose and mouth airflow, snoring, electrocardiogram, blood oxygen saturation and finger pulse monitoring. The effective monitoring time should be at least 6 hours. Oxygen desaturation index (ODI), average blood oxygen saturation, minimum blood oxygen saturation, percentage of blood oxygen saturation less than 90% in the whole recording time (TS90%), fastest heart rate, slowest heart rate and average heart rate are recorded by reflectance pulse oximeter. To compare the effective time (TST), the total number of hypoxemia events, the coincidence rate of comparing each hypoxemia event, identifying OSA, and identifying moderate and severe OSA by PSG and reflectance pulse oximeter.

Conditions

Apnea, Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Reflectance Pulse Oximeter

The participants wear reflectance pulse oximeter for continuous monitoring when carrying out PSG . Oxygen desaturation index (ODI), average blood oxygen saturation, minimum blood oxygen saturation, percentage of blood oxygen saturation less than 90% in the whole recording time (TS90%), fastest heart rate, slowest heart rate and average heart rate are recorded by reflectance pulse oximeter.

reflectance pulse oximeter

Intervention Type: DEVICE

Wearing reflectance pulse oximeter at the same time on the night of PSG examination

Interventions

reflectance pulse oximeter

Wearing reflectance pulse oximeter at the same time on the night of PSG examination

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Snoring more than 3 nights per week in the last month

2. Pediatric sleep questionnaires score ≥ 0.33

Exclusion Criteria

1. Acute exacerbation of asthma

2. Pulmonary infection

3. Heart disease

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

LI-HONG SUN

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinping Zheng, Professor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Health

Locations

151 Yanjiang Road

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Li Sun

Role: CONTACT

sunlihong9797@126.com

13719240285

Facility Contacts

Hong Li Sun

Role: primary

sunlihong@gird.cn

+8613719240285

Other Identifiers

PP of GIRD

Identifier Type: -

Identifier Source: org_study_id