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

Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001464
• Other study ID #: PP of GIRD
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2021
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Hong Li Sun
• Phone: 13719240285
• Email: sunlihong9797[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Apnea, Obstructive
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
China	151 Yanjiang Road	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coincidence rate of total number of oxygen reduction events	The ratio of the number of oxygen reduction events recorded by reflectance pulse oximeter consistent with PSG to the total oxygen reduction events of PSG	1 night