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

NCT05001464 | Unknown

• 1 other identifier: PP of GIRD
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: reflectance pulse oximeter

Interventions

reflectance pulse oximeter DEVICE

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

Reflectance Pulse Oximeter

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. With the consent of the guardian, children who are scheduled to undergo PSG examination because of suspected OSA. 2. There is no serious dysfunction of heart, lung, liver and kidney. 3. Willing to participate in this project and sign the informed consent form.

You may qualify if:

• Snoring more than 3 nights per week in the last month
• Pediatric sleep questionnaires score ≥ 0.33

You may not qualify if:

• Acute exacerbation of asthma
• Pulmonary infection
• Heart disease

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

151 Yanjiang Road

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jinping Zheng, Professor

  Guangzhou Institute of Respiratory Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Li Sun

CONTACT

13719240285; sunlihong9797@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: August 12, 2021
• Study Start: June 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

CN (1)