Clinical trial NCT05001464: Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea
Official title: Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apnea, Obstructive
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Coincidence rate of total number of oxygen reduction events
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 151 Yanjiang Road
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Health
name: Jinping Zheng, Professor
role: PRINCIPAL_INVESTIGATOR
References: