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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05001464
Enrollment
100
Registered
2021-08-12
Start date
2021-06-01
Completion date
2022-08-31
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Obstructive

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.

Interventions

DEVICEreflectance pulse oximeter

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

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Coincidence rate of total number of oxygen reduction events1 nightThe ratio of the number of oxygen reduction events recorded by reflectance pulse oximeter consistent with PSG to the total oxygen reduction events of PSG

Countries

China

Contacts

Primary ContactHong Li Sun
sunlihong9797@126.com13719240285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026