Apnea, ObstructiveNCT05001464
Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea
An observational study of Apnea, Obstructive, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- reflectance pulse oximeter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Snoring more than 3 nights per week in the last month
- Pediatric sleep questionnaires score ≥ 0.33
Who cannot join
- Acute exacerbation of asthma
- Pulmonary infection
- Heart disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
151 Yanjiang Road
Guangzhou, Guangdong, 510120
Hong Li Sun, +8613719240285, sunlihong@gird.cn
About this study
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.
Read the 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
- Being tested
- reflectance pulse oximeter
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflectance pulse oximeterDevice
Wearing reflectance pulse oximeter at the same time on the night of PSG examination
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: reflectance pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jun 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
- Investigators
- Jinping Zheng, Professor, Principal investigator, Guangzhou Institute of Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001464
- Sponsor's protocol ID
- PP of GIRD
- Status last verified
- Aug 2021
- First submitted
- 1 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reliability and Validity of Reflectance Pulse Oximeter in Screening Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05001464
- Acronym / sponsor ID
- PP of GIRD
- Conditions
- Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reflectance Pulse Oximeter | – | Device: reflectance pulse oximeterThe 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Snoring more than 3 nights per week in the last month
- Pediatric sleep questionnaires score ≥ 0.33
Key exclusion criteria (3 listed)
- Acute exacerbation of asthma
- Pulmonary infection
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflectance pulse oximeterWearing reflectance pulse oximeter at the same time on the night of PSG examination | Device | Reflectance Pulse Oximeter |
Primary outcome
Coincidence rate of total number of oxygen reduction events
Time frame: 1 night
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinping Zheng, Professor principal investigator
Guangzhou Institute of Respiratory Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Li Sun (13719240285, sunlihong9797@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coincidence rate of total number of oxygen reduction events (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.