Obstructive Sleep ApneaNCT05634096
Oximetry in Children for Sleep Apnea Diagnosis
An observational study of Obstructive Sleep Apnea, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oximetry
- How many people
- 950 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 15 Jan 2023
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022. Data of vP(S)G and of oximetry are retrospectively collected from the hospital recording of children who underwent these exams.
Who may be able to join
- Children aged 2 to 18 years suspected of OSA who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022.
Who cannot join
- Children with non-interpretable recordings
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
Iulia Ioan, MD PhD, +33383154794, ic.ioan@chru-nancy.fr
About this study
Official title: Oximetry for Diagnosis of Obstructive Sleep Apnea Syndrome in Children
Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. This exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. Portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify a moderate-severe OSAS in children.
Read the detailed description
Video-polysomnography (vPSG) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children. The vPSG gives the obstructive apnea-hypopnea index (OAHI), necessary for the diagnosis of OSAS and to determine its severity. But the vPSG is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. Video-respiratory polygraphy (vPG) is very similar to vPSG but without EEG, EOG and EMG electrodes. vPG represents an alternative for the diagnosis of OSAS. However, these sleep examinations, vP(S)G, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization.
The desaturation index obtained by simple portable oximetry could be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. Portable oximetry is an easier test to perform. It is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital.
The coupling of these 2 examinations, vP(S)G and oximetry, is part of our current routine practice. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify an OSAS in children.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Oximetry
- Keywords
- Sleep, Child, Polysomnography, Polygraphy
- 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.
OximetryDiagnostic test
Children underwent oximetry simultaneously with video-polygraphy or video-polysomnography in routine clinical practice. The data are retrospectively collected from the patient's recording.
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation index is different in moderate-severe OSAS
The number of desaturations per hour of recording obtained by oximetry between children with moderate-severe OSAS (defined as OAHI ≥ 5/h of sleep on the vP(S)G) and children without OSAS/with mild OSAS (defined as OAHI < 5/h of sleep )
Measured: Baseline
Secondary outcomes (1)
Sensitivity and specificity of desaturation index
Sensitivity and specificity of the number of desaturations per hour if recording obtained by oximetry alone for the identification of children with moderate-severe OSAS (defined as an OAHI ≥ 5 /h of sleep in vP(S)G).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start2 Jan 2023 (estimated)
- Primary completion3 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Iulia IOAN, Central Hospital, Nancy, France
- Investigators
- Iulia IOAN, MD PhD, Principal investigator, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634096
- Sponsor's protocol ID
- 2022PI161-318
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaditis A, Kheirandish-Gozal L, Gozal D. Pediatric OSAS: Oximetry can provide answers when polysomnography is not available. Sleep Med Rev. 2016 Jun;27:96-105. doi: 10.1016/j.smrv.2015.05.008. Epub 2015 Jun 4.
PubMed 26146027Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
PubMed 22926173Van Eyck A, Lambrechts C, Vanheeswijck L, Van Hoorenbeeck K, Haentjens D, Boudewyns A, De Winter BY, Van Gaal L, De Backer W, Verhulst SL. The role of nocturnal pulse oximetry in the screening for obstructive sleep apnea in obese children and adolescents. Sleep Med. 2015 Nov;16(11):1409-1412. doi: 10.1016/j.sleep.2015.07.023. Epub 2015 Aug 18.
PubMed 26498244Trucco F, Rosenthal M, Bush A, Tan HL. The McGill score as a screening test for obstructive sleep disordered breathing in children with co-morbidities. Sleep Med. 2020 Apr;68:173-176. doi: 10.1016/j.sleep.2019.12.010. Epub 2019 Dec 28.
PubMed 32044554
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oximetry for Diagnosis of Obstructive Sleep Apnea Syndrome in Children
- ClinicalTrials.gov ID
- NCT05634096
- Acronym / sponsor ID
- 2022PI161-318
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep, Child, Polysomnography, Polygraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 3 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 1 Dec 2022 (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.
Video-polygraphy or video-polysomnography (vP(S)G) is the reference exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children as it allows the detection of the respiratory events presented by the child during sleep. This exam requires a one-night hospitalization and several sensors installed on the child's body, sometimes not well-accepted in children. Portable oximetry is an easier test to perform, better accepted by the child, and gives the desaturation index that may be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify a moderate-severe OSAS in children.
Detailed description
Video-polysomnography (vPSG) with video surveillance and monitoring by a nurse to reposition the sensors if needed during the night is the gold standard exam for the diagnosis of obstructive sleep apnea syndrome (OSAS) in children. The vPSG gives the obstructive apnea-hypopnea index (OAHI), necessary for the diagnosis of OSAS and to determine its severity. But the vPSG is a rather cumbersome exam, sometimes difficult to perform in children, with several sensors and electrodes to install on a child's body (electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), nasal cannula, thoracoabdominal belts, pulse oximetry, body position) that is time-consuming for installation and analysis. Video-respiratory polygraphy (vPG) is very similar to vPSG but without EEG, EOG and EMG electrodes. vPG represents an alternative for the diagnosis of OSAS. However, these sleep examinations, vP(S)G, requires a number of electrodes and sensors to be installed on the child's body and one night of hospitalization.
The desaturation index obtained by simple portable oximetry could be used for the diagnosis of OSAS because most respiratory events are associated with desaturations. Portable oximetry is an easier test to perform. It is better accepted by the child because it only requires a finger or toe sensor and could be done on an outpatient basis or in the hospital.
The coupling of these 2 examinations, vP(S)G and oximetry, is part of our current routine practice. The hypothesis of this study is that the desaturation index obtained by the oximetry performed at the same time with the v(P(S)G) can identify an OSAS in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022. Data of vP(S)G and of oximetry are retrospectively collected from the hospital recording of children who underwent these exams.
Key inclusion criteria (1 listed)
- Children aged 2 to 18 years suspected of OSA who underwent a vP(S)G simultaneously with oximetry during the period June 2017 to June 2022.
Key exclusion criteria (1 listed)
- Children with non-interpretable recordings
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 |
|---|---|---|
| OximetryChildren underwent oximetry simultaneously with video-polygraphy or video-polysomnography in routine clinical practice. The data are retrospectively collected from the patient's recording. | Diagnostic test | – |
Primary outcome
Desaturation index is different in moderate-severe OSAS
Time frame: Baseline
The number of desaturations per hour of recording obtained by oximetry between children with moderate-severe OSAS (defined as OAHI ≥ 5/h of sleep on the vP(S)G) and children without OSAS/with mild OSAS (defined as OAHI < 5/h of sleep )
1 secondary outcome
Sensitivity and specificity of desaturation index
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Background: PubMed 26146027Kaditis A, Kheirandish-Gozal L, Gozal D. Pediatric OSAS: Oximetry can provide answers when polysomnography is not available. Sleep Med Rev. 2016 Jun;27:96-105. doi: 10.1016/j.smrv.2015.05.008. Epub 2015 Jun 4.
- Background: PubMed 22926173Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
- Background: PubMed 26498244Van Eyck A, Lambrechts C, Vanheeswijck L, Van Hoorenbeeck K, Haentjens D, Boudewyns A, De Winter BY, Van Gaal L, De Backer W, Verhulst SL. The role of nocturnal pulse oximetry in the screening for obstructive sleep apnea in obese children and adolescents. Sleep Med. 2015 Nov;16(11):1409-1412. doi: 10.1016/j.sleep.2015.07.023. Epub 2015 Aug 18.
- Background: PubMed 32044554Trucco F, Rosenthal M, Bush A, Tan HL. The McGill score as a screening test for obstructive sleep disordered breathing in children with co-morbidities. Sleep Med. 2020 Apr;68:173-176. doi: 10.1016/j.sleep.2019.12.010. Epub 2019 Dec 28.
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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.
Iulia IOAN, MD PhD principal investigator
CHRU de Nancy
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 Obstructive Sleep Apnea, run by Central Hospital, Nancy, France at 1 site in France.
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 1 inclusion and 1 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 3 Jan 2023. 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 France. 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 Iulia IOAN, MD PhD (+33383154794, ic.ioan@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation index is different in moderate-severe OSAS (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634096, which also lists 4 linked publications.
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 3 Jan 2023.