Apnea, Obstructive SleepNCT05575921
Diagnostic of Sleep Obstructive Apnea Syndrome in Children
An observational study of Apnea, Obstructive Sleep, run by Central Hospital, Nancy, France.
Trial summary
Obstructive Sleep Apnea Syndrome (OSAS) in children is a significant public health problem whose clinical diagnosis is not specific. The recording of sleep and breathing (polysomnography, PSG) is the reference exam. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Apnea, Obstructive Sleep
- What is being tested?
- Polysomnography
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 30 Oct 2022
- 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
- Child, Adult
Study population: Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021
Who may be able to join
- Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic of Sleep Obstructive Apnea Syndrome in Children by Home Sleep Studies
Obstructive Sleep Apnea Syndrome (OSAS) in children is a significant public health problem whose clinical diagnosis is not specific. The recording of sleep and breathing (polysomnography, PSG) is the reference exam. PSG consists in installing on the child's body electrodes necessary to determine the sleep stages and sensors used to determine the presence of respiratory events during sleep. At-home PSG, compared to hospital PSG, improves sleep quality. PSG is yet an anxious exam due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only respiratory detectors.
The objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG.
Read the detailed description
Obstructive Sleep Apnea Syndrome (OSAS) in children causes chronic hematosis disorders and sleep disruption that negatively impacts growth, neurocognitive performance, and cardiovascular and metabolic functions. Its high frequency makes it a major public health problem. The clinical elements for the diagnosis are not specific and the recording of sleep and breathing (polysomnography, PSG) is the reference exam (HAS Recommendations, 2012). PSG consists in installing on a child's body electroencephalogram (EEG), electrooculogram (EOG), and electromyogram (EMG) electrodes, necessary to determine the sleep stages and sleep-wake periods, and also the sensors used to determine the presence of respiratory events during sleep such as a nasal cannula, thoracoabdominal belts, oximetry, and actimetry. At-home PSG, compared to hospital PSG, improves sleep quality and diagnostic conditions. But the PSG remains a rather anxious exam for the child due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only the respiratory detectors (nasal cannula, thoracoabdominal belts, oximetry, and actimetry), without the EEG, EOG, and EMG electrodes. Several studies in the literature have compared these 2 exams, PSG and PG, for diagnosing OSAS in children with varied and sometimes contradictory results.
The hypothesis of the study is that the obstructive apnea-hypopnea index (OAHI, the number of apneas, and obstructive hypopneas per hour) obtained by at-home PSG and the OAHI obtained by at-home PG are not different. For this, the sleep physician will analyze the sleep recording performed at home in routine clinical practice, in 2 ways: 1) by determining the sleep stages and computing OAHI per hour of sleep; 2) by removing EEG, EOG, and EMG signals and computing OAHI over the duration of the sleep estimated by the physician according to child's behavior during sleep (movements, artifacts) as in PG.
The main objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG, i.e. OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG. The second objective is to determine the faisability in terms of the percentage of interpretable exams of at-home PSG.
- Conditions
- Apnea, Obstructive Sleep
- Being tested
- Polysomnography
- Keywords
- Sleep apnea, Child, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Children underwent at-home polysomnography in routine clinical practice. The exam is interpreted in 2 ways by the physician with sleep stages (PSG) and without sleep stages (PG). 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.
At-home PG has the same diagnostic value than at-home PSG
OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG
Measured: One night
Secondary outcomes (1)
At-home PSG faisability
To determine the faisability in terms of the percentage of interpretable exam for at-home PSG
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Oct 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Apnea, Obstructive SleepStudies 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
- 44 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575921
- Sponsor's protocol ID
- 2022PI145-309
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marcus 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 22926173Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
PubMed 16735907Masoud AI, Patwari PP, Adavadkar PA, Arantes H, Park C, Carley DW. Validation of the MediByte Portable Monitor for the Diagnosis of Sleep Apnea in Pediatric Patients. J Clin Sleep Med. 2019 May 15;15(5):733-742. doi: 10.5664/jcsm.7764.
PubMed 31053204Lesser DJ, Haddad GG, Bush RA, Pian MS. The utility of a portable recording device for screening of obstructive sleep apnea in obese adolescents. J Clin Sleep Med. 2012 Jun 15;8(3):271-7. doi: 10.5664/jcsm.1912.
PubMed 22701384Massicotte C, Al-Saleh S, Witmans M, Narang I. The utility of a portable sleep monitor to diagnose sleep-disordered breathing in a pediatric population. Can Respir J. 2014 Jan-Feb;21(1):31-5. doi: 10.1155/2014/271061. Epub 2013 Sep 30.
PubMed 24083303
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic of Sleep Obstructive Apnea Syndrome in Children by Home Sleep Studies
- ClinicalTrials.gov ID
- NCT05575921
- Acronym / sponsor ID
- 2022PI145-309
- Conditions
- Apnea, Obstructive Sleep
- Keywords
- Sleep apnea, Child, Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 12 Oct 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.
Obstructive Sleep Apnea Syndrome (OSAS) in children is a significant public health problem whose clinical diagnosis is not specific. The recording of sleep and breathing (polysomnography, PSG) is the reference exam. PSG consists in installing on the child's body electrodes necessary to determine the sleep stages and sensors used to determine the presence of respiratory events during sleep. At-home PSG, compared to hospital PSG, improves sleep quality. PSG is yet an anxious exam due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only respiratory detectors.
The objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG.
Detailed description
Obstructive Sleep Apnea Syndrome (OSAS) in children causes chronic hematosis disorders and sleep disruption that negatively impacts growth, neurocognitive performance, and cardiovascular and metabolic functions. Its high frequency makes it a major public health problem. The clinical elements for the diagnosis are not specific and the recording of sleep and breathing (polysomnography, PSG) is the reference exam (HAS Recommendations, 2012). PSG consists in installing on a child's body electroencephalogram (EEG), electrooculogram (EOG), and electromyogram (EMG) electrodes, necessary to determine the sleep stages and sleep-wake periods, and also the sensors used to determine the presence of respiratory events during sleep such as a nasal cannula, thoracoabdominal belts, oximetry, and actimetry. At-home PSG, compared to hospital PSG, improves sleep quality and diagnostic conditions. But the PSG remains a rather anxious exam for the child due to the multitude of electrodes and sensors. Ventilatory polygraphy (PG) consists of installing only the respiratory detectors (nasal cannula, thoracoabdominal belts, oximetry, and actimetry), without the EEG, EOG, and EMG electrodes. Several studies in the literature have compared these 2 exams, PSG and PG, for diagnosing OSAS in children with varied and sometimes contradictory results.
The hypothesis of the study is that the obstructive apnea-hypopnea index (OAHI, the number of apneas, and obstructive hypopneas per hour) obtained by at-home PSG and the OAHI obtained by at-home PG are not different. For this, the sleep physician will analyze the sleep recording performed at home in routine clinical practice, in 2 ways: 1) by determining the sleep stages and computing OAHI per hour of sleep; 2) by removing EEG, EOG, and EMG signals and computing OAHI over the duration of the sleep estimated by the physician according to child's behavior during sleep (movements, artifacts) as in PG.
The main objective of this study is to demonstrate that at-home PG has the same diagnostic value as at-home PSG, i.e. OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG. The second objective is to determine the faisability in terms of the percentage of interpretable exams of at-home PSG.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021
Key inclusion criteria (1 listed)
- Data from at-home PSG retrospectively collected from the hospital recording of children who underwent an exam during the period October 2020 to March 2021
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PolysomnographyChildren underwent at-home polysomnography in routine clinical practice. The exam is interpreted in 2 ways by the physician with sleep stages (PSG) and without sleep stages (PG). The data are retrospectively collected from the patient's recording | Diagnostic test | – |
Primary outcome
At-home PG has the same diagnostic value than at-home PSG
Time frame: One night
OAHI obtained by at-home PG is similar to OAHI obtained by at-home PSG
1 secondary outcome
At-home PSG faisability
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Results publication: 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.
- Results publication: PubMed 16735907Mitchell RB, Pereira KD, Friedman NR. Sleep-disordered breathing in children: survey of current practice. Laryngoscope. 2006 Jun;116(6):956-8. doi: 10.1097/01.MLG.0000216413.22408.FD.
- Results publication: PubMed 31053204Masoud AI, Patwari PP, Adavadkar PA, Arantes H, Park C, Carley DW. Validation of the MediByte Portable Monitor for the Diagnosis of Sleep Apnea in Pediatric Patients. J Clin Sleep Med. 2019 May 15;15(5):733-742. doi: 10.5664/jcsm.7764.
- Results publication: PubMed 22701384Lesser DJ, Haddad GG, Bush RA, Pian MS. The utility of a portable recording device for screening of obstructive sleep apnea in obese adolescents. J Clin Sleep Med. 2012 Jun 15;8(3):271-7. doi: 10.5664/jcsm.1912.
- Results publication: PubMed 24083303Massicotte C, Al-Saleh S, Witmans M, Narang I. The utility of a portable sleep monitor to diagnose sleep-disordered breathing in a pediatric population. Can Respir J. 2014 Jan-Feb;21(1):31-5. doi: 10.1155/2014/271061. Epub 2013 Sep 30.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive Sleep, run by Central Hospital, Nancy, 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 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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-Cristina 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?
At-home PG has the same diagnostic value than at-home PSG (time frame: One night). 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 NCT05575921, which also lists 5 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 12 Oct 2022.