Sleep Apnea, ObstructiveNCT06754800
Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy
An observational study of Sleep Apnea, Obstructive, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Polysomnography in routine care
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2024to 6 Jan 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSA by th ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrtinologist, genetician
Who may be able to join
- Children with suspicion of OSA
- Interpretable polysomnography
Who cannot join
- Non-interpretable polysomnography
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital of Nancy
Nancy, 54000
Iulia Ioan, +33383154794, ic.ioan@chru-nancy.fr
Iulia Ioan, MD PhD
About this study
Official title: Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy Including Hypopneas Associated With Autonomic Micro-arousals
Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. To compensate for this disadvantage, hypopneas linked with autonomic micro-arousals can be calculated from the drop in pulse wave amplitude (obtained dy oximetry), as increased respiratory efforts are related to autonomic nervous system activation, tachycardia, and elevated blood pressure.
The aim of this study is to compare OAHI obtained by RP alone or by RP considering hypopneas associated with autonomic micro-arousals with OAHI by polysomnography (PSG).
Read the detailed description
The diagnosis of obstructive sleep apnea syndrome in children (OSA) requires to perform a polysomnography (PSG) in hospitalization with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is difficult to perform in children, with several sensors and electrodes to install.
Respiratory polygraphy (RP) which uses only respiratory signals (without the neurophysiological signals ) can be used for the diagnosis of OSA but it underestimates OAHI because the hypopneas associated with cortical micro-arousals are not taken into account. An alternative to overcome this disadvantage is to determine the presence of autonomic micro-arousals because the increase in respiratory efforts during sleep is associated with activation of the autonomic nervous system and cardiovascular effects, such as tachycardia and an increase in blood pressure. Consequently, these respiratory efforts are associated either with autonomic activation or with cortical micro-arousal. One method to determine autonomic micro-arousals is photo-plethysmography which reflects sympathetic activation. Photoplethysmography is obtained by oximetry signal and is a non-invasive technique based on measuring the relative absorption by the blood of red light and infrared light through the finger. The pulsation of arterial blood flow through the finger arteries modulates light absorption and generates a pulse wave signal.
Autonomic micro-arousals will be calculated according to 3 algorithms: reduction of 1) 30%; 2) 40%; 3) 50% of the photoplethysmography signal compared to the baseline and the hypopneas associated with these decreases will be taken into account in the calculation of the OAHI. Consequently, 3 OAHI will be obtained by RP including hypopneas associated with autonomic micro-arousals.
The aim of this study is to compare OAHI obtained by RP considering hypopneas associated with autonomic micro-arousals with OAHI by PSG.
The hypothesis of this study is that RP by adding hypopneas associated with autonomic micro-arousals can identify OSA in children.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Polysomnography in routine care
- Keywords
- child, polysomnography, polygraphy, autonomic nervous system
- 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.
Polysomnography in routine careDiagnostic test
Children performed a polysomnography in routine clinical care
What is being measured
The primary outcome is the main question the study is designed to answer.
OAHI in RP including hypopneas associated with autonomic micro-arousals correlated with OAHI by PSG
Value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) correlated with OAHI by PSG
Measured: A single night
Secondary outcomes (3)
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose OSA reported to PSG
Sensitivity and specificity of the OAHI obtained by RP including hypopneas associated with autonomic micro-arousals to identify OSA in children
Measured: A single night
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose moderate-severe OSA reported to PSG
Sensitivity and specificity of the OAHI obtained by RP including hypopneas associated with autonomic micro-arousals to identify moderate-severe OSA in children
Measured: A single night
Determine the best of the 3 algorithms that better correlates with OAHI by PSG
Comparison between the 3 correlation coefficients obtained from the correlation between value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) and OAHI by PSG
Measured: A single night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start22 Dec 2024 (estimated)
- Primary completion28 Dec 2024 (estimated)
- Study completion6 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep 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
- Retrospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754800
- Sponsor's protocol ID
- 2024PI033
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grote L, Zou D, Kraiczi H, Hedner J. Finger plethysmography--a method for monitoring finger blood flow during sleep disordered breathing. Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):141-52. doi: 10.1016/s1569-9048(03)00090-9.
PubMed 12853006Haba-Rubio J, Darbellay G, Herrmann FR, Frey JG, Fernandes A, Vesin JM, Thiran JP, Tschopp JM. Obstructive sleep apnea syndrome: effect of respiratory events and arousal on pulse wave amplitude measured by photoplethysmography in NREM sleep. Sleep Breath. 2005 Jun;9(2):73-81. doi: 10.1007/s11325-005-0017-y.
PubMed 15875228Ioan I, Schweitzer C, Touil Y, Da Mota S, Coutier L, Guyon A, Franco P. Respiratory polygraphy combined with pulse wave amplitude drops for the diagnosis of obstructive sleep apnea in pediatric patients. Sleep Med. 2025 Sep;133:106618. doi: 10.1016/j.sleep.2025.106618. Epub 2025 May 30.
PubMed 40483836
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Obstructive Sleep Apnea Diagnosis by Respiratory Polygraphy Including Hypopneas Associated With Autonomic Micro-arousals
- ClinicalTrials.gov ID
- NCT06754800
- Acronym / sponsor ID
- 2024PI033
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- child, polysomnography, polygraphy, autonomic nervous system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 22 Dec 2024 (estimated)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 6 Jan 2025 (estimated)
- First posted
- 1 Jan 2025 (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.
Respiratory polygraphy (RP) can be used to detect obstructive sleep apnea syndrome in children (OSA) , but it underestimates the obstructive apnea-hypopnea index (OAHI) because hypopneas associated with cortical arousals are not evaluated. To compensate for this disadvantage, hypopneas linked with autonomic micro-arousals can be calculated from the drop in pulse wave amplitude (obtained dy oximetry), as increased respiratory efforts are related to autonomic nervous system activation, tachycardia, and elevated blood pressure.
The aim of this study is to compare OAHI obtained by RP alone or by RP considering hypopneas associated with autonomic micro-arousals with OAHI by polysomnography (PSG).
Detailed description
The diagnosis of obstructive sleep apnea syndrome in children (OSA) requires to perform a polysomnography (PSG) in hospitalization with video surveillance and monitoring by a nurse to put the sensors back on the child if necessary. PSG gives the obstructive apnea-hypopnea index (OAHI) necessary for the diagnosis of OSA and to determine its severity. But PSG is difficult to perform in children, with several sensors and electrodes to install.
Respiratory polygraphy (RP) which uses only respiratory signals (without the neurophysiological signals ) can be used for the diagnosis of OSA but it underestimates OAHI because the hypopneas associated with cortical micro-arousals are not taken into account. An alternative to overcome this disadvantage is to determine the presence of autonomic micro-arousals because the increase in respiratory efforts during sleep is associated with activation of the autonomic nervous system and cardiovascular effects, such as tachycardia and an increase in blood pressure. Consequently, these respiratory efforts are associated either with autonomic activation or with cortical micro-arousal. One method to determine autonomic micro-arousals is photo-plethysmography which reflects sympathetic activation. Photoplethysmography is obtained by oximetry signal and is a non-invasive technique based on measuring the relative absorption by the blood of red light and infrared light through the finger. The pulsation of arterial blood flow through the finger arteries modulates light absorption and generates a pulse wave signal.
Autonomic micro-arousals will be calculated according to 3 algorithms: reduction of 1) 30%; 2) 40%; 3) 50% of the photoplethysmography signal compared to the baseline and the hypopneas associated with these decreases will be taken into account in the calculation of the OAHI. Consequently, 3 OAHI will be obtained by RP including hypopneas associated with autonomic micro-arousals.
The aim of this study is to compare OAHI obtained by RP considering hypopneas associated with autonomic micro-arousals with OAHI by PSG.
The hypothesis of this study is that RP by adding hypopneas associated with autonomic micro-arousals can identify OSA in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 2 to 19 years adressed for a PSG in routine clinical care for suspicion of OSA by th ear-nose-throat physician, pediatric pulmonologist, sleep specialist, endocrtinologist, genetician
Key inclusion criteria (2 listed)
- Children with suspicion of OSA
- Interpretable polysomnography
Key exclusion criteria (1 listed)
- Non-interpretable polysomnography
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 |
|---|---|---|
| Polysomnography in routine careChildren performed a polysomnography in routine clinical care | Diagnostic test | – |
Primary outcome
OAHI in RP including hypopneas associated with autonomic micro-arousals correlated with OAHI by PSG
Time frame: A single night
Value of OAHI in RP including hypopneas associated with autonomic micro-arousals obtained by 3 algorithms (3 values of OAHI) correlated with OAHI by PSG
3 secondary outcomes
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose OSA reported to PSG
Time frame: A single night
Diagnostic ability of RP including hypopneas associated with autonomic micro-arousals (obtained by the 3 algorithms) to diagnose moderate-severe OSA reported to PSG
Time frame: A single night
Determine the best of the 3 algorithms that better correlates with OAHI by PSG
Time frame: A single night
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Results publication: PubMed 12853006Grote L, Zou D, Kraiczi H, Hedner J. Finger plethysmography--a method for monitoring finger blood flow during sleep disordered breathing. Respir Physiol Neurobiol. 2003 Jul 16;136(2-3):141-52. doi: 10.1016/s1569-9048(03)00090-9.
- Results publication: PubMed 15875228Haba-Rubio J, Darbellay G, Herrmann FR, Frey JG, Fernandes A, Vesin JM, Thiran JP, Tschopp JM. Obstructive sleep apnea syndrome: effect of respiratory events and arousal on pulse wave amplitude measured by photoplethysmography in NREM sleep. Sleep Breath. 2005 Jun;9(2):73-81. doi: 10.1007/s11325-005-0017-y.
- Derived from this study: PubMed 40483836Ioan I, Schweitzer C, Touil Y, Da Mota S, Coutier L, Guyon A, Franco P. Respiratory polygraphy combined with pulse wave amplitude drops for the diagnosis of obstructive sleep apnea in pediatric patients. Sleep Med. 2025 Sep;133:106618. doi: 10.1016/j.sleep.2025.106618. Epub 2025 May 30.
- Individual participant dataSharing planned: No
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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.
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 Sleep Apnea, Obstructive, 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 2 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: opening soon, as of the sponsor's last update on 1 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OAHI in RP including hypopneas associated with autonomic micro-arousals correlated with OAHI by PSG (time frame: A single 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 NCT06754800, which also lists 3 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 1 Jan 2025.