Neurodevelopmental DisordersNCT06966973
Ambulatory Polysomnography in Neurodiverse Children: Feasibility, Quality, and Satisfaction
An observational study of Neurodevelopmental Disorders and Pediatric Sleep Apnea, run by UPNOS at 1 site in France.
Trial summary
Laboratory polysomnography is the gold standard for objective sleep measurement. With hospital waiting times becoming increasingly long, outpatient polysomnography seems a good solution. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Pediatric Sleep Apnea, Periodic Leg Movements, Excessive, Sleep-Related
- What is being tested?
- Polysomnograpy
- How many people
- 563 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 30 Sep 2024
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consisted of any children coming to the doctor's office for a home unattended polysomnography, aged between 2 and 17 years at the time of polysomnography, and whose parents had signed a consent form for polysomnography and data collection.
Who may be able to join
- All consecutive children who underwent a H-PSH
- Age beetween 2 and 17 years old
Who cannot join
- No signed informed consent form for study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Polysomnography at Home: Feasibility, Quality, and Satisfaction in Normal Children and Children With Neurodevelopmental Disorders
Laboratory polysomnography is the gold standard for objective sleep measurement. With hospital waiting times becoming increasingly long, outpatient polysomnography seems a good solution. Children are at greater risk of developing sleep disorders and polysomnography in the hospital laboratory can be a stressful examination for these children and their parents. This can be even more the case in populations of children with neurodevelopmental disorders, such as Attention Deficit Disorder with or without Hyperactivity (ADHD), or dys- learning disorders. Several studies have already demonstrated the feasibility of ambulatory, in a home setting, polysomnography in children. The objective of this study is to demonstrate the acceptability and satisfaction of performing polysomnography at home on a large cohort of children, including children with neurodevelopmental disorders.
- Conditions
- Neurodevelopmental Disorders, Pediatric Sleep Apnea, Periodic Leg Movements, Excessive, Sleep-Related, Polysomnography
- Being tested
- Polysomnograpy
- Keywords
- Home unattended polysomnography, Attention deficit disorder, Attention deficit hyperactivity disorder, Learning disorders
- Medical subject headings
- Neurodevelopmental Disorders, Nocturnal Myoclonus Syndrome, Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnograpyOther
All successive patients who underwent polysomnography
| Study group | Role | What they receive |
|---|---|---|
| All children aged 2 to 17 | Not described Receives: Other: Polysomnograpy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Home Unattended Polysomnography
Parents and children completed 10 cm visual analog scales (VAS) to assess their satisfaction with the home recording (scored from 0 (not enjoyed) to 10 (very satisfied) and preference for home versus laboratory PSG (scored from 0 preference for H-PSG to 10 preference for L-PSG).
Measured: One day after the polysomnography
Secondary outcomes (12)
List of symptoms prompting polysomnographic examination
The following symptoms are collected through a standardized questionnaires completed by participants. Only the presence or absence of each symptom is recorded: Disturbed attention; Fatigue;Snoring; Nocturnal sweating; Kick; Enuresis; Nocturnal awakening; Sleepiness PPDS > 16; Morning headache; Difficulty staying asleep.
Measured: During the polysomnography analysis
Global signal quality across all channels of the polysomnographic recording.
Global assessment of signal integrity across all polysomnography channels, expressed as a percentage over the course of a full-night recording.
Measured: One night of polysomnography.
SpO₂ signal quality of the polysomnographic recording.
SpO₂ signal quality expressed as a percentage over the course of a full-night recording.
Measured: One night of polysomnography.
Nasal cannula signal quality of the polysomnography recording.
Nasal cannula signal quality expressed as a percentage over the course of a full-night recording.
Measured: One night of polysomnography.
RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.
RIP (Respiratory Inductance Plethysmography) quality expressed as a percentage over the course of a full-night recording.
Measured: One night of polysomnography.
Sleep latency assessed by Polysomnography.
Time from lights-off to the onset of sleep in minutes
Measured: One night of polysomnography.
Sleep Efficiency assessed by Polysomnography.
Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography, expressed as a percentage.
Measured: One night of polysomnography.
REM latency assessed by Polysomnography.
Time from sleep onset to the first epoch of Rapid Eyes Movement (REM) sleep in minutes.
Measured: One night of polysomnography.
Arousal Index assessed by Polysomnography.
Number of electroencephalography arousals per hour of sleep assessed by Polysomnography.
Measured: One night of polysomnography.
Sleep Stage Distribution assessed by Polysomnography
Sleep stage distribution during nocturnal sleep, defined as the percentage of total sleep time spent in N1, N2, N3, and REM stages, assessed by polysomnography
Measured: One night of polysomnography.
Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.
Number of periodic limb movements per hour of sleep (PLMS Index), assessed by Polysomnographic recording of bilateral anterior tibialis electromyography.
Measured: One night of polysomnography.
Respiratory events during sleep assessed by Polysomnography
Respiratory events during nocturnal sleep. This includes saturation, nasal air flow and movement of the stomach and chest, together showing the number of apneas and hypopneas per hour of sleep assessed by full-night polysomnographic recording.
Measured: One night of polysomnography.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2018
- Primary completion28 Feb 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPNOS
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, AdSalutem Sleep Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966973
- Sponsor's protocol ID
- 2018-AMBUPED-001
- Status last verified
- May 2025
- First submitted
- 13 Mar 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Observational study on routine practice. The individual data collected are specific to the protocol and cannot be directly reused without the full set of tools and methodologies developed for this study. Their dissemination could be misinterpreted or non-reproducible outside this context.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Polysomnography at Home: Feasibility, Quality, and Satisfaction in Normal Children and Children With Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT06966973
- Acronym / sponsor ID
- 2018-AMBUPED-001
- Conditions
- Neurodevelopmental Disorders, Pediatric Sleep Apnea, Periodic Leg Movements, Excessive, Sleep-Related, Polysomnography
- Keywords
- Home unattended polysomnography, Attention deficit disorder, Attention deficit hyperactivity disorder, Learning disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- UPNOSUniversity, hospital or other
- Collaborators
- Hôpital Raymond Poincaré, AdSalutem Sleep Institute
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 May 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.
Laboratory polysomnography is the gold standard for objective sleep measurement. With hospital waiting times becoming increasingly long, outpatient polysomnography seems a good solution. Children are at greater risk of developing sleep disorders and polysomnography in the hospital laboratory can be a stressful examination for these children and their parents. This can be even more the case in populations of children with neurodevelopmental disorders, such as Attention Deficit Disorder with or without Hyperactivity (ADHD), or dys- learning disorders. Several studies have already demonstrated the feasibility of ambulatory, in a home setting, polysomnography in children. The objective of this study is to demonstrate the acceptability and satisfaction of performing polysomnography at home on a large cohort of children, including children with neurodevelopmental disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All children aged 2 to 17 | – | Other: Polysomnograpy |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consisted of any children coming to the doctor's office for a home unattended polysomnography, aged between 2 and 17 years at the time of polysomnography, and whose parents had signed a consent form for polysomnography and data collection.
Key inclusion criteria (2 listed)
- All consecutive children who underwent a H-PSH
- Age beetween 2 and 17 years old
Key exclusion criteria (1 listed)
- No signed informed consent form for study participation
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 |
|---|---|---|
| PolysomnograpyAll successive patients who underwent polysomnography | Other | All children aged 2 to 17 |
Primary outcome
Acceptability of Home Unattended Polysomnography
Time frame: One day after the polysomnography
Parents and children completed 10 cm visual analog scales (VAS) to assess their satisfaction with the home recording (scored from 0 (not enjoyed) to 10 (very satisfied) and preference for home versus laboratory PSG (scored from 0 preference for H-PSG to 10 preference for L-PSG).
12 secondary outcomes
List of symptoms prompting polysomnographic examination
Time frame: During the polysomnography analysis
Global signal quality across all channels of the polysomnographic recording.
Time frame: One night of polysomnography.
SpO₂ signal quality of the polysomnographic recording.
Time frame: One night of polysomnography.
Nasal cannula signal quality of the polysomnography recording.
Time frame: One night of polysomnography.
RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.
Time frame: One night of polysomnography.
Sleep latency assessed by Polysomnography.
Time frame: One night of polysomnography.
Sleep Efficiency assessed by Polysomnography.
Time frame: One night of polysomnography.
REM latency assessed by Polysomnography.
Time frame: One night of polysomnography.
Arousal Index assessed by Polysomnography.
Time frame: One night of polysomnography.
Sleep Stage Distribution assessed by Polysomnography
Time frame: One night of polysomnography.
Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.
Time frame: One night of polysomnography.
Respiratory events during sleep assessed by Polysomnography
Time frame: One night of polysomnography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Observational study on routine practice. The individual data collected are specific to the protocol and cannot be directly reused without the full set of tools and methodologies developed for this study. Their dissemination could be misinterpreted or non-reproducible outside this context.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neurodevelopmental Disorders and Pediatric Sleep Apnea, run by UPNOS 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: finished, as of the sponsor's last update on 13 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Home Unattended Polysomnography (time frame: One day after the polysomnography). 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 13 May 2025.