Clinical trial NCT06966973: Ambulatory Polysomnography in Neurodiverse Children: Feasibility, Quality, and Satisfaction
Official title: Pediatric Polysomnography at Home: Feasibility, Quality, and Satisfaction in Normal Children and Children With Neurodevelopmental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: UPNOS
Sponsor class: OTHER
Collaborators: name: Hôpital Raymond Poincaré
name: AdSalutem Sleep Institute
First posted: 2025-05-13
Enrollment: 563
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All consecutive children who underwent a H-PSH
* Age beetween 2 and 17 years old

Exclusion Criteria:

* No signed informed consent form for study participation

Primary outcomes:
measure: Acceptability of Home Unattended Polysomnography
timeFrame: One day after the polysomnography
Secondary outcomes:
measure: List of symptoms prompting polysomnographic examination
timeFrame: During the polysomnography analysis
measure: Global signal quality across all channels of the polysomnographic recording.
timeFrame: One night of polysomnography.
measure: SpO₂ signal quality of the polysomnographic recording.
timeFrame: One night of polysomnography.
measure: Nasal cannula signal quality of the polysomnography recording.
timeFrame: One night of polysomnography.
measure: RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.
timeFrame: One night of polysomnography.
measure: Sleep latency assessed by Polysomnography.
timeFrame: One night of polysomnography.
measure: Sleep Efficiency assessed by Polysomnography.
timeFrame: One night of polysomnography.
measure: REM latency assessed by Polysomnography.
timeFrame: One night of polysomnography.
measure: Arousal Index assessed by Polysomnography.
timeFrame: One night of polysomnography.
measure: Sleep Stage Distribution assessed by Polysomnography
timeFrame: One night of polysomnography.
measure: Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.
timeFrame: One night of polysomnography.
measure: Respiratory events during sleep assessed by Polysomnography
timeFrame: One night of polysomnography.
Other outcomes:
Locations:
city: Garches
country: France
facility: UPNOS
Study officials:
References: