Ambulatory Polysomnography in Neurodiverse Children: Feasibility, Quality, and Satisfaction

Pediatric Polysomnography at Home: Feasibility, Quality, and Satisfaction in Normal Children and Children With Neurodevelopmental Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06966973

Enrollment

563

Registered

2025-05-13

Start date

2018-01-01

Completion date

2024-09-30

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERPolysomnograpy

All successive patients who underwent polysomnography

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Acceptability of Home Unattended Polysomnography	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).

Secondary

Measure	Time frame	Description
Global signal quality across all channels of the polysomnographic recording.	One night of polysomnography.	Global assessment of signal integrity across all polysomnography channels, expressed as a percentage over the course of a full-night recording.
SpO₂ signal quality of the polysomnographic recording.	One night of polysomnography.	SpO₂ signal quality expressed as a percentage over the course of a full-night recording.
Nasal cannula signal quality of the polysomnography recording.	One night of polysomnography.	Nasal cannula signal quality expressed as a percentage over the course of a full-night recording.
RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.	One night of polysomnography.	RIP (Respiratory Inductance Plethysmography) quality expressed as a percentage over the course of a full-night recording.
Sleep latency assessed by Polysomnography.	One night of polysomnography.	Time from lights-off to the onset of sleep in minutes
List of symptoms prompting polysomnographic examination	During the polysomnography analysis	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.
REM latency assessed by Polysomnography.	One night of polysomnography.	Time from sleep onset to the first epoch of Rapid Eyes Movement (REM) sleep in minutes.
Arousal Index assessed by Polysomnography.	One night of polysomnography.	Number of electroencephalography arousals per hour of sleep assessed by Polysomnography.
Sleep Stage Distribution assessed by Polysomnography	One night of 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
Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.	One night of polysomnography.	Number of periodic limb movements per hour of sleep (PLMS Index), assessed by Polysomnographic recording of bilateral anterior tibialis electromyography.
Respiratory events during sleep assessed by Polysomnography	One night of 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.
Sleep Efficiency assessed by Polysomnography.	One night of polysomnography.	Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography, expressed as a percentage.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026