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Completed

NCT Number: NCT06966973

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Communication Disorders Dyssomnias Learning Disabilities Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nocturnal Myoclonus Syndrome Parasomnias Pathological Conditions, Signs and Symptoms Pediatric Sleep Apnea Periodic Leg Movements, Excessive, Sleep-Related Polysomnography Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UPNOS

Garches, 92380, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnograpy

Other

All successive patients who underwent polysomnography

Primary outcomes

  1. 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).

Secondary outcomes

  1. List of symptoms prompting polysomnographic examination

    Time frame: 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.

  2. Global signal quality across all channels of the polysomnographic recording.

    Time frame: 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.

  3. SpO₂ signal quality of the polysomnographic recording.

    Time frame: One night of polysomnography.

    SpO₂ signal quality expressed as a percentage over the course of a full-night recording.

  4. Nasal cannula signal quality of the polysomnography recording.

    Time frame: One night of polysomnography.

    Nasal cannula signal quality expressed as a percentage over the course of a full-night recording.

  5. RIP (Respiratory Inductance Plethysmography) quality of the polysomnography recording.

    Time frame: One night of polysomnography.

    RIP (Respiratory Inductance Plethysmography) quality expressed as a percentage over the course of a full-night recording.

  6. Sleep latency assessed by Polysomnography.

    Time frame: One night of polysomnography.

    Time from lights-off to the onset of sleep in minutes

  7. Sleep Efficiency assessed by Polysomnography.

    Time frame: One night of polysomnography.

    Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography, expressed as a percentage.

  8. REM latency assessed by Polysomnography.

    Time frame: One night of polysomnography.

    Time from sleep onset to the first epoch of Rapid Eyes Movement (REM) sleep in minutes.

  9. Arousal Index assessed by Polysomnography.

    Time frame: One night of polysomnography.

    Number of electroencephalography arousals per hour of sleep assessed by Polysomnography.

  10. Sleep Stage Distribution assessed by Polysomnography

    Time frame: 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

  11. Number of Periodic Limb Movements per Hour of Sleep (PLMS Index), measured by Polysomnography.

    Time frame: One night of polysomnography.

    Number of periodic limb movements per hour of sleep (PLMS Index), assessed by Polysomnographic recording of bilateral anterior tibialis electromyography.

  12. Respiratory events during sleep assessed by Polysomnography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

UPNOS

Other

Collaborators

  • AdSalutem Sleep Institute
  • Hôpital Raymond Poincaré

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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