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

NCT06966973 | Completed

• 1 other identifier: 2018-AMBUPED-001
• Study Type: observational
• Target: 563
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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).

  One day after the polysomnography

Secondary Outcomes (12)

• List of symptoms prompting polysomnographic examination

  During the polysomnography analysis

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

  One night of polysomnography.

• SpO₂ signal quality of the polysomnographic recording.

  One night of polysomnography.

• Nasal cannula signal quality of the polysomnography recording.

  One night of polysomnography.

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

  One night of polysomnography.

Study Arms (1)

All children aged 2 to 17

Other: Polysomnograpy

Interventions

Polysomnograpy OTHER

All successive patients who underwent polysomnography

All children aged 2 to 17

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• No signed informed consent form for study participation

Sponsors & Collaborators

• UPNOS: lead
• Hôpital Raymond Poincaré: collaborator
• AdSalutem Sleep Institute: collaborator

Study Sites (1)

UPNOS

Garches, 92380, France

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neurodevelopmental Disorders; Nocturnal Myoclonus Syndrome; Attention Deficit Disorder with Hyperactivity; Learning Disabilities

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Parasomnias; Attention Deficit and Disruptive Behavior Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: May 13, 2025
• Study Start: January 1, 2018
• Primary Completion: February 28, 2023
• Study Completion: September 30, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

FR (1)