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

NCT ID: NCT06966973

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neurodevelopmental Disorders Pediatric Sleep Apnea Periodic Leg Movements, Excessive, Sleep-Related Polysomnography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All children aged 2 to 17

Polysomnograpy

Intervention Type OTHER

All successive patients who underwent polysomnography

Interventions

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Polysomnograpy

All successive patients who underwent polysomnography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital Raymond Poincaré

OTHER

Sponsor Role collaborator

AdSalutem Sleep Institute

OTHER

Sponsor Role collaborator

UPNOS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UPNOS

Garches, , France

Site Status

Countries

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France

Related Links

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Other Identifiers

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2018-AMBUPED-001

Identifier Type: -

Identifier Source: org_study_id

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