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Completed

NCT Number: NCT02997566

Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the better will be the prognosis. In this context, heart rate variability (HRV) stands out, which is a non-invasive tool representing autonomic modulation, with potential prognostic value. The literature showed there are no changes in HRV at rest using linear methods of analysis, but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and provide additional information to the linear. Objective: to analyze autonomic modulation using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in comparison to typical children. In addition, to correlate HRV analysis between them, also between behavior and severity of the disease. Methods: this study involves both typical children and children with ASD. Autonomic modulation will be performed using nonlinear indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to identify differences between moments and protocols two-way analysis of variance will be used along with the Bonferroni post-test or Dunn post-test according to the data distribution. Statistical significance will be set at 5%.

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Key information

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060900, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children with autistic disorder or typical development.

Exclusion criteria

  • Participants that do not participant of all evaluations.
  • Participants with an error superior to 5% in the RR intervals series.

Treatment and study plan

Autonomic evaluation

Other

Primary outcomes

  1. Autonomic evaluation

    Time frame: June, 2017

    Heart rate variability at rest, during facial expression games and finish at rest.

Secondary outcomes

  1. Childhood Autism Rating Scale (CARS)

    Time frame: June, 2017

  2. Autistic Behavior Checklist

    Time frame: June, 2017

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Jun 4, 2020

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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