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The AutoMHAN Project: an exploratory study investigating circadian and Autonomic Nervous System characteristics such as heart rate, sleep and activity in Mental Health and Neurodevelopmental Disorders in children and adolescents.

The AutoMHAN Project: an exploratory study investigating circadian and Autonomic Nervous System characteristics in Mental Health and Neurodevelopmental Disorders in children and adolescents.

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000124235
Acronym
The AutoMHAN Project:
Enrollment
4
Registered
2018-01-29
Start date
2018-02-01
Completion date
2018-04-03
Last updated
2022-08-09

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

Conditions

None listed

Brief summary

Mental illness accounts for significant childhood morbidity and mortality and is an area of national and global importance. Mental health problems are the dominant cause of childhood disability and contribute to 45% of the global disease burden in young people (10-24 years). • The recent Five-Year Youth Mental Health Report reveals alarming figures of one in four young people meeting diagnostic criteria for probable serious mental illness. This has increased from 18.7% (2012) to 22.8% (2016). • Half of all lifetime mental illnesses emerge by age 14, and 75% by age 24. • The negative long-term consequences of childhood mental illness include lower educational attainment, unemployment, substance use and addiction, crime and incarceration, self-harm and suicide. • Suicide is the leading cause of deaths in young people aged 15-24. Key policy recommendations from the report include support for the development of technology that provides an alternative to face-to-face health provider consultations. The prevention, identification and treatment of mental illness is a priority area for national and global health programs. Diagnostic and Management Need: Clinicians have not been able to achieve more than modest agreement in diagnosing mental illness, and the lack of objective measures for evaluating treatment has left long treatment titration cycles and suboptimal management. Indeed, the treatment of adolescent depression remains complicated and controversial because there are no objective measures of treatment effectiveness. New Research and The AutoMHaN Project: Research undertaken in Western Australia (WA) showed that there is a relationship between psychiatric status and 24-hour or ‘circadian’ heart rate (CHR). Broadly, different mental illnesses, such as Generalised Anxiety Disorder and Depression, are associated with distinctly different changes in CHR and this relationship is state-dependent: a change in clinical status is associated with a change in CHR. The autonomic nervous system (ANS) plays a key role in regulating basic body rhythms and activities including heart rate. Under these circumstances, evidence of distinct differences in CHR in different forms of mental illness, especially during sleep when environmental influences on heart rate are minimal, are an objective indication of basic differences between disorders. This suggests that an analysis of CHR can add an objective dimension to diagnostic assessment and the evaluation of treatment. The aim of this study is to see whether similar results can be obtained in children and adolescents. This pilot study will compare CHR from healthy children with CHR from children with different mental health and neurodevelopmental disorders including depression, anxiety, ADHD and autism. The aim is to see whether an analysis of CHR can provide objective indications of these conditions, differentiate between them and provide objective indications of their response to treatment.

Interventions

Observation of Circadian Autonomic changes in children and adolescents with and without the conditions of Stress, Depression, Anxiety, PTSD, ADHD, Autism and Developmental delay by use of a 24-hour wearable monitor to record heart rate variability (beat to beat), sleep, actigraphy and breathing rate. The monitor will be worn at diagnosis for 24 hours and again fro a 24 hour recording at completion of 6 weeks treatment. All clinical diagnoses will be confirmed by the subjects attending physician

Observation of Circadian Autonomic changes in children and adolescents with and without the conditions of Stress, Depression, Anxiety, PTSD, ADHD, Autism and Developmental delay by use of a 24-hour wearable monitor to record heart rate variability (beat to beat), sleep, actigraphy and breathing rate. The monitor will be worn at diagnosis for 24 hours and again fro a 24 hour recording at completion of 6 weeks treatment. All clinical diagnoses will be confirmed by the subjects attending physician and standardised neuropsychometric instruments administered. Follow up recordings will be collected post-treatment of underlying condition to determine the effect of therapy on underlying Autonomic Regulation. Subject recruitment from Specialist Paediatric and Psychiatry services with ongoing management provided by that specialist.

Sponsors

A/Professor Paul Porter
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
Yes

Inclusion criteria

Subjects with and without the studied conditions under 18 years of age. Healthy subjects (those without the studied diseases and without exclusion criteria) identified from their primary care physicians rooms or clinics and who have normal psychometric testing. Subjects with studied conditions enrolled after identification and confirmation by their primary care physician and confirmed with psychometic testing. Studied conditions include Depression, Stress, Anxiety, PTSD, ADHD, Autism and neurodevelopmental delay.

Exclusion criteria

1. ADHD under age five years 2. Known cardiac abnormality 3. Uncontrolled seizure disorders 4. Known allergy to medical adhesives 5. Under care of Department of Child Protection 6. Use of beta-blocker medication 7. Psychosis 8. Bipolar Affective Disorder 9. History of central or obstructive sleep apnoea

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026