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Trial registered on ANZCTR


Registration number
ACTRN12618000124235
Ethics application status
Approved
Date submitted
9/01/2018
Date registered
29/01/2018
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
The AutoMHAN Project: an exploratory study investigating circadian and Autonomic Nervous System characteristics in Mental Health and Neurodevelopmental Disorders in children and adolescents.
Secondary ID [1] 292284 0
Nil
Universal Trial Number (UTN)
U1111-1207-4334
Trial acronym
The AutoMHAN Project:
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 306128 0
Stress, 306129 0
Anxiety, 306197 0
PTSD, 306198 0
ADHD, 306199 0
Autism, 306200 0
Developmental Delay 306201 0
Condition category
Condition code
Mental Health 305242 305242 0 0
Depression
Mental Health 305243 305243 0 0
Anxiety
Mental Health 305244 305244 0 0
Autistic spectrum disorders
Mental Health 305245 305245 0 0
Learning disabilities
Mental Health 305246 305246 0 0
Other mental health disorders
Neurological 305308 305308 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 300002 0
Not applicable
Comparator / control treatment
Subjects with and without the studied conditions will be enrolled to determine differences. Both groups are administered standard psychometric tests. Healthy contol subjects will be recorded for a single 24 hour period.
Control group
Active

Outcomes
Primary outcome [1] 304398 0
Circadian Heart Rate Variability. Measured by 24 hour monitor recording R-R interval and non-averaged Heart Rate data
Timepoint [1] 304398 0
Healthy controls will be recorded at one time point (enrollment). Subjects will be recorded at enrollment and again after 6 weeks of treatment.
Secondary outcome [1] 342053 0
Sleep staging via wearable monitor. Sleep staging analysis performed using heart rate and actigraphy data combined.
Timepoint [1] 342053 0
Healthy controls will be recorded at one time point (enrollment). Subjects will be recorded at enrollment and again after 6 weeks of treatment.

Eligibility
Key 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.
Minimum age
0 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
This is an exploratory study. Interim analyses will be undertaken to more accurately inform power calculations. However based on calculations for regression analyses with three predictor variables, sample sizes of around 100 subjects in each diagnostic group should be sufficient to detect a relationship with a small to medium effect size (f2=0.09) with 89% power at an alpha of 0.05.
Data will be analysed for possible signatures that may characterise the various disorders studied, and to examine if there are specific changes that accompany disease progress and response to treatment. Data will be used to develop diagnostic algorithms based on the ANS and circadian characteristics examined.
All data will be analysed using SPSS software. Multiple groups by time repeated measures ANOVAs will be undertaken to assess change in clinical and physiological variables within groups. Bonferroni correction will be applied to control for Type 1 error. Data will be analysed using multiple regression analyses to examine whether changes in autonomic (HR, HR pattern or HRV) or sleep variables are predictive of improvements in symptoms of MHD and NDD with various pharmacologic treatments.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 9722 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 18497 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 296826 0
Self funded/Unfunded
Name [1] 296826 0
Paul Porter
Address [1] 296826 0
Suite 204, Medical Centre,
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
Joondalup, 6027, WA.
Country [1] 296826 0
Australia
Funding source category [2] 298413 0
Hospital
Name [2] 298413 0
Joondalup Health Campus
Address [2] 298413 0
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country [2] 298413 0
Australia
Primary sponsor type
Individual
Name
A/Professor Paul Porter
Address
Suite 204, Medical Center
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country
Australia
Secondary sponsor category [1] 295816 0
Commercial sector/Industry
Name [1] 295816 0
Medibio Pty Ltd
Address [1] 295816 0
Suite 28, 25 Claremont Street
South Yarra VIC 3141
Country [1] 295816 0
Australia
Other collaborator category [1] 279881 0
University
Name [1] 279881 0
Curtin University
Address [1] 279881 0
Kent Street, Bentley, Perth, Western Australia 6102
Country [1] 279881 0
Australia
Other collaborator category [2] 279882 0
Other Collaborative groups
Name [2] 279882 0
Partnerships for Health Intelligence (The PHI Project)
Address [2] 279882 0
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country [2] 279882 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298061 0
Joondalup Health Campus HREC
Ethics committee address [1] 298061 0
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Ethics committee country [1] 298061 0
Australia
Date submitted for ethics approval [1] 298061 0
28/06/2017
Approval date [1] 298061 0
18/08/2017
Ethics approval number [1] 298061 0
1728

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75862 0
A/Prof Paul Porter
Address 75862 0
Suite 204, Medical Centre
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country 75862 0
Australia
Phone 75862 0
+61 08 9400 9919
Fax 75862 0
+61 08 9400 9909
Email 75862 0
paul.porter@curtin.edu.au
Contact person for public queries
Name 75863 0
A/Prof Paul Porter
Address 75863 0
Suite 204, Medical Centre
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country 75863 0
Australia
Phone 75863 0
+61 08 9400 9919
Fax 75863 0
+61 08 9400 9909
Email 75863 0
paul.porter@curtin.edu.au
Contact person for scientific queries
Name 75864 0
A/Prof Paul Porter
Address 75864 0
Suite 204, Medical Centre
Joondalup Health Campus
Cnr Grand Blvd & Shenton Ave
JOONDALUP WA 6027
Country 75864 0
Australia
Phone 75864 0
+61 08 9400 9919
Fax 75864 0
+61 08 9400 9909
Email 75864 0
paul.porter@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is potentially sensitive
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Summary results
No Results