Trial Review

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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
22/07/2022
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
Sex
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
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study was unable to commence at site due to contractual reasons. No participants were recruited to the study beyond pilot data.
Date of first participant enrolment
Anticipated
1/02/2018
Actual
1/02/2018
Date of last participant enrolment
Anticipated
Actual
3/04/2018
Date of last data collection
Anticipated
15/02/2021
Actual
Sample size
Target
500
Accrual to date
Final
4
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
Country [1] 296826 0
Australia
Funding source category [2] 298413 0
Hospital
Name [2] 298413 0
Joondalup Health Campus
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
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
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
[email protected]
Contact person for public queries
Name 75863 0
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
[email protected]
Contact person for scientific queries
Name 75864 0
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
[email protected]

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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.