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Trial registered on ANZCTR


Registration number
ACTRN12616000128493p
Ethics application status
Submitted, not yet approved
Date submitted
2/02/2016
Date registered
4/02/2016
Date last updated
4/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation Of A Circadian Heart Rate Monitoring Device For Use To Measures Stress Levels In A Convenience Sample of Healthy Adults
Scientific title
Validation Of A Circadian Heart Rate Monitoring Device For Use To Measures Stress Levels In A Convenience Sample of Healthy Adults
Secondary ID [1] 288463 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 297495 0
Condition category
Condition code
Mental Health 297683 297683 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Aim to assess whether a currently available heart rate monitoring device worn over a 24 hour period thus measuring circadian heart rate (CHR) patterns, can provide objective indications of stress. The heart rate monitoring device is a small device worn with a strap covering the skin over the chest region. CHR will be monitored on 4 separate occasions: twice in the first week and twice again after an interval 2-3 weeks. At each assessment point the device is worn for 24 hours. Measures of CHR will be compared with data obtained from self-report mood and stress tools to evaluate consistency of results, and cross-sectional and predictive validity. Participants will be asked to download an App that contains the self-report questionnaires and provides feedback on the heart rate recordings.
Intervention code [1] 293798 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297222 0
Measurement of stress levels using CHR patterns derived from a participant ECG data file recorded on the 'Zephyr HxM Smart Heart Rate Monitor'. This device records the participant’s posture, accelerometer data, and ECG signal. The participant wears this device for up to 24 hours at each assessment point.
Timepoint [1] 297222 0
Baseline measurement involves 2 participant recordings with ECG data file obtained from the Zephyr Monitor. Another two recordings 3 weeks after first assessment.
Secondary outcome [1] 320381 0
Self-report levels of stress through DASS-21 and the Perceived Stress Scale (PSS; Cohen, 1988)
Timepoint [1] 320381 0
At baseline and at 3 week follow-up
Secondary outcome [2] 320382 0
Participant’s current emotional wellbeing assessed using the Warwick-Edinburgh Mental Well-being Scale (Tennant et al., 2007)
Timepoint [2] 320382 0
At baseline and 3 week follow-up
Secondary outcome [3] 320383 0
User acceptability of App assessed by 5-point Likert scale
Timepoint [3] 320383 0
At baseline and 3 week follow-up
Secondary outcome [4] 320385 0
Screening for major depressive disorder, panic disorder, psychotic disorders, generalised anxiety disorder and posttraumatic stress disorder with the M.I.N.I. International Neuropsychiatric Interview (M.I.N.I.). Participants who score in the severe range for stress, depression or anxiety on the DASS-21, as well as randomly selected participants (for a total n=50) will be asked to attend another face-to-face meeting for this screening interview.
Timepoint [4] 320385 0
At 3 week follow-up.
Secondary outcome [5] 320439 0
Physical activity assessed using the Brief Physical activity assessment scale (Marshall et al., 2005)
Timepoint [5] 320439 0
At baseline and 3 week follow-up
Secondary outcome [6] 320440 0
Sleeping patterns assessed using the Bergen Insomnia Scale Pallesen et al., 2008)
Timepoint [6] 320440 0
At baseline and 3 week follow-up
Secondary outcome [7] 320441 0
Emotional resilience assessed using the Brief Resilience Scale (Smith et al., 2008)
Timepoint [7] 320441 0
At baseline and 3 week follow-up
Secondary outcome [8] 320442 0
Mood symptoms assessed using DASS-21 (Lovibond & Lovibond, 1995)
Timepoint [8] 320442 0
At baseline and 3 week follow-up
Secondary outcome [9] 320443 0
Anxiety assessed using the DASS-21 (Lovibond & Lovibond, 1995)
Timepoint [9] 320443 0
At baseline and 3 week follow-up
Secondary outcome [10] 320444 0
Comfort of wearing Zephyr Monitor using a 5-point Likert scale
Timepoint [10] 320444 0
At baseline and 3 week follow-up

Eligibility
Key inclusion criteria
Physically healthy individuals aged 18 years and older
Access to a smartphone:
1) Android version 4.4 or later
2) iOS 8 or later
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Individuals who have difficulty reading and understanding English
2) Regular/severe alcohol and/or other substance abuse.
3) Prescribed medication with a recognized cardiac effect (e.g. beta-blockers, thyroxine, clozapine)
4) History and/or evidence of coronary heart disease
5) Physical illness with a recognized effect on heart rate

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis
In Calculating the degrees of freedom (df) we have:
the observation - algorithm result which has 3 levels (normal-mild, moderate, and severe)
the expected – expert rating which has 3 levels (normal-mild, moderate, and severe)
For Chi-squared, df = (3-1) x (3-1) = 4

In Calculating the effect size we need to observe the hypothesised difference between subjects with moderate stress compared to those with severe stress (10% versus 25%) as opposed to (33% versus 33%) which would require an effect size of 0.46.

Given this medium effect size, in conjunction with an alpha of 0.05 and power of 0.95, with 4 degrees of freedom would require a sample size of 88.

As these 88 participants represent only 35% of the general population, in order to achieve appropriate power for delineating between stress groups, requires a sample size of 88 x 1/0.35 = 251.4. Therefore this study requires a sample of 252 participants, which we expect to lose 10% to natural attrition, and 10% due to unusable data due to ECG recording artifact, we request permission to recruit up to 300 participants.


The circadian heart rate output metrics will be compared with self-report data as follows:

1. Cross-sectionally against the measures of stress depression and anxiety (quantitative discrete variables), using agreement statistics for dichotomous variables and ROC curves for continuous variables. The analysis would include a comparison of two quantitative variables – with the algorithm providing a measure of the degree of variation from normal (ie. A continuous variable with a true zero) and compare this to the outcome from the self-reports (DASS-21 etc)- (quantitative discrete variable). This would permit analyses using correlation or regression models.

2. For categorical algorithm outputs (Normal-mild, Moderate, Serious) and self-report measures are quantitative then we could employ ROC curves to identify appropriate cutoffs with the self-report tools. This will allow us to maximize the predictive ability of the algorithm by identifying which cutoffs give the best results in regards to the sensitivity and specificity for the each of the levels.

3. For categorical algorithm outputs and MINI categories (interview) we will complete Chi Sqd – goodness of fit, or a multinomial logistic regression.

4. Longitudinally by validating changes in the participant’s CHR status with changes in self-reported symptoms via scales such as the DASS-21. As we will have continuous algorithm output, we complete a correlation/regression analysis.

5. General demographic questions - factors such as age and gender will be analysed with ordinary parametric tools.

6. User acceptability, feedback response and comfort ratings will be collected through questions embedded in the App.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment postcode(s) [1] 12690 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 292808 0
Commercial sector/Industry
Name [1] 292808 0
Medibio Ltd
Address [1] 292808 0
Medibio Ltd.
Suite 605, Level 6
50 Clarence Street
Sydney NSW 2000
[GPO Box 4492, Sydney NSW 2001]
Country [1] 292808 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medibio Ltd
Address
Medibio Ltd.
Suite 605, Level 6
50 Clarence Street
Sydney NSW 2000
[GPO Box 4492, Sydney NSW 2001]
Country
Australia
Secondary sponsor category [1] 291546 0
None
Name [1] 291546 0
None
Address [1] 291546 0
Country [1] 291546 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294308 0
Bellberry
Ethics committee address [1] 294308 0
129 Glen Osmond Road
Eastwood
South Australia 5063
Ethics committee country [1] 294308 0
Australia
Date submitted for ethics approval [1] 294308 0
03/02/2016
Approval date [1] 294308 0
Ethics approval number [1] 294308 0

Summary
Brief summary
According to the most recent Stress and Wellbeing Survey, 35% of Australians experience a significant level of distress in their lives and just over a quarter report having moderate to extremely severe depression symptoms. Unfortunately, the majority of sufferers do not seek help for their stress. When they do, Australians are tend to approach family and friends, and only 15% report seeking help from a psychologist or other mental health specialist. Some of the reluctance to engage in help-seeking is related to the stigma of the perception of not coping, whilst some is also related to the perception of malingering or feigning illness.
There is a key issue in this context. Whilst the use of pen and paper/technology based questionnaires is commonplace to screen for stress there are concerns over their false positive rate and predictive ability. Measures of heart rate variability (HRV), the beat-to-beat temporal changes in the heart rate (HR), may provide an alternative for stress assessment. These beat-to-beat changes are commonly used as a quantitative marker depicting the activity of the autonomic nervous system (ANS), thus related to mental stress. It has been suggested that changes in HR over 24 hours, or circadian heart rate (CHR) changes, may present adjunct information for stress assessment as circadian dysregulation is present in varying degrees in all psychiatric illnesses. As such, it has been proposed that HR profiling algorithms might provide an objective and predictive measure of stress and inform the likelihood of stress becoming a clinical illness.
This study aims to assess whether a currently available HR monitoring device, worn over 24 hours, thus measuring CHR, can provide objective indications of stress. CHR will be monitored 4 times: twice in the first week and twice again after 2-3 weeks. Measures of CHR will be compared with data obtained from self-report measures to evaluate consistency of results and cross-sectional and predictive validity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63242 0
Dr Michael Player
Address 63242 0
Medibio Ltd
MLC Centre
Suite 36, Level 56
19-29 Martin Place,
Sydney, NSW 2000
Country 63242 0
Australia
Phone 63242 0
+61 419 906 999
Fax 63242 0
Email 63242 0
michael.player@sydney.edu.au
Contact person for public queries
Name 63243 0
Dr Michael Player
Address 63243 0
Medibio Ltd
MLC Centre
Suite 36, Level 56
19-29 Martin Place,
Sydney, NSW 2000
Country 63243 0
Australia
Phone 63243 0
+61 419 906 999
Fax 63243 0
Email 63243 0
michael.player@sydney.edu.au
Contact person for scientific queries
Name 63244 0
Dr Michael Player
Address 63244 0
Medibio Ltd
MLC Centre
Suite 36, Level 56
19-29 Martin Place,
Sydney, NSW 2000
Country 63244 0
Australia
Phone 63244 0
+61 419 906 999
Fax 63244 0
Email 63244 0
michael.player@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results