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Validation Of A Circadian Heart Rate Monitoring Device For Use To Measures Stress Levels In A Convenience Sample of Healthy Adults

Validation Of A Circadian Heart Rate Monitoring Device For Use To Measures Stress Levels In A Convenience Sample of Healthy Adults

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000128493
Enrollment
300
Registered
2016-02-04
Start date
2016-03-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

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 wil

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.

Sponsors

Medibio Ltd
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026