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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000128493
• Date of registration: 04/02/2016
• Prospective Registration: Yes
• Primary sponsor: Medibio Ltd
• 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
• Date of first enrolment: 01/03/2016
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616000128493.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Convenience sample;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Michael Player

• Name: Dr Michael Player

Key inclusion & exclusion criteria

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


Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Stress;
Stress

Mental Health - Other mental health disorders

Intervention(s)

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.

Primary Outcome(s)

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. [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(s)

Emotional resilience assessed using the Brief Resilience Scale (Smith et al., 2008)[At baseline and 3 week follow-up]

Participant’s current emotional wellbeing assessed using the Warwick-Edinburgh Mental Well-being Scale (Tennant et al., 2007)[At baseline and 3 week follow-up]

Anxiety assessed using the DASS-21 (Lovibond & Lovibond, 1995)[At baseline and 3 week follow-up]

Comfort of wearing Zephyr Monitor using a 5-point Likert scale[At baseline and 3 week follow-up]

Sleeping patterns assessed using the Bergen Insomnia Scale Pallesen et al., 2008)[At baseline and 3 week follow-up]

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.[At 3 week follow-up.]

Self-report levels of stress through DASS-21 and the Perceived Stress Scale (PSS; Cohen, 1988)[At baseline and at 3 week follow-up]

Physical activity assessed using the Brief Physical activity assessment scale (Marshall et al., 2005)[At baseline and 3 week follow-up]

Mood symptoms assessed using DASS-21 (Lovibond & Lovibond, 1995)[At baseline and 3 week follow-up]

User acceptability of App assessed by 5-point Likert scale[At baseline and 3 week follow-up]

Secondary ID(s)

None

Source(s) of Monetary Support

Medibio Ltd

Ethics review

Status: Not approved
Approval date:
Contact:

Bellberry