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OpenTrials
Completed

NCT Number: NCT05815459

Mobile Observation Of Depression

The primary aim of this project is to test if OCOsense glasses can function as a digital phenotyping tool derived from behavioural and physiological signals related to facial expression and motion recorded using the glasses.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emteq Labs

Brighton, East Sussex, BN1 9SB, United Kingdom

About this study

Assessment of participants living with a DSM5 research diagnosis of Bipolar disorder or Major depressive disorder as well as healthy controls who will be recruited and characterised through precision phenotyping involving cross-sectional assessment of biobehavioural and physiological markers of the symptoms of depression. Correlations between objective (i.e., OCOsense glasses captured) and subjective (i.e., self-reported) symptoms of depression will be measured within as well as across diagnoses. The resulting biobehavioral clusters will form the building block of a digital phenotyping tool based upon the wider spectrum of non-verbal behaviours and physiology defined and affected by the phenotype of depression.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All participants:

  • Ability to read & understand English. This is because the majority of our questionnaires are validated in the English language only.
  • Able to walk, sit, lay and stand unaided

Clinical cases:

● ≥ 15 on the Patient health Questionnaire-9 (PhQ9) (moderate to severe depression)

Exclusion criteria

Healthy control participants:

  • Self-reported current or past history (suspected or diagnosed) of any psychiatric condition
  • <5 on the Generalised Anxiety Disorder-7 questionnaire (GAD-7)
  • <5 on the PhQ-9 (no depression)
  • Receiving medication for any psychiatric disorder (excluding fibromyalgia)

All participants:

  • < 18 years of age or >40 years of age
  • Anatomical constraints that affect fit (e.g. facial disfigurement)
  • Facial nerve damage which limits the ability to make facial expressions
  • Body Mass Index (BMI) >29.9 which we deem may affect physical mobility

Treatment and study plan

OCOsense

Device

Volunteers wear OCOsense glasses continuously during testing to monitor biobehavioural responses to tasks

Primary outcomes

  1. The demonstration of a significant association between facial expression-derived objective valence and self-reported subjective mood under controlled exposure

    Time frame: 4 hours

    Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By comparing the ratio of corrugator to zygomatic muscle activation, the OCOsense glasses will produce:

    • Objective valence at a given time (ratio/intensity of corrugator to zygomatic muscle activation at that time).
  2. The demonstration of a significant association between facial expression derived objective mood and self-reported subjective mood under controlled exposure

    Time frame: 4 hours

    Measures of facial muscular activation in the corrugator supercilli and zygomaticus major muscles. By measuring corrugator and zygomatic muscle activation, the OCOsense glasses will produce:

    • Objective mood during negatively valenced exposures, neutrally valenced exposures and positively valenced exposures described in terms of expression intensity and variability for each exposure.
  3. Identifying physical activity engagement.

    Time frame: 2 hours

    The OCOsense glasses contain Inertial Measurement Units (IMU) sensors. By detecting inertial displacement over time OCOsense will detect:

    • Movement: a measure of movement over a period of time - specifically, how much of the time period is spent (i) stationary, (ii) in motion, (iii) fidgeting, (iv) engaging with a variety of activities of daily living

Secondary outcomes

  1. Investigating the relationship between vocal prosody and self-reported subjective mood

    Time frame: 2 hours

    The OCOsense glasses contain a microphone. By detecting vocal parameters over time OCOsense will detect:

    • the nonsemantic lexical features of speech related to pitch and tone whilst participants verbally recall a positive event in their life or engage with a semi-structured diagnostic interview.

Sponsors and collaborators

Lead sponsor

Emteq Ltd

Industry

Registry information

Acronym: MOOD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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