BlueSkeye AI receives approval to begin clinical trials
Nottingham based AI startup BlueSkeye AI has been given approval by the Medical and Healthcare products Regulatory Agency ( MHRA) to begin clinical trials of its TrueBlue perinatal mental health App. The app uses artificial intelligence to scan peoples’ faces and voices and can identify and monitor signs of depression.
The trial, which is being conducted in partnership with the Institute of Mental Health, is designed to establish that the app is safe to use by women during and immediately after pregnancy. The trial will assess how acceptable and useable the app is in real life; and how closely the AI mood assessment agrees with standard clinical measures of depression.
The trial, which is planned to start in early 2024, is taking place in Nottingham and Nottinghamshire. It will last 14 months and involve 125 participants over the age of 18.
Women from different stages in their pregnancy are being sought to take part. The participants will be recruited through the NHS by Nottinghamshire Healthcare NHS Foundation Trust (NHFT) and Nottingham University Hospitals (NUH).
Participants will complete at least two, five-minute tasks once each week for the 12 weeks of the study. These tasks will involve reading or speaking to the app whilst it records the user’s face and voice. In addition they will regularly complete a number of well-established mental health self-report questionnaires. This will allow BlueSkeye to establish how well the app assesses and depression compared to the current best practice, questionnaire driven, methods.
The trial is divided into two phases.
An initial pilot phase will take five months and involve 12 women, who are deemed to be at the lowest levels of risk of depression. The aim of the pilot stage is to ensure the app is safe and easy to use.
This will be followed by a second phase lasting nine months with a further 113 participants. This will gather more detailed data about the safety and usability of the app.
The app is not anticipated to pose a high risk to people’s mental health. However, the trial includes support for women who experience instances of severe depression during the trial.
Professor Michel Valstar, Founding CEO of BlueSkeye AI said,
“We believe that this trial is the first of its kind in the UK and has the potential to make a major contribution to tackling the UK’s mental health crisis which is particularly acute in maternal mental health.
One in five pregnant women suffer from a mental health problem during their pregnancy and many struggle to access support. The cost of a lack of timely access to good quality perinatal mental health care costs the NHS £1.2 billion and wider UK society £8.1bn a year.
TrueBlue has the potential to help the NHS offer maternal mental health care more quickly, more effectively and more efficiently making a real difference to the lives of over 800,000 pregnant women.’
Chief Investigator, , Dr Neil Nixon, Associate Professor in Psychiatry at the University of Nottingham and Consultant Lead for the Nottingham Specialist Depression Service said,
"This is an important trial, assessing the potential for artificial intelligence to detect early indications of perinatal depression. Our partners, including expert patients and clinicians, continue to shape the development of this technology so that positive results will also translate into more effective NHS care.
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For more information:
Simon Kirby
Director of Marketing and Communications
BlueSkeye AI
Mobile: +44 7768 291053
Email: simon@blueskeye.com
