Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544226
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
The Use of Smart Devices in Capturing Digital Biomarkers in Eating Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Novel Pilot Study Examining the Potential of Smartphones to Capture New Types of Data That Can Accurately Assess the Physiological and Psychological Health Status of an Individual With an Eating Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to explore how smart devices can be used to monitor the health of individuals with eating disorders Eating disorders are serious mental health conditions that impact both mental and physical health Effective monitoring is crucial for developing treatment plans and ensuring the safety of individuals both in hospitals and at home Currently healthcare professionals use manual methods to measure important health indicators like heart rate blood pressure and BMI These methods can be time-consuming and may not always accurately reflect a patients health due to the possibility of patients concealing the severity of their condition Furthermore monitoring at home is challenging due to the lack of professional equipment and training for caregivers With advancements in digital technology smartphones and smartwatches now have the potential to collect and analyse health data in real-time These devices can capture data on heart rate blood pressure respiratory rate and other vital signs through non-invasive methods like analysing facial and fingertip blood volume namely the photoplethysmography technology Additionally video recordings from smartphone cameras can be used to assess physical and mental health by analysing facial expressions voice patterns and physical movements By utilising these digital tools combined with validated questionnaires and tasks to assess participants psychological status and the severity of disorders this study expects to create a more efficient and accessible way for individuals with eating disorders to monitor their health at home The study will collect data from participants both in hospital settings and during outpatient care to ensure the reliability and effectiveness of these digital methods across participants with different levels of severity This comprehensive approach aims to improve early detection of health issues optimise treatment plans and ultimately enhance the quality of life for individuals with eating disorders
Detailed Description:
Eating disorders are complex mental health conditions characterised by abnormal eating habits and distressing thoughts about body weight and shape significantly impacting both mental and physical health According to the International Classification of Diseases 11th Revision feeding and eating disorders include several subtypes such as anorexia nervosa AN bulimia nervosa BN and binge eating disorder BED These subtypes often involve patterns of restrictive or excessive food intake leading to severe health issues and impairments in daily functioning
Given the rising incidence and profound impacts of eating disorders in recent years including high mortality rates and significant economic burdens there is an urgent need for innovative management strategies and more efficient triage and monitoring systems for early intervention and home-based care
For the care of individuals with eating disorders comprehensive and continuous assessment of physical and psychiatric conditions is essential As recommended by the UKs National Institute for Health and Care Excellence NICE and the Royal College of Psychiatrists key clinical markers monitored include weight loss BMI heart rate blood pressure temperature hydration status and muscular function Monitoring these markers is crucial for early detection of medical complications such as electrolyte imbalances cardiac arrhythmias and orthostatic hypotension which pose serious health risks Additionally these markers help evaluate the disorders severity guide treatment adjustments and ensure patient safety during recovery
However traditional methods used to assess these biomarkers are burdensome and time-consuming With the advancement of technology novel smart devices can efficiently detect traditional biomarkers such as heart rate and blood pressure while also exploring potential novel measures of the disease Therefore this study aims to validate and explore the potential of these technologies to provide monitoring comparable to traditional methods and to integrate collected data to generate sophisticated insights into the health status of individuals with eating disorders
According to previous research the analysis of facial information including static features and dynamic movements combined with advanced algorithms and machine learning can estimate body weight BMI parotid gland size and skin condition When voice pattern analysis is integrated with facial dynamics during the video diary entry phase and the image response task where participants share their thoughts on specific images it is expected to further assess physical and psychological states particularly when discussing sensitive topics or images such as high-calorie foods These estimations can be used to interpret the health status of individuals with eating disorders Additionally photoplethysmography PPG using smart devices can detect subtle changes in the colour spectrum induced by blood volume dynamics in facial and fingertip areas allowing for the estimation of heart rate HR blood pressure BP respiratory rate RR blood oxygen level blood glucose and body temperature This technology which has been validated in healthy subjects shows significant potential for application in patients with eating disorders who are prone to cardiovascular and respiratory issues due to physiological stress and nutritional imbalances This approach provides essential insights into their physical health status particularly given the significant impairments in muscle strength often observed in individuals with eating disorders
In addition to physical health this study will also examine psychological traits that may improve the accuracy of identifying eating disorder status This will include questionnaire-based assessments and a computerised task to measure psychological processes Specifically the 7-item Generalised Anxiety Disorder Questionnaire GAD-7 and the 9-item Patient Health Questionnaire PHQ-9 will assess anxiety and depression severity respectively while the Eating Disorder Examination Questionnaire EDE-Q will evaluate eating disorder traits including eating restraint eating concern shape concern and weight concern Adolescent versions of these questionnaires will be used for younger participants Moreover since impulsivity and cognitive control are often altered in individuals with eating disorders this study will assess these cognitive functions using an adapted Stop Signal Task SST that incorporates sensitive cues such as high-calorie food cues food-specific SST FSST This task will aid in monitoring cognitive control related to the progression of eating disorders and potentially improve the accuracy of health status assessments in these individuals
This study aims to validate the aforementioned biomarkers and models captured by the smart device and to explore changes in these biomarkers and psychological status across different stages and severities of eating disorders Data will be collected over 16 weeks from both hospitalised patients and outpatients Most data including vital and physical biomarkers facial information and self-reported anxiety and depression measures will be collected weekly either once or twice a week with adjustments for those with less frequent visits Whereas the EDE-Q the FSST task and the patient acceptance questionnaire which assesses patients acceptance of the data collection procedures will be conducted three times during the study in weeks 1 8 and 16 By conducting this study the investigators expect to enhance the usability and acceptance of non-invasive monitoring tools providing valuable insights into the health status of individuals with eating disorders
Given the rising incidence and profound impacts of eating disorders in recent years including high mortality rates and significant economic burdens there is an urgent need for innovative management strategies and more efficient triage and monitoring systems for early intervention and home-based care
For the care of individuals with eating disorders comprehensive and continuous assessment of physical and psychiatric conditions is essential As recommended by the UKs National Institute for Health and Care Excellence NICE and the Royal College of Psychiatrists key clinical markers monitored include weight loss BMI heart rate blood pressure temperature hydration status and muscular function Monitoring these markers is crucial for early detection of medical complications such as electrolyte imbalances cardiac arrhythmias and orthostatic hypotension which pose serious health risks Additionally these markers help evaluate the disorders severity guide treatment adjustments and ensure patient safety during recovery
However traditional methods used to assess these biomarkers are burdensome and time-consuming With the advancement of technology novel smart devices can efficiently detect traditional biomarkers such as heart rate and blood pressure while also exploring potential novel measures of the disease Therefore this study aims to validate and explore the potential of these technologies to provide monitoring comparable to traditional methods and to integrate collected data to generate sophisticated insights into the health status of individuals with eating disorders
According to previous research the analysis of facial information including static features and dynamic movements combined with advanced algorithms and machine learning can estimate body weight BMI parotid gland size and skin condition When voice pattern analysis is integrated with facial dynamics during the video diary entry phase and the image response task where participants share their thoughts on specific images it is expected to further assess physical and psychological states particularly when discussing sensitive topics or images such as high-calorie foods These estimations can be used to interpret the health status of individuals with eating disorders Additionally photoplethysmography PPG using smart devices can detect subtle changes in the colour spectrum induced by blood volume dynamics in facial and fingertip areas allowing for the estimation of heart rate HR blood pressure BP respiratory rate RR blood oxygen level blood glucose and body temperature This technology which has been validated in healthy subjects shows significant potential for application in patients with eating disorders who are prone to cardiovascular and respiratory issues due to physiological stress and nutritional imbalances This approach provides essential insights into their physical health status particularly given the significant impairments in muscle strength often observed in individuals with eating disorders
In addition to physical health this study will also examine psychological traits that may improve the accuracy of identifying eating disorder status This will include questionnaire-based assessments and a computerised task to measure psychological processes Specifically the 7-item Generalised Anxiety Disorder Questionnaire GAD-7 and the 9-item Patient Health Questionnaire PHQ-9 will assess anxiety and depression severity respectively while the Eating Disorder Examination Questionnaire EDE-Q will evaluate eating disorder traits including eating restraint eating concern shape concern and weight concern Adolescent versions of these questionnaires will be used for younger participants Moreover since impulsivity and cognitive control are often altered in individuals with eating disorders this study will assess these cognitive functions using an adapted Stop Signal Task SST that incorporates sensitive cues such as high-calorie food cues food-specific SST FSST This task will aid in monitoring cognitive control related to the progression of eating disorders and potentially improve the accuracy of health status assessments in these individuals
This study aims to validate the aforementioned biomarkers and models captured by the smart device and to explore changes in these biomarkers and psychological status across different stages and severities of eating disorders Data will be collected over 16 weeks from both hospitalised patients and outpatients Most data including vital and physical biomarkers facial information and self-reported anxiety and depression measures will be collected weekly either once or twice a week with adjustments for those with less frequent visits Whereas the EDE-Q the FSST task and the patient acceptance questionnaire which assesses patients acceptance of the data collection procedures will be conducted three times during the study in weeks 1 8 and 16 By conducting this study the investigators expect to enhance the usability and acceptance of non-invasive monitoring tools providing valuable insights into the health status of individuals with eating disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None