Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-16
Brief Title:
Facial Emotion Recognition in Insomnia and Emotional Regulation
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Facial Emotion Recognition in Insomnia and Emotional Regulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFIRE
Brief Summary:
Introduction Chronic insomnia is a prevalent disorder in the general population affecting up to 20 according to French National Institute of Health and Medical Research leading to a decline in quality of life and an increased risk of developing certain psychiatric disorders notably major depressive episodes Chronic insomnia particularly when accompanied by reduced sleep duration has been associated with cognitive impairments documented in the literature such as reduced concentration working memory vigilance and certain executive functions
While some studies suggest subjective cognitive impairment in insomnia it remains inconclusive when objectively measured Individuals with chronic insomnia often report a global deterioration in social life characterized by irritability attentional difficulties asthenia and social isolation This raises questions about potential impairments in social abilities particularly in recognizing facial emotions which may be linked to the subjective complaints of reduced quality of life in individuals with insomnia
Several studies have explored facial emotion recognition in insomnia with some indicating impairments in emotion recognition or evaluation of emotion intensity Others demonstrated deficits in recognizing specific emotions such as anger or representations such as fatigue which were associated with attentional deficits and changes in visual fixation points in eye-tracking studies
However some authors found no significant association between insomnia complaints and impaired facial emotion recognition Facial emotion recognition has been studied using eye-tracking in major depressive episodes attention-deficithyperactivity disorder ADHD and autism spectrum disorders Eye-tracking studies have revealed attentional biases toward negative emotions in depression and deficits in visual attention to the eye region in autism contributing to impaired facial emotion recognition To date no study has compared facial emotion recognition abilities between individuals with insomnia and a control group considering attentional deficits and emotional dysregulation described in insomnia
Methods The study aims to compare two groups one with isolated insomnia without associated psychiatric disorders and a control group without insomnia or psychiatric disorders Patients with psychiatric or addictive disorders will be excluded based on Diagnostic and Statistical Manual of Mental Disorders version 5 DSM-V psychiatric interviews Participants aged over 65 or under 18 will also be excluded to mitigate potential biases related to dementia and cognitive alterations not related to insomnia
The insomnia group will consist of individuals seeking care at the Sleep Center of Angers University Hospital for chronic insomnia lasting more than 3 months Insomnia will be confirmed using the Insomnia Severity Index ISI with a score exceeding 15 while individuals with subclinical insomnia ISI score between 7 and 15 will be excluded The control group will have an ISI score below 7 indicating the absence of insomnia
The main objective is to determine whether facial emotion recognition differs between the insomnia and control groups Secondary objectives include assessing differences between explicit facial emotion recognition tests controlled conditions and eye-tracking tests implicit memory in both groups to evaluate attentional biases Additionally the study aims to explore differences in facial emotion recognition tests based on emotional regulation profiles adaptive or non-adaptive regulation
Expected Results The hypothesis is that facial emotion recognition under controlled conditions explicit memory will not differ between the insomnia and control groups However differences are expected in implicit memory tests eye-tracking due to the attentional deficits previously described in insomnia Additionally variations in facial emotion recognition are anticipated based on emotional regulation profiles which may influence facial emotion recognition in insomnia
The studys findings could contribute to a better understanding of cognitive complaints related to insomnia especially in the realm of social interactions by objectively assessing and specifying potential biases This research may also inform targeted therapeutic approaches particularly in cognitive-behavioral therapy focusing on cognitive remediation and restructuring Ultimately the studys outcomes could guide the development of specific rehabilitation programs centered on facial emotion recognition emotional deficits and emotional dysregulation in insomnia
While some studies suggest subjective cognitive impairment in insomnia it remains inconclusive when objectively measured Individuals with chronic insomnia often report a global deterioration in social life characterized by irritability attentional difficulties asthenia and social isolation This raises questions about potential impairments in social abilities particularly in recognizing facial emotions which may be linked to the subjective complaints of reduced quality of life in individuals with insomnia
Several studies have explored facial emotion recognition in insomnia with some indicating impairments in emotion recognition or evaluation of emotion intensity Others demonstrated deficits in recognizing specific emotions such as anger or representations such as fatigue which were associated with attentional deficits and changes in visual fixation points in eye-tracking studies
However some authors found no significant association between insomnia complaints and impaired facial emotion recognition Facial emotion recognition has been studied using eye-tracking in major depressive episodes attention-deficithyperactivity disorder ADHD and autism spectrum disorders Eye-tracking studies have revealed attentional biases toward negative emotions in depression and deficits in visual attention to the eye region in autism contributing to impaired facial emotion recognition To date no study has compared facial emotion recognition abilities between individuals with insomnia and a control group considering attentional deficits and emotional dysregulation described in insomnia
Methods The study aims to compare two groups one with isolated insomnia without associated psychiatric disorders and a control group without insomnia or psychiatric disorders Patients with psychiatric or addictive disorders will be excluded based on Diagnostic and Statistical Manual of Mental Disorders version 5 DSM-V psychiatric interviews Participants aged over 65 or under 18 will also be excluded to mitigate potential biases related to dementia and cognitive alterations not related to insomnia
The insomnia group will consist of individuals seeking care at the Sleep Center of Angers University Hospital for chronic insomnia lasting more than 3 months Insomnia will be confirmed using the Insomnia Severity Index ISI with a score exceeding 15 while individuals with subclinical insomnia ISI score between 7 and 15 will be excluded The control group will have an ISI score below 7 indicating the absence of insomnia
The main objective is to determine whether facial emotion recognition differs between the insomnia and control groups Secondary objectives include assessing differences between explicit facial emotion recognition tests controlled conditions and eye-tracking tests implicit memory in both groups to evaluate attentional biases Additionally the study aims to explore differences in facial emotion recognition tests based on emotional regulation profiles adaptive or non-adaptive regulation
Expected Results The hypothesis is that facial emotion recognition under controlled conditions explicit memory will not differ between the insomnia and control groups However differences are expected in implicit memory tests eye-tracking due to the attentional deficits previously described in insomnia Additionally variations in facial emotion recognition are anticipated based on emotional regulation profiles which may influence facial emotion recognition in insomnia
The studys findings could contribute to a better understanding of cognitive complaints related to insomnia especially in the realm of social interactions by objectively assessing and specifying potential biases This research may also inform targeted therapeutic approaches particularly in cognitive-behavioral therapy focusing on cognitive remediation and restructuring Ultimately the studys outcomes could guide the development of specific rehabilitation programs centered on facial emotion recognition emotional deficits and emotional dysregulation in insomnia
Detailed Description:
Methods Each group will undergo two facial emotion recognition tests one under controlled conditions with unlimited time explicit memory recognition and the other using eye-tracking to assess attentional biases implicit memory recognition The two groups will then be compared to determine differences in facial emotion recognition abilities between insomnia and control groups primary outcome The study will also explore the same abilities using eye-tracking considering attentional deficits and visual fixation and compare the results based on emotional regulation profiles considering the potential impact of emotional dysregulation which is more frequently described in insomnia
Data will be collected by a physician using paper-based questionnaires and entered into an anonymized database on the hospitals restricted network drive The anonymized participant code will consist of the first letter of the first name first letter of the last name group 0 controls1 insomnia and inclusion number eg JG-0-001 This research project will be conducted in collaboration with the Adult Psychiatry Service the Sleep Center and the Ophthalmology Service at Angers University Hospital and will be part of the Laboratory of Psychology of the Pays de la Loire LPPL - Research Unity 4638
Data will be collected by a physician using paper-based questionnaires and entered into an anonymized database on the hospitals restricted network drive The anonymized participant code will consist of the first letter of the first name first letter of the last name group 0 controls1 insomnia and inclusion number eg JG-0-001 This research project will be conducted in collaboration with the Adult Psychiatry Service the Sleep Center and the Ophthalmology Service at Angers University Hospital and will be part of the Laboratory of Psychology of the Pays de la Loire LPPL - Research Unity 4638
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None