Chronic InsomniaREFIRENCT06251258
Facial Emotion Recognition in Insomnia and Emotional Regulation
A study testing Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) in people with Chronic Insomnia, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Insomnia group: ISI >14 (between 15 and 28 = clinical insomnia)
- Control group: ISI < 8 (between 0 and 7 = no insomnia)
- Non-pre-inclusion criteria
- Known psychiatric disorders (Characterized depressive episode, Bipolar disorder, Schizophrenia and other delusional disorders, Specified anxiety disorder (social anxiety, generalized anxiety disorder), Obsessive-compulsive disorder (OCD), Eating disorders, Neurodevelopmental disorders (ASD, ADHD), Active addictive disorders (excluding tobacco), ...)
- Taking antidepressant, neuroleptic or thymoregulator medication
- Taking a benzodiazepine with a long half-life (>12 hours)
Show all 16Show fewer
- Condition requiring hospitalization in the month preceding the study
- Known sequelae or progressive neurological disease
- Known significant ophthalmological condition
- Pregnancy or breast-feeding
- Person deprived of liberty by judicial or administrative decision
- Person subject to a legal protection measure
- Person under psychiatric care without consent
- For control group: no known insomnia
- Non-inclusion criteria :
- Psychiatric disorders identified during psychiatric interview
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49033
Bénédicte Gohier, 0241353243, begohier@chu-angers.fr
About this study
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.
Read more
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-deficit/hyperactivity 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 study's 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 study's outcomes could guide the development of specific rehabilitation programs centered on facial emotion recognition, emotional deficits, and emotional dysregulation in insomnia.
Read the 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 hospital's 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: controls/1: insomnia), and inclusion number (e.g., 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).
- Conditions
- Chronic Insomnia
- Being tested
- Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ)
- Keywords
- chronic insomnia, neuropsychology, facial expression assessment, emotional regulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ)Diagnostic test
Facial emotion recognition test without eye-tracking (explicit test, without time limit) and facial emotion recognition test with eye tracking (implicit test, with observation of fixation points)
| Study group | Role | What they receive |
|---|---|---|
| Insomnia | Experimental | Not described Receives: Diagnostic Test: Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) |
| Control | Active comparator | Not described Receives: Diagnostic Test: Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial emotion recognition test (TREF test) in insomnia and control
The error rate on facial recognition test (in percent)
Measured: 10 minutes
Facial emotion recognition test (TREF test) in insomnia and control
The intensity of the emotion on facial recognition test (in percent)
Measured: 10 minutes
Facial emotion recognition test (TREF test) in insomnia and control
Response time on facial recognition test (in second)
Measured: 10 minutes
Secondary outcomes (7)
Attentional bias
Measurement of errors rate on facial recognition test (TREF test) with eye-tracking dispositif (in percent)
Measured: 10 minutes
Attentional bias
Intensity of the recognized emotion on facial recognition test in eye-tracking (in percent)
Measured: 10 minutes
Attentional bias
Measurement of first fixation duration on facial recognition test in eye-tracking (in second)
Measured: 10 minutes
Attentional bias
Measurement of duration of fixation on eyes (of face photography in the test) on facial recognition test in eye-tracking
Measured: 10 minutes
Attentional bias
Measurement of duration of fixation on nose (of face photography in the test) on facial recognition test in eye-tracking
Measured: 10 minutes
Attentional bias
Measurement of duration of fixation on mouth (of face photography in the test) on facial recognition test in eye-tracking
Measured: 10 minutes
Emotional dysregulation bias
Cognitive Emotional Regulation Questionnaire (CERQ) test. The CERQ is made up of 36 assertions with multiple related propositions i.e. "almost never, sometimes, regularly, often, almost always" corresponding to a score between 1 and 5. It identifies two main types of emotional regulation strategy profile according to the scores obtained on the various questions, each ranging from 4 to 20 : measures adaptive regulation (sub-types: acceptance, positive centering, action centering, positive re-evaluation, perspective-taking) and non-adaptive regulation (sub-types: self-blame, rumination, catastrophism, blaming others).
others).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start12 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251258
- Sponsor's protocol ID
- 2023-A02559-36
- Acronym
- REFIRE
- Status last verified
- Mar 2026
- First submitted
- 16 Jan 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Emotion Recognition in Insomnia and Emotional Regulation
- ClinicalTrials.gov ID
- NCT06251258
- Acronym / sponsor ID
- REFIRE / 2023-A02559-36
- Conditions
- Chronic Insomnia
- Keywords
- chronic insomnia, neuropsychology, facial expression assessment, emotional regulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-deficit/hyperactivity 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 study's 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 study's 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 hospital's 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: controls/1: insomnia), and inclusion number (e.g., 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia | Experimental | Diagnostic Test: Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) |
| Control | Active comparator | Diagnostic Test: Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Insomnia group: ISI >14 (between 15 and 28 = clinical insomnia)
- Control group: ISI < 8 (between 0 and 7 = no insomnia)
- Non-pre-inclusion criteria
- Known psychiatric disorders (Characterized depressive episode, Bipolar disorder, Schizophrenia and other delusional disorders, Specified anxiety disorder (social anxiety, generalized anxiety disorder), Obsessive-compulsive disorder (OCD), Eating disorders, Neurodevelopmental disorders (ASD, ADHD), Active addictive disorders (excluding tobacco), ...)
- Taking antidepressant, neuroleptic or thymoregulator medication
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ)Facial emotion recognition test without eye-tracking (explicit test, without time limit) and facial emotion recognition test with eye tracking (implicit test, with observation of fixation points) | Diagnostic test | Control, Insomnia |
Primary outcome
Facial emotion recognition test (TREF test) in insomnia and control
Time frame: 10 minutes
The error rate on facial recognition test (in percent)
Facial emotion recognition test (TREF test) in insomnia and control
Time frame: 10 minutes
The intensity of the emotion on facial recognition test (in percent)
Facial emotion recognition test (TREF test) in insomnia and control
Time frame: 10 minutes
Response time on facial recognition test (in second)
7 secondary outcomes
Attentional bias
Time frame: 10 minutes
Attentional bias
Time frame: 10 minutes
Attentional bias
Time frame: 10 minutes
Attentional bias
Time frame: 10 minutes
Attentional bias
Time frame: 10 minutes
Attentional bias
Time frame: 10 minutes
Emotional dysregulation bias
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial emotion recognition test with and without eye-tracking and Cognitive Emotion Regulation. Questionnaire (CERQ) in people with Chronic Insomnia, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benedicte GOHIER (02 41 35 32 44, BeGohier@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial emotion recognition test (TREF test) in insomnia and control (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.