Smartphone-based virtual agents and insomnia management: A proof-of-concept study for new methods of autonomous screening and management of insomnia symptoms in the general population.

Insomnia is the most frequent sleep disorder, and the COVID-19 crisis has massively increased its prevalence in the population, due to psychosocial stress or direct viral contamination. KANOPEE_2 is a smartphone-based application that provides interactions with a virtual agent to autonomously screen and alleviate insomnia symptoms through an intervention programme giving personalized advices regarding sleep hygiene, relaxation techniques and stimulus-control. In this proof-of-concept study, we tested the effects of KANOPEE_2 among users from all over the country (France) who downloaded the app between 1 June and 26 October 2020 (to focus on effects after the end of COVID-19 confinement). Outcome measures include insomnia severity (Insomnia Severity Index) and sleep/wake schedules measured by a sleep diary. One-thousand and thirty-four users answered the screening interview (Mage  = 43.76 years; SD = 13.14), and 108 completed the two-step programme (Mage  = 46.64 years; SD = 13.63). Of those who answered the screening, 42.8% did not report sleep complaints, while 57.2% presented mild-to-severe insomnia symptoms. At the end of the intervention, users reported significantly fewer sleep complaints compared with the beginning of the intervention (Insomnia Severity Indexbeginning  = 13.58; Insomnia Severity Indexend  = 11.30; p < 0.001), and significantly increased their sleep efficiency (sleep efficiencybeginning  = 76.46%; sleep efficiencyend  = 80.17%; p = 0.013). KANOPEE_2 is a promising solution both to provide autonomous evaluation of individuals' sleep hygiene and reduce insomnia symptoms over a brief and simple intervention. These results are very encouraging for addressing the issue of insomnia management in people exposed to major psychosocial stress and the consequences of COVID-19 infection.

Symptom network analysis of the sleep disorders diagnostic criteria based on the clinical text of the ICSD-3.

The third edition of the International Classification of Sleep Disorders (ICSD-3) is the authoritative clinical text for the diagnosis of sleep disorders. An important issue of sleep nosology is to better understand the relationship between symptoms found in conventional diagnostic manuals and to compare classifications. Nevertheless, to our knowledge, there is no specific exhaustive work on the general structure of the networks of symptoms of sleep disorders as described in diagnostic manuals. The general aim of the present study was to use symptom network analysis to explore the diagnostic criteria in the ICSD-3 manual. The ICSD-3 diagnostic criteria related to clinical manifestations were systematically identified, and the units of analysis (symptoms) were labelled from these clinical manifestation diagnostic criteria using three rules ("Conservation", "Splitting", "Lumping"). A total of 37 of the 43 main sleep disorders with 160 units of analysis from 114 clinical manifestations in the ICSD-3 were analysed. A symptom network representing all individual ICSD-3 criteria and connections between them was constructed graphically (network estimation), quantified with classical metrics (network inference with global and local measures) and tested for robustness. The global measure of the sleep symptoms network shows that it can be considered as a small world, suggesting a strong interconnection between symptoms in the ICSD-3. Local measures show the central role of three kinds of bridge sleep symptoms: daytime sleepiness, insomnia, and behaviour during sleep symptoms. Such a symptom network analysis of the ICSD-3 structure could provide a framework for better systematising and organising symptomatology in sleep medicine.

Acceptance of virtual agents in a homecare context: Evaluation of excessive daytime sleepiness in apneic patients during interventions by continuous positive airway pressure (CPAP) providers.

Sleep apnea syndrome treatment relies primarily on continuous positive airway pressure, which requires a homecare follow-up. Excessive daytime sleepiness is a key symptom to be measured during follow-up, and there is a need for more easy-to-administer, ecological and engaging tools to assess it. Virtual agents have shown their effectiveness in performing clinical evaluation in a medical environment. A virtual agent assessing excessive daytime sleepiness via the Epworth Sleepiness Scale has been tested at home by 102 patients treated by continuous positive airway pressure (CPAP) and their homecare providers. Acceptance and trustworthiness of the agent, as well as the influence of demographics and clinical characteristics of patients, were investigated. Results showed that both patients and homecare providers reported a positive attitude towards the virtual agent, which was found to be usable, satisfactory, credible and benevolent. Homecare providers reported that it was not a burden to their working routine. Positive regression coefficients were found between patients' and homecare providers' attitudes towards the virtual agent. We found no influence of patients' demographics and clinical characteristics on their acceptance of the virtual agent. This shows that virtual agents are well accepted by patients and homecare providers, independently of their demographics and clinical characteristics. Positive regression coefficients observed between patients' and homecare providers' perceptions of the agent indicate that the opinions of both influence acceptance of the virtual agent in a homecare context. Virtual agents are new innovative digital solutions to be considered in homecare follow-up of apneic patients treated by CPAP.

Factors associated with serious vehicular accidents: A cross-sectional study in hospital emergency rooms.

AIMS: Pictograms on medicine boxes warn of potential drug-related driving hazard; we studied their association with serious accidents. METHODS: Prospective study in emergency departments of the hospitals in Bordeaux and Périgueux (France), of drivers with serious (admitted at least 24 hours) or nonserious vehicular accidents. Minors, passengers, pedestrians or subjects incapable of answering an interview were excluded. Interviews ascertained driver and accident characteristics, use of drugs with or without pictograms, use of alcohol and abuse substances, sleepiness, distractions, and mind wandering at the time of the accident, RESULTS: Between 18 October 2016 and 26 December 2018, 1200 of the 6212 drivers admitted to the hospital emergency rooms, 741 nonserious, 459 serious, were interviewed. Serious accidents were associated with male sex (odds ratio 1.89, 95% confidence interval [1.36-2.64]), age above 60 years (3.64 [2.21-6.00]), driving on local roads (3.34 [2.34-4.76]), driving a motorcycle (3.39 [2.29-5.00]), having drunk alcohol within 6 hours (2.89 [1.85-4.51]) and using a drug with a pictogram during the 24 hours previous to the accident (1.57 [1.06-2.32]). From 207 police reports, 101 drivers were not responsible, and 106 were responsible, associated with age below 40 years, driving in overcast or rainy weather (2.62 [1.29-5.33]), on local roads (3.89 [1.90-7.95]), and use of at least 1 pictogram drug in the previous week (3.12 [1.31-7.41]). CONCLUSION: The known risks of alcohol and pictogram drugs, of riding motorcycles and using local roads were confirmed. As measured, behavioural sleepiness did not predict accidents.

Insomnia does not affect heart rate changes when young adults watch humorous films: An exploratory study.

Emotional reactivity in insomnia is affected both subjectively and on a physiological level for negative emotional material, but little is known about reactions to positive stimuli. We here investigated whether in younger adult insomnia patients, presentation of short humorous films would lead to heart rate decreases during and after film viewing, as compared to heart rate changes when falling asleep. Investigating 20 participants with DSM-5-diagnosed insomnia and 18 participants without insomnia, we found that heart rate decreased when falling asleep, increased when watching humorous films and returned to normal values afterwards for all participants. Film-related heart rate increases were strongly related to humour ratings of the films. No differences were found between those with and without insomnia on subjective ratings of the films, film-related heart rate changes or when falling asleep. We conclude that the experience of positive daily life stimuli in younger adults is not affected by insomnia in our study, despite insomnia having a known more profound effect on negative stimuli. Future studies exploring insomnia-related autonomous nervous system responses combining different neurophysiological modalities should confirm our findings.

Altered sleep quality is associated with Crohn's disease activity: an actimetry study.

BACKGROUND: Sleep is involved in the regulation of inflammation, healing, and digestion. The pathophysiology of Crohn's disease (CD) is unclear, and the role of sleep disturbances has recently been suggested. OBJECTIVE: The present study investigated a putative association between sleep disturbances and CD activity. METHODS: We conducted a prospective observational monocenter translational study, recruiting major CD patients from 2013 to 2015. Disease activity was assessed by the Harvey-Bradshaw index and the CD activity index. Objective sleep quantity and quality were measured by wrist actigraphy over a period of 7 days. The primary objective was to look for an association between wrist actigraphy parameters and CD activity. RESULTS: Thirty-four CD patients, including 14 with active disease and 20 in remission, were included. Sleep efficiency measured by wrist actigraphy was lower in patients with active CD compared to patients in remission. Wake after sleep onset time best predicted CD activity with an AUROC of 0.83. Patients with active CD were more frequently characterized as "poor sleepers" and frequently suffered from excessive daytime sleepiness. CONCLUSION: Sleep efficiency is lower in patients with active CD than in those in remission. Further studies aimed at better characterizing CD patients' sleep are warranted.

Smartphone-Based Virtual Agents to Help Individuals With Sleep Concerns During COVID-19 Confinement: Feasibility Study.

BACKGROUND: The COVID-19 crisis and consequent confinement restrictions have caused significant psychosocial stress and reports of sleep complaints, which require early management, have increased during recent months. To help individuals concerned about their sleep, we developed a smartphone-based app called KANOPEE that allows users to interact with a virtual agent dedicated to autonomous screening and delivering digital behavioral interventions. OBJECTIVE: Our objective was to assess the feasibility of this app, in terms of inclusion rate, follow-up rate, perceived trust and acceptance of the virtual agent, and effects of the intervention program, in the context of COVID-19 confinement in France. METHODS: The virtual agent is an artificial intelligence program using decision tree architecture and interacting through natural body motion and natural voice. A total of 2069 users aged 18 years and above downloaded the free app during the study period (April 22 to May 5, 2020). These users first completed a screening interview based on the Insomnia Severity Index (ISI) conducted by the virtual agent. If the users were positive for insomnia complaints (ISI score >14), they were eligible to join the 2-stage intervention program: (1) complete an electronic sleep diary for 1 week and (2) follow personalized sleep recommendations for 10 days. We collected and analyzed the following measures: sociodemographic information, ISI scores and sleep/wake schedules, and acceptance and trust of the agent. RESULTS: Approximately 76% (1574/2069) of the app users completed the screening interview with the virtual agent. The virtual agent was well accepted by 27.4% (431/1574) of the users who answered the acceptance and trust questionnaires on its usability, satisfaction, benevolence, and credibility. Of the 773 screened users who reported sleep complaints (ISI score >14), 166 (21.5%) followed Step 1 of the intervention, and only 47 of those (28.3%) followed Step 2. Users who completed Step 1 found that their insomnia complaints (baseline mean ISI score 18.56, mean ISI score after Step 1 15.99; P<.001) and nocturnal sleep quality improved significantly after 1 week. Users who completed Step 2 also showed an improvement compared to the initial measures (baseline mean ISI score 18.87, mean ISI score after Step 2 14.68; P<.001). Users that were most severely affected (ISI score >21) did not respond to either intervention. CONCLUSIONS: These preliminary results suggest that the KANOPEE app is a promising solution to screen populations for sleep complaints and that it provides acceptable and practical behavioral advice for individuals reporting moderately severe insomnia.

Event-Related Electrodermal Response to Stress: Results From a Realistic Driving Simulator Scenario.

OBJECTIVE: The study goal was to test whether induced stress during driving could be measured at the event level through electrodermal activity responses. BACKGROUND: Stress measured in simulation scenarios could thus far show an overall change in the stress state, but not be well attributed to acute stressful events. Driving simulator scenarios that induce stress measurable at the event level in realistic situations are thus warranted. As such, acute stress reactions can be measured in the context of changing situational factors such as fatigue, substance abuse, or medical conditions. METHOD: Twelve healthy female participants drove the same route numerous times in a driving simulator, each time with different random traffic events occurring throughout. During one of the scenarios, unknown to the participants, 10 programmed neutral traffic events occurred, whereas in another scenario, at the same location, 10 stressful events occurred. RESULTS: Electrodermal response results showed both effects of scenario type and of events. The amplitude of the electrodermal response was significantly correlated with subjective stress experience. CONCLUSION: We conclude that our developed ecological driving simulation scenarios can be used to induce and measure stress at the event level. APPLICATION: The developed simulator scenarios enable us to measure stress reactions in driving situations at the time when the event actually happens. With these scenarios, we can measure how situational factors, such as fatigue or substance abuse, can change immediate stress reactions when driving. We can further measure more specifically how induced driving stress can affect physical and mental functioning afterward.

How sleep problems contribute to simulator sickness: Preliminary results from a realistic driving scenario.

Virtual reality and simulation tools enable us to assess daytime functioning in environments that simulate real life as close as possible. Simulator sickness, however, poses a problem in the application of these tools, and has been related to pre-existing health problems. How sleep problems contribute to simulator sickness has not yet been investigated. In the current study, 20 female chronic insomnia patients and 32 female age-matched controls drove in a driving simulator covering realistic city, country and highway scenes. Fifty percent of the insomnia patients as opposed to 12.5% of controls reported excessive simulator sickness leading to experiment withdrawal. In the remaining participants, patients with insomnia showed overall increased levels of oculomotor symptoms even before driving, while nausea symptoms further increased after driving. These results, as well as the realistic simulation paradigm developed, give more insight on how vestibular and oculomotor functions as well as interoceptive functions are affected in insomnia. Importantly, our results have direct implications for both the actual driving experience and the wider context of deploying simulation techniques to mimic real life functioning, in particular in those professions often exposed to sleep problems.

A French update on the Self-Efficacy Measure for Sleep Apnea (SEMSA) to assess continuous positive airway pressure (CPAP) use.

PURPOSE: The Self-Efficacy Measure for Sleep Apnea (SEMSA) is a 26-item self-questionnaire composed of three factors: risk perception of obstructive sleep apnea syndrome (OSAS), benefit of continuous positive airway pressure (CPAP), and self-efficacy (the confidence to engage in CPAP use). It is used to evaluate health beliefs about OSAS and CPAP in order to optimize CPAP use. The purpose of this study was to design and validate a French version of the SEMSA. METHODS: A forward-backward translation of the SEMSA was performed. Subjects with OSAS treated by CPAP and followed by our sleep clinic were invited to complete the questionnaire. The psychometric properties of the French SEMSA version were analyzed in terms of its construct validity (with confirmatory factor analysis, CFA), internal structural validity (Cronbach's alpha coefficient), and external validity (Pearson's correlation between SEMSA score and duration of CPAP use). RESULTS: Two hundred eighty-eight subjects filled in the questionnaire. The mean age was 63.16 ± 12.73 years. The number of years since the beginning of CPAP treatment was 6.58 ± 6.03 years. The mean CPAP use duration was 6.19 ± 2.03 h/night. CFA was unsatisfactory (RMSEA = 0.066 and CFI = 0.88). The exploratory factor analysis revealed a fourth factor named "cardiovascular risk" factor. Cronbach's alpha coefficient was 0.886. The correlation between the "self-efficacy" factor and the duration of CPAP use was significant (r = 0.26, p ≤ 0.001). CONCLUSIONS: The French version of the SEMSA is a psychometrically acceptable self-report questionnaire for measuring health beliefs and behavior in French patients with OSAS treated with CPAP. Such translation and validation should lead to the adoption of validated psychosocial methods for improving CPAP use.

Development of a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination.

INTRODUCTION: A new approach to treat obstructive sleep apnea (OSA) is upper airway stimulation therapy (UAS). Electrical pulses applied to the hypoglossal nerve induce tongue protrusion, increase airway patency and decrease the frequency of apneic and hypopneic events. Thus, the main objective of this study was to design a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination. METHOD: This study has designed the Tongue Adverse Event and Satisfaction Questionnaire (TAESQ) and an endobuccal examinations divided into an endobuccal lesion examination (ELE) and an endobuccal risk factor examination (ERFE). Evaluations were conducted at month 6 post-implantation. RESULTS: The study population after implantation of UAS device consisted of ten Caucasian males with a mean age of 51.9 ± 11.8 years, and a mean BMI of 28.6 ± 3.3. The AHI of the ten participants ranged from 46.7 ± 12.2/h at baseline to 14.5 ± 8.9/h with the Inspire therapy at the 6-month follow-up. The TAESQ revealed pain (30%), followed by less tongue sensitivity (20%) and tongue weakness (10%). The ELE did not reveal any lesions. The ERFE revealed that some participants had tissue and dental risk factors but not associated to more adverse events. CONCLUSION: The TAESQ, ELE and ERFE have been designed and studied on a small number of participants. These evaluations could systematically be included in the care pathway of patients treated by UAS to better investigate tongue discomfort and tongue lesion for patients treated with this technology.

Towards a Pragmatic Approach to a Psychophysiological Unit of Analysis for Mental and Brain Disorders: An EEG-Copeia for Neurofeedback.

This article proposes what we call an "EEG-Copeia" for neurofeedback, like the "Pharmacopeia" for psychopharmacology. This paper proposes to define an "EEG-Copeia" as an organized list of scientifically validated EEG markers, characterized by a specific association with an identified cognitive process, that define a psychophysiological unit of analysis useful for mental or brain disorder evaluation and treatment. A characteristic of EEG neurofeedback for mental and brain disorders is that it targets a EEG markers related to a supposed cognitive process, whereas conventional treatments target clinical manifestations. This could explain why EEG neurofeedback studies encounter difficulty in achieving reproducibility and validation. The present paper suggests that a first step to optimize EEG neurofeedback protocols and future research is to target a valid EEG marker. The specificity of the cognitive skills trained and learned during real time feedback of the EEG marker could be enhanced and both the reliability of neurofeedback training and the therapeutic impact optimized. However, several of the most well-known EEG markers have seldom been applied for neurofeedback. Moreover, we lack a reliable and valid EEG targets library for further RCT to evaluate the efficacy of neurofeedback in mental and brain disorders. With the present manuscript, our aim is to foster dialogues between cognitive neuroscience and EEG neurofeedback according to a psychophysiological perspective. The primary objective of this review was to identify the most robust EEG target. EEG markers linked with one or several clearly identified cognitive-related processes will be identified. The secondary objective was to organize these EEG markers and related cognitive process in a psychophysiological unit of analysis matrix inspired by the Research Domain Criteria (RDoC) project.

Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea.

PURPOSE: Selective upper-airway stimulation (UAS) is a novel therapy for patients with obstructive sleep apnea (OSA). The aim of this study was to compare changes in sleep architecture during the diagnostic polysomnography and the post-implantation polysomnography in UAS in patients with OSA. METHODS: Twenty-six patients who received a UAS device (Inspire Medical Systems) were included. Treatment outcome was evaluated 2 and 3 months after surgery. Data collection included demographics, body mass index (BMI), apnea hypopnea index (AHI), oxygen saturation and desaturation index (ODI), Epworth sleepiness score (ESS), arousal parameter, and sleep patterns. RESULTS: The mean age was 60.2 years, 25 patients were male, 1 patient was female. Mean BMI was 29.0 kg/m2. The mean pre-implantation AHI of 33.9/h could be reduced to 9.1/h at 2 months post-implantation (p < 0.001). The amount of time spent in N1-sleep could be reduced from 23.2% at baseline to 16.0% at month 3 post-implantation. The amount of time spent in N2- and N3-sleep did not change during the observation period. A significant increase of the amount of REM sleep at month 2 (15.7%) compared to baseline (9.5%; p = 0.010) could be observed. A reduction of the number of arousals and the arousal index could be observed. CONCLUSION: In conclusion, significant changes in sleep architecture of patients with OSA and sufficient treatment with UAS could be observed. A reduction of the amount of time spent in N1-sleep could be caused by treatment with UAS and the rebound of REM sleep, observed for the first time in a study on UAS, is also a potential marker of the efficacy of UAS on sleep architecture. TRIAL REGISTRATION: NCT02293746.

[Virtual doctors and e-health]. / Médecins virtuels et e-santé.

One of the challenges of e-health will be to give concrete form to personalised therapeutic solutions using connected objects, information and decision-making systems, and patient management behavioural programmes. Developed to improve the empathetic relationship with patients, virtual companions are the subject of research programmes.

Excessive daytime sleepiness in patients with ADHD--diagnostic and management strategies.

The links between attention-deficit hyperactivity disorder (ADHD) and sleep disorders remain unclear. Specific sleep disorders are a frequent comorbid condition associated with ADHD according to a categorical approach. However, sleep disorders can also induce ADHD-like symptoms according to a dimensional approach and are thought to be the consequence of excessive daytime sleepiness. It may thus be difficult for clinicians to differentiate the diagnosis of ADHD comorbid with a sleep disorder from sleep disorders with ADHD-like symptoms. This distinction could be important for the appropriate management of patients with dual complaints of trouble maintaining attention and daytime sleepiness. This paper summarizes the main sleep disorders associated with ADHD: sleep-related breathing disorders, sleep-related movement disorders, circadian rhythm sleep-wake disorders, and central disorders of hypersomnolence (aka hypersomnias). The history of presenting symptoms should be taken into account since ADHD is a neurodevelopmental disorder whereas ADHD symptoms comorbid with sleep disorder are not. Finally, we propose a model to clarify the links between ADHD, ADHD symptoms, and excessive daytime sleepiness induced by sleep disorders. Clinicians should therefore routinely assess, monitor, and manage the sleep problems of patients with ADHD who have both comorbidities and should search for the presence of ADHD symptoms in subjects with sleep disorders.

Insomnia and accidents: cross-sectional study (EQUINOX) on sleep-related home, work and car accidents in 5293 subjects with insomnia from 10 countries.

The link between sleepiness and the risk of motor vehicle accidents is well known, but little is understood regarding the risk of home, work and car accidents of subjects with insomnia. An international cross-sectional survey was conducted across 10 countries in a population of subjects with sleep disturbances. Primary care physicians administered a questionnaire that included assessment of sociodemographic characteristics, sleep disturbance and accidents (motor vehicle, work and home) related to sleep problems to each subject. Insomnia was defined using the International Classification of Sleep Disorders (ICSD-10) criteria. A total of 5293 subjects were included in the study, of whom 20.9% reported having had at least one home accident within the past 12 months, 10.1% at least one work accident, 9% reported having fallen asleep while driving at least once and 4.1% reported having had at least one car accident related to their sleepiness. All types of accident were reported more commonly by subjects living in urban compared to other residential areas. Car accidents were reported more commonly by employed subjects, whereas home injuries were reported more frequently by the unemployed. Car accidents were reported more frequently by males than by females, whereas home accidents were reported more commonly by females. Patients with insomnia have high rates of home accidents, car accidents and work accidents related to sleep disturbances independently of any adverse effects of hypnotic treatments. Reduced total sleep time may be one factor explaining the high risk of accidents in individuals who complain of insomnia.