Clinical Research Directory

Brief Trial of ACT-i for Adults With Chronic Insomnia

This is a prospective, randomized-controlled trial that assesses the efficacy of a brief Acceptance and Commitment Therapy (ACT-i), compared to an attentional control group, in adults with chronic insomnia. The interventions will be evaluated for their impact on insomnia severity, cognitive function, depression, anxiety, psychological flexibility, and sleep beliefs - measured before treatment, two weeks after and at a three-month follow-up.

Facial Emotion Recognition in Insomnia and Emotional Regulation

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.

Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)

In France, the treatment of chronic insomnia relies mainly on hypnotic drugs in routine care, despite the high level of iatrogenicity. Cognitive-behavioral therapy (CBT) is recommended by the HAS as a non-pharmaceutical first-line therapy for chronic insomnia. Despite evidence of their efficacy in chronic insomnia, these therapies remain underdeveloped in France (few practitioners, time-consuming for the patient). Hypnotherapy is another non-drug intervention suitable for routine outpatient care. Among the hypnosis methods practiced in France, E2R (Emotion, Regression, Repair) is a hypnotherapy method used in general practice, particularly for chronic insomnia. To date, no clinical trials have been carried out to demonstrate its effectiveness in this pathology. The HypERR study is a multicenter, randomized, open-label study designed to evaluate the efficacy of a hypotherapy method called E2R in the management of chronic insomnia, by comparing it with standard care (without hypnosis).

Impact of Insomnia Treatment on Brain Responses During Resting-state and Cognitive Tasks

Individuals with chronic insomnia have persistent difficulty falling and staying asleep, as well as complaints of altered daytime functioning that may be associated with cognitive impairments. The neural processes underlying these daytime complaints may involve abnormal activation of brain regions and neural networks involved in working memory, memory encoding and emotions. The goal of this study is to assess whether a psychological treatment for insomnia will reverse these abnormalities in brain responses to cognitive tasks and at rest. A secondary objective of the study is to characterize impairments in attentional processing and assess if the impairments can be reversed by the psychological treatment. We hypothesized that the psychological treatment for insomnia will lead to a normalization of the brain responses to working memory, declarative memory encoding, insomnia-related stimuli, and the functional connectivity within the default-mode and limbic networks.

Brief Behavioral Therapy for Insomnia(BBTi) in Middle-aged and Older Adults With Chronic Insomnia

This study aims to investigate whether a four-week BBTi program can effectively improve chronic insomnia and reduce overall stress in middle-aged and elderly individuals.

Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study

This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.

Internet-Based Cognitive Behavioral Therapy for Insomnia in Persian-Speaking Adults

This study will test whether an internet-based cognitive behavioral therapy for insomnia (ICBT-I) delivered through the Persian-language web program "Omid" can improve sleep in Persian-speaking adults with insomnia. Participants will be adults who have problems falling or staying asleep and meet diagnostic criteria for insomnia. Those who are eligible will be randomly assigned to either receive access to the Omid web-based CBT-I program or to a wait-list control group that will receive usual care during the study period. The Omid program provides weekly online modules with educational videos and texts about sleep and insomnia, sleep hygiene, stimulus control, sleep restriction, and cognitive techniques to manage unhelpful thoughts about sleep. Participants will complete questionnaires about insomnia severity, sleep quality, and daytime sleepiness before starting the program, after finishing the intervention, and at follow-up. The main goal is to see whether the Omid ICBT-I program reduces insomnia symptoms and improves overall sleep quality compared with the wait-list control group.

Effect of Yoga in Chronic Insomnia

This study will evaluate the effect of the yoga in participants with chronic insomnia. The primary objective is to determine whether adding yoga to standard care improves insomnia severity, as measured by the Insomnia Severity Index (ISI), compared to standard care alone. The study will also assess changes in sleep architecture using polysomnography and examine dysfunctional beliefs and attitudes about sleep. Secondary objectives include evaluating the effects of yoga on stress biomarkers (salivary cortisol and salivary alpha-amylase) and on somatosensory information processing using quantitative sensory testing. These measures aim to explore possible mechanisms by which yoga may influence insomnia symptoms, including stress modulation and sensory processing changes. This assessor-blinded, randomized controlled trial will enroll 72 participants aged 18-65 years diagnosed with chronic insomnia. Participants will be randomly assigned to one of three groups: (1) Yoga + Standard Care (2) Stretching group + Standard Care (3) Standard Care alone. The yoga group and stretching group will receive an 8-week intervention (2 weeks supervised group sessions, followed by 6 weeks home practice with telemonitoring). Assessments will be performed at baseline, 2 weeks, and 8 weeks. The primary outcome is change in ISI score at 8 weeks. Secondary outcomes include polysomnographic measures, dysfunctional beliefs and attitudes about sleep, depression-anxiety-stress scores, daytime sleepiness, stress biomarker levels, and sensory thresholds

Studying the Neurobiological Mechanisms of Non-specific Chronic Low Back Pain and Chronic Insomnia: a Four-group Cross-sectional Study

This study is a part of a larger project aiming to evaluate the neurobiological mechanisms underlying the relationship between sleep and pain in people with non-specific chronic low back pain. Specifically, this study aims to evaluate the neurobiological mechanisms underlying the relationship between chronic sleep disturbances and pain sensitivity in people with non-specific chronic low back pain and chronic insomnia.

Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain

The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.

Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0

Implementing Cognitive Behavioral Therapy for Insomnia with Older Veterans (SWELL): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effectiveness of the EBP in its new context. The overall goal is to address a key priority within the implementation science field - identifying and refining metrics for equity and impact. The overall goal is to implement, evaluate, and sustain SWELL in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel CRT design.

Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Study Purpose The purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. Additionally, the study aims to explore its potential effects on memory enhancement. The primary objectives of the study are to address the following questions: * Does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia? * Does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia? Researchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia. Participant Involvement Participants in the study will: * Record daily sleep diaries via a mobile application for a total of 9 weeks * Receive daily intervention during a 4-week intervention phase as scheduled by the study * Complete weekly self-reported sleep questionnaires through the app * Undergo memory performance assessments at the beginning and end of the study

Restorative Effects of Sleep on Everyday Health and Wellbeing: A Treatment Study

The purpose of this study is to evaluate the mechanisms through which Cognitive Behavioral Therapy for Insomnia (CBT-I) leads to improvements in sleep and sleep-related daytime outcomes, specifically as it relates to cortisol and the hypothalamic-pituitary-adrenal (HPA) axis, the body's primary stress response system. The primary research aims are: 1) To determine whether changes in cortisol functioning are related to improvements in sleep consolidation (4-week CBT-I), sleep duration (10-week CBT-I) or both, AND 2) to examine whether these improvements are more pronounced among individuals with insomnia and short sleep duration (compared to insomnia with 'normal' sleep duration).This study will recruit individuals with chronic insomnia: half with reported short sleep duration (less than 6 hours of sleep on an average night) and half with reported non-short sleep duration (6 or more hours per night). Participants will complete an in-lab assessment on four different occasions. During the first visit, they will confirm eligibility, complete an online survey, complete an in-lab stress task (with saliva samples), and provide a hair sample to measure cortisol (a hormone). They will then be sent home with a home sleep test as a final eligibility check (to rule out sleep disorders other than insomnia), an actigraphy watch to measure their sleep, and collection tubes to provide saliva samples to measure cortisol. We will then track the participants' sleep using online daily diaries and actigraphy for four week. Following the 4-week baseline period, participants will come in for a second in-lab visit (same procedures as the first visit) and then be randomized to receive either four or ten weeks of Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is a empirically supported behavioral treatment for insomnia and the first-line treatment for chronic insomnia. Sleep patterns and insomnia symptoms will continue to be monitored via diaries during the intervention phase. The third visit will take place once the participant has completed the intervention and the fourth visit will occur three months following the third visit (3 months post-treatment). The 3rd and 4th visits will again replicate the same procedures conducted during the initial lab visit.

Insomnia Behavioral Intervention Study

This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia

This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.

Effect of MIT for CI With Anxiety

This randomized controlled trial aims to investigate the efficacy of Mindfulness Intervention Therapy (MIT) in treating Chronic Insomnia (CI) comorbid with anxiety symptoms.

Effects of Tai Chi on Chronic Insomnia Disorder Combined With Hyperarousal/Anxiety

This study focuses on individuals with chronic insomnia combined with excessive arousal/anxiety, with the main objective of investigating the effectiveness of Tai Chi in treating CI with excessive arousal/anxiety.

The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

Cancer-related fatigue (CRF) and insomnia are prevalent among cancer patients and have been linked to de-creases in quality of life and poorer overall survivorship. Currently, the mechanisms underlying CRF are not well understood, which has led to treatments that are only moderately effective. In addition, when compared to CBT-I in the general population, the treatment outcomes in CBT-I with cancer patients are subpar and, as such, this study will evaluate whether dose of CBT-I is effective in ameliorating CRF.

Effect of WBT for CI With Depression

This randomized controlled trial aims to explore the therapeutic effects of Well-Being Therapy (WBT) on patients with Chronic Insomnia accompanied by depressive symptoms.

Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients

This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.

Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\' sleep habits and maladaptive sleep behaviors.

Interest of Auriculotherapy in the Management of Chronic Insomnia

The aim of the study is to show that auriculotherapy is effective in the treatment of chronic insomnia.

Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients

Prospective observational crossover study of 150 consenting adult patients who are undergoing chronic pain management. For insomnia treatment, each patient ingests prescribed doses of Lemborexant or Zopiclone or Clonidine on alternate nights. Each patient uses a special validated sleep diary to collect data including pain score, sleep score, sleep duration, sleep medication type, and adverse effects. Each patient completes the diary for 3 continuous weeks. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.