Clinical Research Directory

Restorative Early Sleep Treatment After the Emergency Department

The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. The main aims are to: 1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance 3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms The investigators will compare CBT-I and CBT-I\&N to sleep education control. Participants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.

Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.

Targeting Sleep and Slow-Wave Activity to Enhance Cognition in MCI

Study Description As most clinical trials in Alzheimer's disease (AD) have been unsuccessful to date, it has become increasingly crucial to focus on treating earlier stages of the disease. Compelling evidence indicates that sleep disruption is associated with accumulation of Alzheimer's biomarkers, including amyloid-beta (Aβ) and tau pathology. Slow-wave activity (SWA) during sleep is particularly important for the clearance of Aβ and sleep-dependent memory consolidation, and sleep disturbance could reduce the amount of time spent in slow-wave sleep. Together, these findings suggest that treating sleep disruption in older adults may help reduce the level of adverse brain aging. The goal of this study is to better understand the effect of sleep interventions on improving sleep and building cognitive resilience in older adults with amnestic mild cognitive impairment (aMCI), and to assess the feasibility of relevant study protocols. Fifty older adults (ages 60-85) with aMCI and sleep disturbance (Insomnia Severity Index score of 8 or greater) will be randomized 1:1 to one of two treatment arms: Cognitive Behavioral Therapy for Insomnia only (CBT-I + Sham), or CBT-I combined with acoustic slow-wave activity enhancement (CBT-I + SWAE). CBT-I is a psychotherapy intervention designed to address maladaptive cognitive and behavioral patterns associated with sleep and bedtime. SWAE is administered through non-invasive earbuds (Smartbuds, NextSense Inc.) that detect and amplify endogenous slow-wave activity using acoustic pulses during sleep. Each participant will complete 3 visits over approximately 6 months: a baseline visit, a post-treatment visit (approximately 12 weeks after baseline), and a 6-month follow-up visit. Group differences will be compared on changes in cognitive performance and plasma biomarkers of AD (phosphorylated tau \[pTau-217\]) across these time points. The study will also explore potential mechanisms behind the relationship between sleep and cognition/biomarkers by investigating a range of objectively measured sleep metrics (e.g., sleep architecture, sleep duration, arousals) along with depressive symptoms. Hypotheses: CBT-I will be associated with more favorable outcomes (i.e., less decline or greater improvement) in frontal network functioning (sustained attention/target detection, executive functions), while SWAE will be associated with better outcomes in measures of episodic memory (word-list learning and story recall). Improvements in total sleep time and insomnia symptoms at 8 weeks are hypothesized to mediate the relationship between CBT-I and performance on attention and executive functions over 6 months, while improvements in slow-wave non-rapid eye movement (NREM) sleep at 12 weeks are hypothesized to mediate the relationship between SWAE and episodic memory measures. Additionally, CBT-I is hypothesized to be associated with increased scores on the Visuospatial Abilities, Planning, Organization, and Divided Attention subscales of the Everyday Cognition (ECog) questionnaire after 6 months, while SWAE is hypothesized to be associated with a significant increase in the Everyday Memory subscale. Objectives: Aim 1: To determine if CBT-I and SWAE have different neuropsychological outcomes in aMCI. Aim 2: To examine the impact of sleep treatments on cognitively mediated everyday functioning. Exploratory Aim: To assess whether CBT-I and/or SWAE are associated with changes in plasma pTau and whether pTau moderates the association between sleep and cognition. Results from this study will determine whether sleep interventions can build brain and cognitive resilience in the context of aging, and will inform the design of a future, larger-scale R01 study rigorously examining the association between targeted sleep modifications and markers of AD pathophysiology as a potentially modifiable risk factor for dementia.

Perinatal Research on Improving Sleep and Mental Health

The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.

Efficacy Assessment of Probiotics in Improving Sleep Indices

To determine whether PS150 (1) reduces insomnia symptoms, (2) improves sleep quality, (3) adjusts autonomic nervous system functioning, (4) reduces the severity of anxiety and depressive symptoms, and (5) adjusts microbiome and endocrine functions.

Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®

This study will investigate pregnancy, neonatal, and infant outcomes in women exposed to QUVIVIQ during pregnancy compared to women unexposed to QUVIVIQ during pregnancy.

AI-Driven Digital Therapeutic for Insomnia: Development and Clinical Validation

Insomnia is a prevalent global health problem, with approximately one in five Taiwanese adults chronically affected. Prolonged use of sedative-hypnotic medications carries risks of adverse effects, dependence, and unnecessary healthcare utilization. Although cognitive behavioral therapy for insomnia (CBT-I) is internationally recommended as first-line treatment, workforce shortages and suboptimal patient adherence limit its reach. This project will develop an artificial intelligence-driven mobile application for insomnia that implements the CBT-I components of stimulus control and sleep restriction. Using retrieval-augmented generation and large language models, \*\*the investigators will build\*\* a localized sleep knowledge base to deliver personalized, interactive sleep guidance. A pilot randomized controlled trial will assess the intervention's effectiveness in reducing insomnia severity and sedative-hypnotic use. \*\*The investigators will subsequently pursue\*\* a large-scale clinical trial and iterative model optimization, aiming to deliver the first clinically validated AI-enabled prescription digital therapeutic for insomnia and to advance smart healthcare in sleep care.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder

The Department of Acupuncture-Moxibustion, the First Affiliated Hospital of Zhejiang Chinese Medical University is conducting a clinical research project entitled "Randomized Controlled Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation (transcutaneous auricular vagus nerve stimulation，taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder". This study aims to explore the short-term clinical efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS), based on the theory of "Heart-Kidney Interplay", in improving insomnia among patients with methamphetamine use disorder in the withdrawal-rehabilitation period on the basis of routine drug-addiction rehabilitation. The primary efficacy outcome is the change in total score of the Insomnia Severity Index (Insomnia Severity Index,ISI) from baseline to Week 4. This project will commence in September 2026, and a total of 96 participants with methamphetamine use disorder in the withdrawal-rehabilitation period will be recruited.

Innovating CBT-I for Cancer Survivors: An Optimization Trial

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Trial on the Effect of Optically Modified Fiber Mattress Covers on Sleep Disturbances in Patients With Chronic Back Pain

Sleep quantity and quality can be influenced by the type of mattress used. This study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.

Music Therapy in Post-Stroke Patients: A Clinical Trial

The goal of this clinical trial is to learn if music therapy works to optimizate sleep quality in patients who have suffered a stroke. The main questions it aims to answer are: * What is the effect of music therapy on subjective sleep quality in stroke patients? * What is the effect of music therapy on the subjective perception of insomnia in stroke patients? * What is the effect of music therapy on levels of hospital anxiety and depression in stroke patients? * What is the level of satisfaction with the music therapy intervention? Researchers will compare an intervention group consisting of patients who will undergo music therapy with a control group of participants receiving standard care without music therapy sessions. Participants will: * Complete some questionaries about sleep quality (Pittsburgh Sleep Quality Index), inmsonia (Insomnia Severity Index), anxiety and depression associated with hospitalization (Hospital Anxiety and Depression Scale) before and after de intervention. * Intervention group receive daily 60-minute music therapy sessions at night during their hospitalization, whenever possible. * Intervention gruop have to report their perceived level of satisfaction with the music therapy.

Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer

The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time. A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties. The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.

Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors

This pilot study will recruit Black/African American prostate cancer survivors into a clinical trial and will randomize each person to 1 of 2 possible treatments - an internet-based treatment for insomnia called Sleep Healthy Using the Internet (SHUTi) or an educational website. SHUTi provides the treatment - cognitive behavioral therapy for insomnia - across 6 lessons, while the educational website is like an online patient brochure. The study will examine the feasibility of SHUTi to improve sleep and well-being among Black prostate cancer survivors. It will also examine whether SHUTi is acceptable to these survivors and will compare the effect of SHUTi versus the educational website on insomnia and non-insomnia patient-reported outcomes.

Telenursing-Based Sleep Coaching for Adults Living With HIV With Insomnia Symptoms

Insomnia is common among people living with HIV and is linked to fatigue and lower quality of life. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended first-line treatment, but access is limited in Indonesia. This study develops a nurse-led sleep coaching programme based on CBT-I principles and delivered online (telenursing), and tests whether the programme and the study procedures are feasible. Fifty adults living with HIV who have insomnia symptoms will complete two baseline assessments four weeks apart, four weekly online coaching sessions and a follow-up assessment four weeks after the last session. The study measures recruitment, retention, attendance, adherence, data completeness, fidelity, usability and safety, and describes changes in sleep, fatigue, pain, anxiety and depression.

Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)

Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.

Brain and Heart Rhythm Responses to a Breathing-Linked Sound Application (BELL-001) in Adults With Insomnia Symptoms

The purpose of this study was to describe how brain activity and heart rhythm respond to BELL-001, a smartphone application that plays sounds linked to the user's own breathing, compared with a sham application that looks the same but does not link its sounds to breathing. Adults with self-reported insomnia symptoms were randomly assigned to BELL-001 or to the sham application. During one laboratory visit, brain activity was recorded with electroencephalography (EEG), heart activity with electrocardiography (ECG), and breathing with a chest belt while participants rested with their eyes closed, then used the assigned application actively for 10 minutes, and then listened passively for 50 minutes. After the visit, all participants, regardless of laboratory group, used the BELL-001 application at home for 7 nights in an open-label period while wearing a smartwatch.

Enhancing Operational Readiness With Digital Self-Managed Cognitive Behavioral Therapy for Insomnia (CBTI)

The goal of this pilot clinical trial is to evaluate the effectiveness and delivery method of a CBTI self-managed digital mobile application in service members. The main questions it aims to answer are: RQ1. Will the delivery of CBTI via a self-managed mobile application over five weeks improve sleep outcomes for service members? RQ2. Will the delivery of CBTI via a self-managed mobile application over five weeks improve secondary outcomes (sleep-related impairment, depression, PTSD symptoms, and quality of life) for service members?

Deep Sleep in Older Adults

This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \[IoT\]+Artificial Intelligence \[AI\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.

Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)

This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants. Primary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), and CPAP adherence. The study aims to establish an evidence-based digital health intervention for improving sleep outcomes in COMISA patients.

Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.

This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.

Adenosine A2a Receptor-Mediated Neuroinflammation in Remote Ischemic Conditioning for Post-Stroke Sleep Disorders

This is a single-center, prospective, randomized, double-blind, sham-controlled study. It will test whether remote ischemic conditioning (RIC), a non-invasive arm-cuff treatment, can improve insomnia after ischemic stroke and whether adenosine A2A receptors and neuroinflammation are involved. About 136 patients will be enrolled. Eligible participants are 18-80 years old, right-handed, have had a first imaging-confirmed ischemic stroke 3-6 months earlier, have an mRS score ≤3, and report insomnia with a PSQI score \>5. Patients with other sleep disorders, severe medical conditions, or recent use of sleep-affecting medications will be excluded. Participants will be randomly assigned to RIC (cuff pressure 200 mmHg) or sham control (60 mmHg). Both groups will receive treatment twice daily for 90 days. Each session lasts 45 minutes and includes 5 cycles of 5-minute ischemia and 5-minute reperfusion. The primary outcome is the PSQI score at 90 days. Secondary outcomes include PSQI response (≥5-point decrease), insomnia remission (ISI \<8), polysomnographic sleep measures, fatigue, daytime sleepiness, mood, quality of life, blood inflammatory markers, and A2A receptor expression on monocytes. Follow-up will occur at 1, 2, 3, 6, and 12 months. This study may determine whether RIC is a safe, non-drug option for post-stroke insomnia and help clarify its anti-neuroinflammatory mechanism.

Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.

Project Women's Insomnia Sleep Health Equity Study (WISHES)

The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.

Suvorexant for Treatment of AUD and PTSD

This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.