Insomnia

Researchers are studying the potential neuroprotective effects of a dual orexin receptor antagonist (DORA) called Lemborexant in adults with insomnia. The main goal is to see if this treatment reduces blood biomarkers linked to neurodegeneration, including phosphorylated TAU181, TAU217, amyloid beta 40:42 ratio, Neurofilament Light Chain (NFL), and Glial Fibrillary Acidic Protein (GFAP) compared to a placebo. This is a randomized, placebo-controlled crossover study focusing on adults aged 40 to 65 with insomnia disorder. Participants will take 10mg of Lemborexant orally each night for two weeks and a matching placebo nightly for another two weeks, with a 2 to 4 week washout period between treatments. After each treatment phase, participants will visit the research facility for an overnight stay lasting about 18 hours. During this visit, they will undergo various assessments including high-density EEG, functional near-infrared spectroscopy, questionnaires, pupillometry, and blood sample collections. Throughout the study, participants will attend three visits: an initial screening and two overnight visits after each treatment period. Blood samples will be collected hourly for four hours following awakening during these visits to measure key biomarkers. Researchers will monitor sleep and brain activity, collect questionnaire data, and evaluate safety. The total involvement includes treatment periods, washout, and overnight assessments, ensuring thorough evaluation of treatment impact on neurodegeneration markers.

Researchers are evaluating the effectiveness of the Care2Sleep behavioral sleep intervention program for people with Alzheimer's disease or related dementias and their caregivers. This randomized controlled trial lasts 5 years and focuses on improving sleep quality, health status, quality of life for both patients and caregivers, and inflammation levels in caregivers. The study uses Stage II of the NIH behavioral intervention development model to assess these effects. Participants will be assigned randomly to one of three groups: in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. Both Care2Sleep programs involve manual-based sleep hygiene recommendations, behavioral sleep intervention, and sleep compression therapy, delivered in five sessions. The education control group receives general information on sleep, aging, and dementia without personalized recommendations. The intervention and control programs start after baseline assessments and randomization. Participants will complete assessments immediately after the last session and again at 6 months to measure sleep efficiency and Pittsburgh Sleep Quality Index scores. Other evaluations include memory and behavior problems, quality of life, caregiver burden, depression, global health, and inflammatory markers. Safety and adherence are monitored, and the total participation duration spans from baseline through a 6-month follow-up.

Researchers are evaluating two types of behavioral treatments for insomnia among socioeconomically disadvantaged adults in primary care. The study aims to test whether tele-Brief Behavioral Treatment for Insomnia (BBTI) is not less effective than tele-Cognitive-Behavioral Therapy for Insomnia (CBTI). The trial focuses on adults diagnosed with insomnia, particularly those facing socioeconomic challenges, to find accessible treatment options. The study compares two telehealth interventions: BBTI, which involves up to five weekly phone sessions delivered by various practitioners without formal sleep training, and CBTI, a more comprehensive therapy conducted by trained mental health clinicians over 6 to 12 weeks. Participants are randomly assigned to one of these two groups to receive the respective treatment remotely. Participants will be monitored over several months, with primary outcomes measured by the Insomnia Severity Index at 3 months. Secondary outcomes include insomnia severity at 6 and 12 months, quality of life assessments, anxiety and depression measures, sleep impairment and disturbance scales, sleep diary reports, and hypnotic medication use. The study tracks these outcomes through patient-reported questionnaires and sleep diaries to evaluate treatment effects and overall health impact.

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

Researchers are evaluating a combined sleep promotion and cognitive training intervention to help improve cognitive function in older survivors of intensive care units (ICU). This study focuses on adults aged 60 and older who are at high risk for delirium and cognitive decline similar to mild Alzheimer's disease after ICU discharge. The study aims to assess whether these interventions can reduce the risk of developing Alzheimer's disease and related dementias by addressing sleep deficiency, inactivity, and circadian rhythm disturbances common in ICU survivors. Participants will be randomly assigned to one of four groups: a combination of nighttime sleep promotion using earplugs and eye masks plus daily 30-minute computerized cognitive training sessions; cognitive training alone; sleep promotion alone; or an active control group receiving educational modules on brain health. The interventions last up to seven days following ICU discharge, with cognitive training sessions scheduled based on individual circadian rhythms measured by a wearable sensor. During the study, participants will be monitored using body temperature sensors to optimize the timing of cognitive training. Researchers will assess cognitive function, including executive function and working memory, at several time points: within seven days after hospital discharge, and at one, six, and twelve months follow-up. The study also examines how sleep and activity may influence cognitive outcomes, with safety and ongoing care monitored throughout the study period, which concludes in May 2027.

Researchers are evaluating the effectiveness and safety of lemborexant, a new dual orexin receptor antagonist, in treating adults with mental disorders complicated by insomnia. This observational study focuses on patients aged 18 and above who meet the DSM-5 criteria for mental disorders and have an Insomnia Severity Index score of 11 or higher. The study aims to provide real-world evidence for optimizing treatment plans for insomnia alongside psychiatric conditions. Participants will receive lemborexant tablets taken orally before bedtime, starting at 5 mg per day, which may be increased to 10 mg based on clinical response and tolerance. The treatment period lasts 8 weeks, including a baseline assessment week and 8 weeks of active treatment. Patients who are using benzodiazepine receptor agonists at the start are recommended to gradually reduce and stop these within the first 4 weeks. The study is single-arm and prospective, with all participants receiving lemborexant. During the study, participants will complete various assessments including the Insomnia Severity Index, Sleep Satisfaction VAS, and Epworth Sleepiness Scale at baseline, week 4, and week 8. Researchers will monitor changes in insomnia symptoms, treatment retention, benzodiazepine discontinuation rates, dose adjustments, and adverse events. The total duration of participation is approximately 8 weeks, with follow-up to observe symptom improvement and safety outcomes.

Researchers are evaluating a new inhaled form of melatonin compared to oral melatonin tablets in adults aged 55 and older who have insomnia. The trial aims to understand if inhaled melatonin affects sleep patterns, such as how quickly participants fall asleep, differently than oral tablets. This is an early phase 1, randomized open-label crossover study conducted to explore these potential differences in sleep quality and neuroinflammation markers. Participants will receive two treatments in different periods: inhaled melatonin delivered by a pressurized inhaler at a dose of 100 micrograms (two puffs) nightly for two weeks, and oral melatonin tablets at a dose of 4 mg (two tablets) nightly for two weeks. After each treatment period, there is a one-week washout before crossing over to the other treatment. The study includes overnight stays in a sleep laboratory for sleep monitoring and blood collection visits to assess biomarkers. During the study, participants will visit the research center five times: for screening, overnight sleep studies at the start of each treatment period, and blood collection after each treatment. They will complete daily sleep diaries to record their sleep quality during the two-week treatment periods. Researchers will measure sleep onset latency primarily and also assess sleep time, wakefulness after sleep onset, insomnia severity, and subjective sleep quality. Safety and adherence will be monitored throughout the study, which is expected to end in May 2026.

Researchers are evaluating a new inhaled form of melatonin compared to oral melatonin tablets in adults with insomnia. The study aims to understand if inhaled melatonin reaches peak blood concentration and is cleared from the body differently than oral tablets. This early phase 1 randomised open-label crossover trial focuses on adults aged 55 and older with insomnia disorder, exploring how the delivery method affects melatonin's absorption and elimination. Participants will receive two treatments in random order: inhaled melatonin (100 bcg via pressurized metered dose inhaler) and oral melatonin tablets (4 mg). Each treatment is taken once during a daytime visit, followed by blood sampling over an 8-hour period to measure melatonin levels at multiple time points. There is a one-week washout period between treatments. The study involves three visits total, including screening and two treatment visits. During each treatment visit, participants stay in the lab for about 8 hours, providing blood samples every 15 minutes during the first hour and then hourly. They will also rate their sleepiness using the Karolinska Sleepiness Scale at each blood collection. Researchers will measure the time to maximum melatonin concentration, melatonin area under the curve, peak blood concentration, melatonin half-life, and daytime sleepiness. This comprehensive monitoring helps compare the effects of inhaled versus oral melatonin on sleepiness and blood melatonin levels.

Researchers are studying the use of a personalized mobile application called SHIFT to improve sleep in night shift workers with Shift Work Sleep Disorder. The study aims to build evidence for fair access and effective use of this precision sleep medicine tool, which uses body-clock data collected from an Apple Watch to provide tailored light exposure schedules. The trial is randomized and double-blind, comparing the SHIFT app to a waitlist control group over a period of up to eight months. Participants in the SHIFT app group receive access codes to download the app and attend an orientation session. They then follow a four-week period of guided app use where they start their day with the app and plan their activities based on its recommendations, using the app about four times per week. This is followed by self-directed use, with a booster session at four months that includes two additional weeks of guided use before continuing self-directed use until the study ends. The waitlist control group completes questionnaires during the first eight months and may choose to use the app afterward if still working night shifts. During the study, participants complete surveys and app usage is monitored to assess engagement, experience, and accuracy of the app on different platforms. The main outcomes include evaluating the effect of SHIFT on participant-centered results and comparing app versions from enrollment through eight months. Additional assessments explore factors that help or hinder app use. The study involves regular evaluations over the first eight months, with follow-up and safety monitoring continuing until the study concludes in mid-2027.

The trial investigates the WatchPAT (WP) device's ability to detect sleep disorders compared to the gold standard polysomnography (PSG) in patients suspected of sleep disorders. Participants include individuals referred for sleep studies or those with comorbidities related to central sleep apnea. The study is prospective and blinded, aiming to gather data on the WP device's performance during clinical sleep evaluations. Participants will spend one night in a clinical sleep laboratory where they will simultaneously wear the WP device with a finger probe and chest sensor while undergoing a full-night PSG recording with standard channels. The PSG data will be recorded and manually scored without access to WP data to maintain blinding, while the WP device data will be analyzed automatically. This design allows comparison between the WP device and PSG results. During the study night, demographic and medical information will be collected from participants or their medical charts. Researchers will assess the Apnea-Hypopnea Index (AHI) and sleep stages from one night of sleep as primary outcomes, with the Respiratory Disturbance Index (RDI) as a secondary outcome. The study involves a single overnight visit with no long-term follow-up, focusing on accurately measuring sleep disorder indicators through both methods.