Fatal Familial Insomnia

Researchers are studying individuals at risk for familial prion diseases such as Creutzfeldt Jakob Disease, Gerstmann-Sträussler-Scheinker syndrome, and Familial Fatal Insomnia. The aim is to identify biomarkers that can predict when symptoms might begin in people who carry genetic risks but do not yet show signs of disease. This research may also help guide future clinical trials focused on early treatment options. Participants in this observational study will attend annual visits at a clinic where they will undergo medical exams, blood tests, cognitive assessments, and questionnaires. They will also have spinal fluid collected, and optional MRI scans may be performed. Travel support and stipends are offered to assist with participation. Throughout the study, researchers will monitor biomarkers found in cerebrospinal fluid such as YKL40, Tau, Nfl, GFAP, prion protein, and other prion markers, alongside cognitive function over the course of one year. The study involves adults aged 18 to 85 who meet specific family history or genetic criteria and are medically able to complete testing, with ongoing safety and health monitoring during participation.

Researchers are evaluating the effects of dexmedetomidine and esketamine on sleep quality after heart surgery. The study aims to find out if these drugs can prevent postoperative sleep disturbances and which is more effective, comparing them to a saline placebo. This is a Phase 4 randomized trial focused on patients undergoing cardiac surgery with extracorporeal circulation. Participants are randomly assigned to receive an intraoperative continuous infusion of either dexmedetomidine at 0.3 ug/kg/h, esketamine at 0.3 mg/kg/h, or saline until the surgery ends. The study involves three groups: a dexmedetomidine group, an esketamine group, and a saline control group. The infusion happens during surgery only. During the first and third days after surgery, participants' sleep is assessed using a sleep rating scale. Researchers also monitor pain levels at 24 and 48 hours, use of pain medications, anxiety and depression at 1 and 3 days, postoperative complications at 48 hours, and delirium from day 1 to 7. The study runs from October 2024 to September 2025 and involves detailed monitoring of recovery quality and sleep outcomes.

Researchers are evaluating the effects of the probiotic Limosilactobacillus reuteri LM1063 on improving sleep health in healthy adults aged 19 to 65. This trial aims to understand if this specific probiotic can enhance sleep quality by acting on the microbiota-gut-brain axis. The study is a randomized, double-blind, placebo-controlled trial conducted at a single center, enrolling 80 participants divided equally into test and control groups. Participants in the test group will take one 500 mg capsule containing L. reuteri LM1063 (1.0 x 10^10 CFU/day) once daily, one hour before bedtime, for 8 weeks. The control group will receive a placebo capsule identical in appearance and dosing schedule. Both groups follow the same 8-week intake period under close monitoring. Throughout the study, participants will undergo assessments of sleep quality using polysomnography measures such as sleep efficiency, latency, total sleep time, and wake after sleep onset, along with the Pittsburgh Sleep Quality Index. Secondary evaluations include sleepiness and stress scales, blood markers like melatonin, GABA, and serotonin, and safety monitoring through adverse events, vital signs, and lab tests. The study tracks changes from baseline at the start and after 8 weeks of treatment.

Researchers are studying the effects of a drug called tasimelteon compared to a placebo in adults with Delayed Sleep-Wake Phase Disorder (DSWPD), a condition related to sleep timing problems. This is a phase 3, multicenter, double-blind, randomized trial designed to evaluate both the safety and effectiveness of tasimelteon in helping people with this disorder. Participants include men and women aged between 18 and 75 years with a confirmed diagnosis of DSWPD. Participants will receive either tasimelteon or a matching placebo in the form of an oral capsule taken once daily. The study uses a randomized assignment to one of these two groups and keeps participants and researchers unaware of which treatment is given to ensure unbiased results. The treatment period lasts 28 days during which sleep patterns and safety are carefully monitored. During the study, participants will keep sleep diaries to record their sleep onset and subjective sleep-wake patterns, while actigraphy devices will objectively track sleep times. Researchers will assess changes in sleep onset over 28 days as the primary outcome, along with other sleep parameters and safety based on reported adverse events. The trial includes close monitoring to ensure participant safety and adherence throughout the study period.

Researchers are evaluating the effects of a drug called tasimelteon compared to a placebo in adults diagnosed with Delayed Sleep-Wake Phase Disorder (DSWPD) who carry the CRY19411 gene variant. This phase 3 clinical trial aims to study the safety and effectiveness of a single oral dose of tasimelteon in improving sleep patterns in this specific group. Participants will receive either tasimelteon or a matching placebo in a double-blind, randomized, two-period crossover design. Each participant will receive both treatments in separate periods, allowing comparison of their effects within the same individual. Both tasimelteon and placebo are given as oral capsules. During the study, participants will undergo sleep assessments to measure how quickly they fall into persistent sleep, using polysomnography over two nights. The study involves careful monitoring of safety and efficacy during these treatment periods. Participation includes all visits and assessments related to dosing and sleep evaluation, with the entire process designed to understand how tasimelteon may influence sleep timing in DSWPD patients with the CRY19411 variant.

Researchers are investigating the link between being awake during the biological night (2:00-4:00 AM) and increased risks of negative mood, impaired decision-making, and suicidal thoughts. This study focuses on adults who have experienced suicidal ideation within the past six months, aiming to understand how biological timing and sleep pressure may contribute to suicide risk during late-night hours. Participants will undergo two different sleep conditions: one where they stay awake until 2:00 AM to create high sleep pressure, and another where they sleep and are awakened at 2:00 AM to create low sleep pressure. During both conditions, mood, suicidal thoughts, impulsivity, and decision-making will be assessed overnight in a laboratory setting. The study also uses behavioral and physiological measures, including melatonin levels, to examine circadian influences. During the study, participants will take part in assessments at home and in the lab, focusing on mood, hopelessness, suicidal ideation, impulsivity, and executive function, especially during the critical 2:00-4:00 AM window. Researchers will monitor feelings of hopelessness, negative mood, and decision-making abilities at specific visits. The study seeks to clarify how nocturnal wakefulness affects these factors and may help identify biological mechanisms underlying suicide risk. The total participation period includes assessments across different days and nights under controlled conditions.

Researchers are investigating sleep disorders in patients with hypothalamic and pituitary damage (HPD), conditions that affect vital functions including sleep-wake cycles. The study aims to identify how common sleep disorders are in these patients, understand the role of oxytocin in sleep quality, and explore the underlying mechanisms associated with sleep problems in HPD. This multidisciplinary research combines neuroendocrinology, psychology, neurophysiology, neuroimaging, nuclear medicine, and neuro-ophthalmology to improve knowledge and treatment options for affected individuals. This observational study compares patients with HPD, some with vasopressin deficiency, to healthy controls matched by age, sex, and body mass index. Participants undergo objective sleep assessments including actigraphy, polysomnography, and the Multiple Sleep Latency Test, as well as subjective sleep evaluations via questionnaires. Additional evaluations include brain imaging with MRI and PET-CT, ophthalmological exams, and hormone level testing from blood and urine samples. No drugs or interventions are administered during the study. Participants will be assessed over a period of up to three months, during which data on sleep quality, oxytocin and melatonin levels, brain structure and metabolism, and neuro-ophthalmological status are collected. Researchers will measure the prevalence of sleep disorders and examine brain and hormone abnormalities to understand their impact on health and quality of life in HPD patients. This comprehensive approach aims to identify new strategies for prevention and treatment of sleep disorders related to hypothalamic and pituitary damage.

Researchers are evaluating an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) to improve sleep and cognitive health in older adults with mild cognitive impairment and insomnia. This randomized controlled trial compares the CBT-I intervention to a patient education website, studying effects on sleep quality, daytime fatigue, quality of life, mood, and cognitive functions such as memory and attention. Participants are recruited online and must meet criteria for mild cognitive impairment and insomnia symptoms. Participants are randomly assigned to either the SHUTi OASIS online CBT-I program or a patient education website. The SHUTi program delivers tailored, interactive sleep therapy over 9 weeks, with new content released weekly and daily sleep diaries completed. The education group receives information about insomnia and CBT strategies all at once without tailoring. After the 9-week intervention, participants retain access to their assigned program for the study duration. Participants complete online cognitive tests, questionnaires, and sleep diaries at baseline, 9 weeks, then at 6, 12, 18, and 24 months. These assessments measure insomnia severity, sleep patterns, fatigue, quality of life, mood, and cognitive performance. The primary outcome is the Insomnia Severity Index, with additional measures including wake after sleep onset and sleep efficiency. The study lasts two years, with ongoing access to interventions and repeated assessments to track long-term effects.

This research aims to evaluate whether a structured combined exercise program can improve heart health, menopausal symptoms, sleep quality, and quality of life in postmenopausal women aged 45 to 65 years. It focuses on measuring heart rate variability as an indicator of nervous system control over the heart, alongside assessing menopausal symptoms and overall quality of life. The study compares women who participate in the exercise program with those who continue their usual daily activities. Participants in the exercise group will undergo a supervised 12-week structured combined exercise program, exercising twice a week for 45 minutes each session. Each session includes warm-up, balance, strengthening, coordination, flexibility, and cool-down exercises tailored to individual functional capacity under physiotherapist supervision. The control group will maintain their usual daily activities without any structured exercise intervention during the study. After the study, control participants will be informed about the exercise program and offered the chance to join. Throughout the study, researchers will assess heart rate variability, menopausal symptoms, sleep quality, quality of life, depressive symptoms, and hot flash frequency and severity at baseline, immediately after the 12-week program, and again 8 weeks later. Hot flashes will be tracked daily during the intervention and follow-up periods. The study involves careful monitoring and statistical analysis of these outcomes to understand the exercise program's effects on postmenopausal women's health.