Sleep Disorder

Researchers are investigating how balance and walking abilities relate to detailed movement measurements in people with Multiple Sclerosis MS. This observational study focuses on understanding the connection between clinical tests of function and objective biomechanical data. The goal is to identify which movement characteristics best reflect balance, gait, and physical performance challenges faced by individuals with MS. Participants will attend a single laboratory session where they undergo biomechanical analysis using the Vicon motion capture system. They will complete functional assessments of balance, gait, and physical performance, as well as questionnaires about fear of falling and fatigue. Spasticity in the lower limbs will also be assessed during this visit. During the session, participants will perform tests such as the mini-BESTest for balance, Functional Gait Assessment, Short Physical Performance Battery, and a 2-minute walk test. Questionnaires like the Fall Efficacy Scale and Fatigue Severity Scale will be completed. Researchers will analyze these collected data to explore how biomechanical and functional measures relate, aiming to improve assessment tools for MS rehabilitation.

Researchers are studying obstructive sleep apnea syndrome OSAS, a sleep disorder marked by loud snoring and repeated airway blockages during sleep that cause daytime tiredness. This observational study aims to create a prospective database to track changes in the upper airway volume and anatomy after maxillomandibular advancement MMA surgery, along with measuring the apnea-hypopnea index AHI and patients quality of life. The study collects detailed data on patient demographics, virtual 3D cone-beam CT CBCT surgical planning, orthognathic surgery details, sleep study results, and quality of life assessments as part of routine care.

Researchers are evaluating two methods for making occlusal splints night guards in adults diagnosed with bruxism, which includes teeth grinding and clenching. This randomized clinical trial aims to compare a 3D-printed photopolymer resin splint Voco V-Print with a conventional acrylic splint to determine if the newer 3D-printed option offers similar patient satisfaction and durability. The study focuses on adults aged 18 to 25 years with bruxism and temporomandibular disorders. Participants will be randomly assigned to receive either a 3D-printed splint or a conventional acrylic splint, both custom-made and adjusted as needed. They will be instructed to wear their assigned splint during sleep for three months, following standardized care and use instructions. The study includes a follow-up at 3 months to assess outcomes. During the study, patient satisfaction and oral health-related quality of life will be measured using a questionnaire based on the Oral Health Impact Profile OHIP. The splints will also be scanned with 3D technology at the start and after three months to measure wear by comparing volume loss. These assessments will help researchers understand patient experiences and the clinical durability of each splint type over the short-term period.

This trial investigates the use of 40 Hz flicker light stimulation to address insomnia in patients with Parkinsons disease PD, a condition marked by motor and non-motor symptoms including sleep disturbances. Current drug treatments for PD-related insomnia may not be sufficient and can cause side effects, so this study explores a non-drug method that may influence brain activity related to sleep regulation. Approximately 30 patients with PD and significant insomnia symptoms will participate in this randomized, single-blind, controlled study. Participants will be randomly assigned to one of two groups one receiving 40 Hz flicker light stimulation and the other receiving 100 Hz control light. Both groups will receive the light for 30 minutes each night at bedtime for seven consecutive nights, alongside their stable Parkinsons medication. The flicker light is delivered using a specialized device with parameters adjusted for safety and comfort. The study focuses specifically on this PD insomnia group within a larger parent protocol. Throughout the trial, participants will complete sleep assessments including the Parkinsons Disease Sleep Scale-2 PDSS-2, sleep quality questionnaires, and sleep diaries. Objective sleep measures such as total sleep time and awakenings will be collected using polysomnography when possible. Other non-motor symptoms will also be evaluated. Safety will be monitored through adverse event tracking, vital signs, and checking for any visual discomfort. The primary outcome is the change in PDSS-2 score from baseline to Day 7, with additional follow-up assessments conducted at Day 28.

Idiopathic hypersomnia IH is a rare, chronic disorder marked by excessive daytime sleepiness, long nighttime sleep, and difficulty waking up. It often begins in young adulthood and causes serious social, professional, and economic challenges, leading to accidents and reduced quality of life. There are currently no approved treatments for IH symptoms. This study aims to test a safe treatment combining evening melatonin and morning bright light therapy, which has been effective in related sleep disorders and may improve alertness and mood in IH patients. Participants will receive either an active therapy of one melatonin tablet each evening plus morning bright light therapy, or a placebo consisting of a placebo tablet and placebo light therapy, both over a period of 6 weeks. This randomized, triple-blind trial compares these two groups to evaluate the effects of this combined chronobiological treatment. The study is conducted by the University Hospital in Strasbourg, France. During the study, participants will be monitored and assessed for changes in their IH symptoms using the Idiopathic Hypersomnia Severity Scale at days 14 and 45. The study includes careful screening, adherence to treatment schedules, and safety checks. Participants will be followed throughout the 10 weeks of the study to evaluate treatment impact and tolerability, with all procedures designed to understand if this therapy improves daytime alertness and quality of life.

Researchers are evaluating how Continuous Positive Airway Pressure CPAP treatment affects blood pressure in adults aged 18 to 70 who have obstructive sleep apnea OSA and high or uncontrolled blood pressure. The study aims to find out which patients benefit the most in blood pressure reduction from CPAP and whether adding a sleep aid medication can improve CPAP effectiveness for those who experience insomnia or frequent awakenings at night. This observational study is sponsored by Beijing Anzhen Hospital and focuses on blood pressure control and sleep quality in OSA patients. Participants will use an auto-titrating CPAP device for at least 4 hours each night and at least 21 nights per month over about 3 months, with fitted masks and support to encourage use. Those with difficulty sleeping may also choose to take a short course of sleep aid medication trazodone or zopiclone for 4 weeks. The study forms natural sub-groups based on these interventions CPAP only, CPAP plus trazodone, CPAP plus zopiclone, or drug only for those who decline CPAP. During the study, participants will undergo full-night sleep monitoring and 24-hour blood pressure monitoring to tailor CPAP pressure. Researchers will use questionnaires, actigraphy wristwatches, and additional sleep studies to observe changes in sleep and blood pressure. Blood and urine samples will be collected for safety checks. Participants are free to withdraw anytime without penalty, and study-related care including devices, medications, and tests are provided at no cost. The primary outcome measured is blood pressure after 3 months of CPAP treatment.

Researchers are investigating how obstructive sleep apnea OSA affects fat tissue and its role in increasing the risk of cardiovascular disease. This study focuses on examining the cellular and molecular changes in fat tissue of adults with OSA compared to healthy individuals. It aims to better understand how damaged fat tissue may contribute to insulin resistance, inflammation, and higher blood pressure in people with OSA. The study involves comparing fat tissue samples from two groups those with obstructive sleep apnea defined by an Apnea Hypopnea Index of 5 or higher and those without it AHI less than 5. Researchers will analyze markers of cellular damage in the fat tissue, such as p16 and gamma H2AX, to identify differences. The study is observational and does not involve treatment, focusing on tissue analysis and cardiovascular health markers. Participants will undergo assessments including fat tissue sampling to measure cellular damage markers, body composition analysis, blood pressure monitoring over 24 hours, evaluation of vascular function, and insulin sensitivity tests. The primary outcome is the prevalence of specific damaged cells in fat tissue. The total study duration and visits are arranged to gather this data, with no investigational treatments administered. The study is sponsored by the Mayo Clinic and includes adults aged 18 to 60 years.

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 4042 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.

This trial evaluates a behavioral sleep intervention called Care2Sleep for persons with Alzheimers disease and their caregivers. The study aims to improve sleep, health, and quality of life for both members of the dyad and to assess inflammation markers in caregivers. Participants will be randomly assigned to one of three groups in-person Care2Sleep, telehealth Care2Sleep, or an in-person education control group. The trial follows a randomized controlled design over 5 years and uses Stage II of the NIH model for behavioral intervention development. The study involves five sessions of the assigned program, whether in-person or via telehealth for Care2Sleep groups, or education-only sessions without individualized recommendations for the control group. Interventions include sleep hygiene, stimulus control, sleep compression therapy, pleasurable activities, daily walking, and light exposure for Care2Sleep participants. Sessions begin after baseline assessments and randomization. Post-treatment assessments are conducted immediately after the last session and again at 6 months. Participants will undergo baseline and follow-up evaluations including sleep efficiency measured by actigraphy and Pittsburgh Sleep Quality Index scores. Additional assessments involve cognitive and behavioral measures, quality of life scales, caregiver burden, depression scales, global health, and inflammatory markers. These evaluations occur immediately after treatment and at 6 months. The total participation duration spans from baseline through the 6-month follow-up, with careful monitoring of sleep and health outcomes for both patients and caregivers.

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.