Sleep Disorder

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

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.

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 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 conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis: narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatment's safety and to understand its effects over time, with participant involvement lasting through the entire study period.