Narcolepsy

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 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.

Researchers are studying the safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This open-label, long-term extension study builds on previous ALKS 2680 parent studies and aims to understand how well the treatment works over time and how safe it is for participants living with these sleep disorders. Participants will take oral tablets of ALKS 2680 once daily, with doses ranging from 4 mg to 18 mg. The study is non-randomized and includes groups of people with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. Those joining the study may need to stop other narcolepsy medications before starting ALKS 2680 and continue taking ALKS 2680 throughout the trial. During the study, participants will be monitored for treatment side effects and changes in sleepiness using tests like the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. Researchers will track adverse events for up to 100 weeks and evaluate changes in sleep latency and sleepiness over several months. The study supports close safety monitoring and long-term follow-up from the start in early 2025 until mid-2028.

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.

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.

Researchers are evaluating the "SIESTA" intervention, a culturally tailored sleep hygiene program designed to improve sleep health in urban Latino middle school children aged 11 to 13 years who typically sleep 9 hours or less per night. The study aims to see if SIESTA participants have better sleep outcomes, improved sleep hygiene behaviors, and less sleep-related impairment compared to a control group receiving general health education. This large-scale randomized trial will enroll 300 children from Providence, Rhode Island and San Juan, Puerto Rico. The SIESTA intervention involves four one-hour group sessions conducted remotely by a trained facilitator, plus two 90-minute individualized sessions with the child and caregiver delivered at home. The program focuses on key sleep hygiene principles tailored to urban Latino children, including sleep duration, sleep environment, and strategies to improve sleep quality. The control group participates in four group sessions on basic sleep hygiene and general child health topics, along with two individualized sessions, but without tailored behavioral strategies. Participants will complete surveys at baseline, end of treatment, and at 4, 8, and 12 months post-intervention. They will wear electronic sleep watches to objectively track sleep duration and quality throughout the study. Researchers will assess primary outcomes such as sleep duration and efficiency and secondary outcomes including sleep disturbances and sleep-related impairments. The study also involves a process evaluation to understand program reach, adoption, and implementation in urban school settings. Total participation lasts about 14 months.

Researchers are evaluating the safety, tolerability, and how the body processes a drug called ORX142 in healthy adults aged 18 to 80 years. This Phase 1 clinical trial includes several parts to study single and multiple doses, the effects of food on the drug, and tests in both younger and older adults, as well as in people who have been acutely sleep-deprived. The study aims to understand the drug's effects on excessive daytime sleepiness. Participants will receive ORX142 or placebo tablets in different parts of the study. Parts A, B, and C focus on single and multiple ascending doses in healthy adults, with Part B examining the food effect on the drug. Part D studies single doses in healthy older adults, while Part E tests the drug in acutely sleep-deprived healthy adults. The study uses a randomized, double-blind, placebo-controlled design. During the trial, participants will be closely monitored for side effects and treatment-emergent adverse events from enrollment until 13 days after discharge. Blood samples will be taken before and after dosing to measure drug levels and how the body processes it over time. Sleepiness will be assessed using tests like the Maintenance of Wakefulness Test and the Karolinska Sleepiness Scale in Part E. Overall participation duration varies depending on the part of the study involved.

Researchers are evaluating the safety, tolerability, and effects of ORX750 in adults with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH). These rare conditions cause excessive daytime sleepiness and affect daily activities such as school, work, and driving. The study aims to understand how ORX750, which mimics the brain protein orexin that helps maintain wakefulness, impacts sleepiness and other symptoms in these conditions. Participants will receive either ORX750 capsules or matching placebo capsules in a randomized, double-blind setup. The study assesses multiple groups: those with NT1, NT2, and IH. The treatment and monitoring will occur over a period of up to 35 days, including evaluation of plasma drug levels and sleepiness measures. During the study, participants will undergo safety assessments including monitoring for adverse events, laboratory tests, vital signs, ECGs, and suicidal ideation screening up to day 35. Researchers will also measure sleepiness using the Maintenance of Wakefulness Test and the Epworth Sleepiness Scale. The total study duration for each participant is about five weeks, with careful observation of how the body processes ORX750 and its effects on daytime alertness.

Narcolepsy Type 2 (NT2) is a lifelong condition that causes excessive daytime sleepiness, sudden sleep episodes, and difficulty staying awake, affecting daily activities like driving and working. This trial is studying TAK-360, a medicine that acts like orexin, a brain chemical that helps keep people awake. The study aims to evaluate the safety, tolerability, and proper dosage of TAK-360 in adults with NT2. Participants will be randomly assigned to receive either TAK-360 or a placebo tablet orally for 4 weeks. The placebo looks like TAK-360 but contains no active medicine. This randomized, double-blinded trial compares TAK-360 with placebo to understand its effects on wakefulness and safety in adults with NT2. During the study, researchers will monitor side effects and measure sleepiness using tests like the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test at the start and after 4 weeks. Participants will be observed for up to 15 weeks to track any treatment-related adverse events. This trial helps determine how TAK-360 is tolerated and its impact on staying awake for adults with NT2.

Researchers are evaluating the safety and tolerability of TAK-861 in people with narcolepsy type 1 (NT1). This study focuses on participants who have already been exposed to TAK-861 doses in previous clinical trials. The goal is to monitor how TAK-861 affects symptoms such as excessive daytime sleepiness and cataplexy episodes over a long period. All participants in this trial will receive TAK-861 tablets. Those who previously received a placebo will be randomly assigned to one of the TAK-861 dose groups. The study is a long-term extension conducted worldwide and is expected to last approximately five years or until the product is approved or the study is stopped. Participants may switch doses as needed and will attend multiple clinic visits, some of which can be done at home. Throughout the trial, participants will be regularly assessed for safety by tracking any treatment-emergent adverse events. Researchers will also measure changes in sleep latency, sleepiness scores, and cataplexy rates compared to baseline data from earlier trials. Follow-up assessments will take place four weeks after the final dose to monitor ongoing effects and ensure participant safety.