Narcolepsy

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 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 treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

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. Childrens 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 childs 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 interventions impact and app feasibility over the 12-week period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

The trial investigates the WatchPAT WP devices 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 devices 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 drugs 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 1 NT1 is a sleep disorder characterized by excessive daytime sleepiness and sudden muscle weakness while conscious, known as cataplexy. This trial evaluates the safety and tolerability of TAK-360 in adults with NT1. Participants must stop their current NT1 medications before starting the study treatment. They may be randomly assigned to receive either TAK-360 or a placebo, which looks identical but contains no active medicine. The trial is sponsored by Takeda and uses a randomized, double-blind design. Participants will take TAK-360 or matching placebo tablets orally. The study includes multiple parts where participants receive either TAK-360 or placebo in a parallel design. After the treatment period lasting up to about 28 weeks, participants will be monitored for an additional two weeks. Following study treatment, participants can resume their usual NT1 medications. Throughout the trial, participants will visit the clinic multiple times for evaluations. Researchers will assess treatment-emergent adverse events, sleep latency using the Maintenance of Wakefulness Test, sleepiness levels with the Epworth Sleepiness Scale, and weekly cataplexy rates. Safety and tolerability will be closely monitored, and participants usual care will continue after the study ends.