Tag: CLINICAL TRIALS

Clinical Trial of Early Morning Shift Workers Shows Promise of New Drug for Reducing Excessive Sleepiness
Clinical Insights Sleep Pharmaceuticals

Clinical Trial of Early Morning Shift Workers Shows Promise of New Drug for Reducing Excessive Sleepiness

Many more people work very early morning shifts than overnight ones, and a large proportion struggle with excessive sleepiness from shift work disorder, leading to problems with focus, performance and safety. A new clinical trial by investigators from Mass General Brigham found that the wake-promoting drug solriamfetol (Sunosi) helped early […]

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG
Clinical Insights Industry News

Sunrise Announces Landmark SUNSAS Trial Results, an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG

Sunrise Group announced results from the SUNSAS clinical study, now published in The Lancet Regional Health – Europe, a leading international medical journal. Supported by the French Ministry of Health through the Forfait Innovation program, this study is the largest randomized controlled trial to date evaluating an at-home diagnostic pathway for obstructive […]

Nexalin Announces Pivotal HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market
Industry News Insomnia Research/Studies

Nexalin’s HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Insomnia Market

Nexalin Technology, Inc. announced continued advancement toward its planned pivotal clinical trial evaluating HALO™ Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin’s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical […]

Why Night Guards Aren’t Enough: Addressing the Neurological Roots of Sleep Bruxism with Biofeedback
Sleep Disorders Research/Studies

Why Night Guards Aren’t Enough: Addressing the Neurological Roots of Sleep Bruxism with Biofeedback

For millions of people, the sound of teeth grinding is more than an annoyance—it’s a nightly neuromuscular storm. Sleep bruxism, characterized by involuntary clenching and grinding of the jaw during sleep, affects an estimated 8%–15% of adults worldwide.¹ Dentists have long turned to night guards as the standard solution, shielding […]

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Sleep Pharmaceuticals Industry News Narcolepsy

Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025

Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore.   Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]

Alkermes Announces Initiation of Phase 3 Brilliance Studies Evaluating Alixorexton for the Treatment of Narcolepsy Type 1 and Type 2
Sleep Pharmaceuticals Narcolepsy Research/Studies

Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1

Alkermes plc today announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly referred to as ALKS 2680, is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as […]