Sleep Disorders

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
Narcolepsy Sleep Pharmaceuticals

U.S. FDA 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

Takeda announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) and granted Priority Review for oveporexton (TAK-861) for the treatment of narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to address the underlying orexin deficiency that causes […]

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab
Clinical Insights Home Sleep Testing (HST) Industry News Polysomnography Respiratory

Patch-Based Onera Sleep Test Demonstrates PSG Accuracy Outside the Sleep Lab

Onera Health has announced the publication of a multicenter validation study of its Onera Sleep Test System (STS) in the Journal of Clinical Sleep Medicine, the official journal of the American Academy of Sleep Medicine. The study demonstrated that the patch-based Onera STS home-polysomnography (hPSG) performs comparably to gold-standard in-lab […]

kricket cpap kpap sleepres
Sleep Disorders Central Sleep Apnea CPAP/Interfaces Obstructive Sleep Apnea PAP Therapy & Ventilation Systems Product/Vendor Updates

FDA Clears Kricket Positive Airway Pressure Device with KPAP

SleepRes, Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Kricket PAP device, powered by Kairos Positive Airway Pressure (KPAP)™ for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lbs. The SleepRes PAP system is intended for home, hospital/institutional, […]

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 […]

Inspire Medical Systems, Inc. Publishes Inspire V Data at ISSS/AAO-HNS Meetings
Research/Studies Obstructive Sleep Apnea

Inspire Medical Systems, Inc. Publishes Inspire V Data at ISSS/AAO-HNS Meetings

Inspire Medical Systems, Inc. published Inspire V clinical outcomes data from its Singapore clinical study, as well as the Company’s limited market release in the United States, including single-site experience at two leading centers. These data will be presented at the American Otolaryngology-Head and Neck Surgery (AAO-HNS) and International Surgical […]