OSA

Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

Retrieved on: 
Thursday, November 2, 2023
Neurology, Venture Capital, Health, Medical Devices, Health Technology, Professional Services, Clinical Trials, Other Health, Supine position, NMES, Research, Clinical trial, Body mass index, Signified and signifier, PAP, Sleep, Somnolence, Health technology, Patient, Randomized controlled trial, Obstructive sleep apnea, AEGIS, Pharmaceutical industry, Birth control

The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy.

Key Points: 
  • The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy.
  • This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).
  • The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals.
  • Signifier Medical Technologies remains dedicated to further research, development, and collaboration with healthcare professionals to continue advancing medical technology and improving patient outcomes.

Adtran launches Satellite Time and Location solution for enhanced GNSS resilience

Retrieved on: 
Thursday, October 26, 2023
Technology, Mobile, Wireless, Finance, Professional Services, 5G, Telecommunications, Software, Networks, Internet, Hardware, Electronic Design Automation, Data Management, Security, Satellite, SATEL, GPS, Government, M.2, Architecture, STL, Multimedia, Two-way satellite time and frequency transfer, GNSS, PTP, PNT, LEO, GM, Satellite navigation device, Adtran, Location

Adtran today launched new synchronization solutions featuring Satellite Time and Location (STL) technology to address the growing vulnerabilities of GPS and other GNSS systems to jamming and spoofing attacks.

Key Points: 
  • Adtran today launched new synchronization solutions featuring Satellite Time and Location (STL) technology to address the growing vulnerabilities of GPS and other GNSS systems to jamming and spoofing attacks.
  • This dual-source approach aligns with zero-trust principles, ensuring resilience even in the event of GNSS disruption.
  • View the full release here: https://www.businesswire.com/news/home/20231026550790/en/
    Adtran’s OSA 5405-S and OSA 5400 STL module will prove key in tackling GNSS vulnerabilities.
  • With this solution, we’re making jamming and spoofing nearly impossible,” said Gil Biran, GM of Oscilloquartz, Adtran.

Apnimed to Present Review of Recent Data on Investigational Pharmacologic Treatment for Obstructive Sleep Apnea at World Sleep 2023

Retrieved on: 
Wednesday, October 18, 2023
MD, Sleep, World Sleep Day, Biology, Obstructive sleep apnea, Pharmaceutical industry

CAMBRIDGE, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that recent data on AD109 (aroxybutynin/atomoxetine) will be featured in an oral presentation at World Sleep 2023 symposium in Rio de Janeiro, Brazil.

Key Points: 
  • CAMBRIDGE, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that recent data on AD109 (aroxybutynin/atomoxetine) will be featured in an oral presentation at World Sleep 2023 symposium in Rio de Janeiro, Brazil.
  • AD109 is a potential first-in-class, novel pharmacologic that is specifically designed to target the key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep.
  • It is currently in Phase 3 clinical trials.
  • “People with obstructive sleep apnea from around the world need a safe and effective oral medication that can be taken at bedtime to address the underlying biology of the disorder,” said Larry Miller, MD, Chief Executive Officer of Apnimed.

American Journal of Respiratory and Critical Care Medicine Publishes Full, Positive Results of Apnimed’s MARIPOSA Study on AD109, an Investigational Oral Drug for Obstructive Sleep Apnea

Retrieved on: 
Tuesday, October 10, 2023
BMI, Nursing care plan, Xerostomia, Food, Female, AJRCCM, Desaturation, American Journal, American Journal of Respiratory and Critical Care Medicine, Confusional arousals, ST, AHI, Safety, Nausea, Insomnia, CPAP, Hypopnea, Fatigue, Research, Obstructive sleep apnea, Sleep, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Critical Care Medicine (journal), IQR, Sleep apnea, Șaeș, Patient, Apnea–hypopnea index, Pharmaceutical industry, Medical imaging

AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.

Key Points: 
  • AD109 has the potential to be the first-in-class oral treatment for people with mild, moderate and severe OSA.
  • The study met its primary endpoint, reduction in Apnea-Hypopnea Index (AHI4, 4% desaturation definition for hypopneas).
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.
  • There were no serious adverse events (SAEs) and no new or unexpected adverse events in the MARIPOSA trial.

Neuromuscular Electrical Stimulation as a Treatment for Obstructive Sleep Apnea Gains Traction With a Recently Announced World Sleep 2023 Congress Symposium

Retrieved on: 
Tuesday, September 26, 2023
Health, General Health, Sleep, Obstructive sleep apnea, Health technology, Clinical trial, Quality of life, Research, World Sleep Day, NMES, Congress, Patient, Treatment, Electricity, Pharmaceutical industry

Since its FDA De Novo authorization in 2021, Signifier Medical has been a leader in applying neuromuscular electrical stimulation (NMES) to obstructive sleep apnea (OSA).

Key Points: 
  • Since its FDA De Novo authorization in 2021, Signifier Medical has been a leader in applying neuromuscular electrical stimulation (NMES) to obstructive sleep apnea (OSA).
  • The NMES-for-OSA World Sleep presentation will be led by doctors Alexandre Abreu, Atul Malhotra, Adrian Williams, Marina Carrasco-Llatas, and Naresh Punjabi.
  • "We look forward to sharing our research and engaging with sleep medicine professionals from around the world at the World Sleep 2023 Congress," added Dr. Naresh Punjabi.
  • The World Sleep 2023 Congress is scheduled for October 20-25, 2023, in Rio de Janeiro, Brazil.

Apnimed to Present New Data on Investigational Oral Therapies for Obstructive Sleep Apnea at ERS International Congress 2023

Retrieved on: 
Wednesday, September 6, 2023
Blood pressure, Science, Hypertension, ERS, International, International Congress on Tuberculosis, Obstructive sleep apnea, MD, Patient, European, Safety, Pharmaceutical industry

CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that a post-hoc analysis of data from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study for AD109 (aroxybutynin/atomoxetine) of one-month duration, will be featured at a poster presentation at the European Respiratory Society’s (ERS) International Congress 2023 in Milan, Italy. A second poster will also be presented on a small exploratory, proof-of-concept trial for another potential compound, AD113 (atomoxetine/mineralocorticoid receptor antagonist), exploring OSA severity and blood pressure in hypertensive patients.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that a post-hoc analysis of data from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study for AD109 (aroxybutynin/atomoxetine) of one-month duration, will be featured at a poster presentation at the European Respiratory Society’s (ERS) International Congress 2023 in Milan, Italy.
  • A second poster will also be presented on a small exploratory, proof-of-concept trial for another potential compound, AD113 (atomoxetine/mineralocorticoid receptor antagonist), exploring OSA severity and blood pressure in hypertensive patients.
  • “ERS 2023 is an opportunity to share the latest data on our investigational oral treatments for obstructive sleep apnea with respiratory experts from around the globe,” said Larry Miller, MD, Chief Executive Officer of Apnimed.
  • “We are excited to be on the forefront of moving the science forward for potential pharmacologic options for OSA to support the millions of people around the world who are unable or unwilling to use currently available treatments.”

Updated Clinical Trial Data Indicates Precision Oral Appliance Therapy with ProSomnus Devices is Non-Inferior to CPAP Therapy for the Treatment of Moderate to Severe Obstructive Sleep Apnea

Retrieved on: 
Wednesday, August 23, 2023
Severity, HNS, CPAP, Obstructive sleep apnea, STAR, OAT, Knokke-Heist, Sleep, Clinical trial, P4, First Line, Medicine, Congress, Patient, AHI, Observation, Entrepreneurship, FDA, Conference, Safety, Pharmaceutical industry

PLEASANTON, Calif., Aug. 23, 2023 (GLOBE NEWSWIRE) -- ProSomnus, Inc. (NASDAQ: OSA), a leading CPAP alternative for the treatment of Obstructive Sleep Apnea (“OSA”), announced updated clinical trial data, presented at the ProSleep 2023 Users Conference earlier this month. The updated data indicate that the First Line Obstructive Sleep Apnea Treatment study (FLOSAT) is on track to achieve all endpoints.

Key Points: 
  • The updated data indicate that the First Line Obstructive Sleep Apnea Treatment study (FLOSAT) is on track to achieve all endpoints.
  • FLOSAT is an ongoing, prospective, independent, head-to-head study comparing the effectiveness of precision OAT as first-line treatment versus CPAP therapy.
  • In July , ProSomnus announced plans to design a head-to-head clinical trial comparing precision OAT and HNS in treating patients with severe OSA.
  • “The updated data and analysis from FLOSAT is validation that precision oral appliance therapy with ProSomnus devices is an effective front-line treatment for moderate to severe OSA,” said Len Liptak, Co-Founder and Chief Executive Officer of ProSomnus.

Incannex Submits IND Application to the US FDA for IHL-42X for Obstructive Sleep Apnoea

Retrieved on: 
Friday, July 21, 2023
Psychology, Ohio State University, Sleep apnea, US Foods, University, Obstructive sleep apnea, Acetazolamide, Sleep, Clinical trial, Trial of the century, ASX, Research, Dronabinol, Investigational New Drug, MD, Patient, Medical Center, Principal, FDA, IND, Food, Safety, Pharmaceutical industry, Neurology

The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients.

Key Points: 
  • The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients.
  • The FDA review process for an IND application involves evaluation of the scientific, clinical, and safety aspects to ensure that the proposed clinical trial meets regulatory requirements.
  • The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 clinical trial investigating IHL-42X for the treatment of Obstructive Sleep Apnoea (‘OSA’).
  • This announcement has been approved for release to ASX by the Incannex Board of Directors.

71% of Self-identified Snorers Have Never Consulted a Healthcare Professional

Retrieved on: 
Wednesday, June 28, 2023
Partnership, Heart failure, Diabetes, CPAP, Obstructive sleep apnea, Education, Stroke, Sleep, Choking, DIY, Snoring, Hypertension, Apnea, Dentist, Patient, Somnolence, Prodege, Pharmaceutical industry

In addition to daytime sleepiness, OSA is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes.

Key Points: 
  • In addition to daytime sleepiness, OSA is associated with serious comorbidities, including heart failure, stroke, hypertension, morbid obesity and type 2 diabetes.
  • Patients with untreated OSA are 23 times more likely to suffer a heart attack and four times more likely to have a stroke.
  • It is estimated that more than one billion people worldwide and over 74 million people in North America suffer from OSA.
  • “Inaction among snorers, despite strong awareness that snoring is linked with OSA and comorbidities, is one of the novel and alarming findings from this survey.

Incannex Appoints Principal Investigators for IHL-42X Phase 2/3 Clinical Trial

Retrieved on: 
Friday, June 16, 2023
Psychology, Ohio State University, Sleep apnea, Pi, University, Obstructive sleep apnea, NSF, Sleep, Clinical trial, Consultant, Lead, American Academy, ASX, Research, Doctor of Philosophy, CNN, Pain, Today, MSNBC, American Academy of Sleep Medicine, National Sleep Foundation, MD, Patient, Medical Center, Ethics, Institutional review board, Principal, FDA, IND, Safety, Chair, Pharmaceutical industry, Neurology

Site recruitment and selection in the US and other jurisdictions is an iterative process and Incannex plans to recruit approximately 45 sites across multiple jurisdictions for this pivotal trial.

Key Points: 
  • Site recruitment and selection in the US and other jurisdictions is an iterative process and Incannex plans to recruit approximately 45 sites across multiple jurisdictions for this pivotal trial.
  • Dr John D Hudson, Principal Investigator – FutureSearch Trials of Neurology, Austin, Texas
    J. Douglas Hudson, MD, is board certified in Neurology and Sleep Medicine.
  • Regarding the IHL-42X trial, Dr Hudson said: “Clinical trials for novel formulations of medication are newsworthy for any specialty and sleep medicine is no exception.
  • Regarding the IHL-42X phase 2/3 clinical trial Dr Rosenberg said: “Incannex has developed a sound, rational, scientific protocol to determine the efficacy and safety of IHL-42X in subjects with obstructive sleep apnea."