Elly Mackay Blog

First Patient Dosed in Sleep Apnea Pill Phase 2 Clinical Trial 0

First Patient Dosed in Sleep Apnea Pill Phase 2 Clinical Trial

The first patient has been dosed in a Phase 2 clinical trial evaluating AD109, Apnimed’s first-in-class oral pharmaceutical under development for the treatment of obstructive sleep apnea (OSA).

“There is a clear unmet need for an approach that addresses the underlying cause of OSA,” says Larry Miller, MD, Apnimed CEO, in a release. “Evidence from earlier proof-of-concept studies demonstrated the potential of our oral therapy as an option for the treatment of OSA. We anticipate data from this Phase 2 study in the first half of 2021 and plan to move forward into a Phase 3 registrational study in 2021.”

AD109 combines a selective norepinephrine reuptake inhibitor (atomoxetine) with a novel new chemical entity (NCE)—a selective antimuscarinic (aroxybutynin). Proof-of-concept for the AD109 program was demonstrated by Apnimed in a Phase 2, parallel group dose-finding study of the combination of atomoxetine and racemic oxybutynin. That study provided evidence of safety and efficacy in the treatment of OSA with a norepinephrine reuptake inhibitor (NRI) + antimuscarinic combination in 140 patient—indicating that a pharmacologic approach could treat the underlying pathophysiology of OSA. AD109 …

First Patient Enrolls in Central Sleep Apnea Trial to Assess Alternative Transvenous Lead Location for Remedē Implant 0

First Patient Enrolls in Central Sleep Apnea Trial to Assess Alternative Transvenous Lead Location for Remedē Implant

Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, on August 18, 2020 became the first site in the world to successfully enroll a patient and complete the protocol in JANUS, a clinical trial for sleep apnea. The trial seeks to explore whether transvenous stimulation can improve airway physiology. In this first patient, Sheetal Chandhok, MD, the investigator and implanting physician, was able to demonstrate feasibility in this novel approach for managing sleep apnea.

The primary objective of the JANUS trial, sponsored by Respicardia, is to assess acute changes in respiration and airway physiology during sleep. The trial is being conducted in patients with central sleep apnea who are undergoing a Remedé system implant, which uses transvenous stimulation to reduce the periods of the breathing pauses. The JANUS trial is conducted during the implantation of commercially available device called the Remede System, a diaphragm pacemaker that works to stimulate breathing in the same way that the brain would. The Remede System was first implanted at Bryn Mawr Hospital by Chandhok, a cardiac electrophysiologist, in January 2019.

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South Shore University Hospital Opens New Sleep Center 0

South Shore University Hospital Opens New Sleep Center

Residents of Suffolk County, New York, can now have their sleep quality evaluated in hotel-like rooms in a sleep center affiliated with South Shore University Hospital (SSUH) in Bay Shore.

The 12-room center relocated from the hospital to 125 Kennedy Drive in Hauppauge and features an expanded footprint to better serve the growing need to treat sleep-related disorders such as sleep apnea, insomnia, and narcolepsy.

This center, which is accredited by the American Academy of Sleep Medicine, has six sleep specialists who offer in-lab diagnostic sleep studies and in-lab treatment for sleep disorders. The center also helps patients with at-home diagnostic sleep studies.

[RELATED: Texas’ Dell Children’s Opens New Sleep Lab]

“This new, larger facility with state-of-the-art technology and experienced staff will go a long way toward helping patients get more restful, restorative sleep,” says Donna Moravick, NP, SSUH’s executive director, in a release.

“While some people might brush off their partner’s or family member’s snoring, it can be the sign of a very serious, underlying medical issue,” says Gary Wohlberg, MD, medical director of the sleep center, in a …

$15M Euro Grant May Propel Iceland Into a Sleep Apnea Research Hub 0

$15M Euro Grant May Propel Iceland Into a Sleep Apnea Research Hub

The European Union (EU)’s Horizon 2020 Framework Programme for Health, demographic change, and wellbeing has selected an interdisciplinary, international sleep apnea research and development project led by scientists at Reykjavik University (pictured) for a 15-million Euro grant.

“Sleep Revolution” aims to revolutionize research, diagnosis, and treatment of obstructive sleep apnea (OSA) and related disorders. With almost 40 international collaborating partners from academia and industry, it will develop machine-learning techniques to better estimate the severity and treatment needs for OSA, to improve health outcomes and quality of life. With the commitment of the European Sleep Research Society and the Assembly of National Sleep Societies, with its over 8,000 members, the project further aims to create new standardized international guidelines for sleep medicine.

[RELATED: Beyond AHI: The Future of Endophenotyping in Sleep Medicine]

The project involves building a powerful database consisting of data from sleep measurements of 30 thousand individuals, collected in Iceland and around Europe. Additional data will be collected utilizing smart watches, questionnaires, sleep-measuring devices, and neuropsychological tests. Furthermore, a digital platform will be developed for scientists, health professionals, and …

Sommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea 0

Sommetrics Gets FDA Breakthrough Designation for AerSleep II for Sleep Apnea

Sommetrics negative pressure aerSleep II device has received FDA “Breakthrough Device” designation. The breakthrough program allows for additional FDA feedback to sponsors during the pre-marketing phase but does not alter the basic requirements for market authorization. It is intended to help patients gain more timely access to products that have the potential to provide more effective therapy than currently available options for medical conditions which are either life-threatening or irreversibly debilitating.

“This designation recognizes the real promise of aerSleep II as a first-in-class therapy for people with sleep apnea who are unable to benefit from current therapies,” says Kingman Strohl, MD, program director, sleep medicine, University Hospital, Cleveland, and professor of medicine, Case School of Medicine, in a release. “AerSleep II is simple to use and comfortable, with new design features which can translate into effectiveness and better compliance with treatment. Also, unlike some other alternatives to standard CPAP therapy, aerSleep II has been shown in previous clinical studies to be effective in patients with all degrees of sleep apnea severity.”

AerSleep II applies negative pressure over the external surface …

Beyond AHI: The Future of Endophenotyping in Sleep Medicine 0

Beyond AHI: The Future of Endophenotyping in Sleep Medicine

Researchers make strides in scaling obstructive sleep apnea endotyping, which may guide therapy choices once more data becomes available.  

By Lisa Spear

The pathophysiology behind every patient’s obstructive sleep apnea (OSA) is unique. Not every airway collapses in the same way or for the same reasons, but often OSA cases are treated and studied without considering the specificities of each person’s anatomy.

In the research community, there’s been a decent amount of interest in OSA phenotyping to hone in on the causes of sleep apnea. Now, an emerging computer program could change the way sleep scientists think about the study of sleep-disordered breathing by making endophenotyping easier to deploy on a large scale. The new tool called PUPpy uses algorithms to analyze large data sets from polysomnograms (PSG) to derive respiratory endotypes, according to recently published research in the journal SLEEP.

“With the respiratory endotyping that we have been working on, our goal is to help doctors answer why different patients have sleep apnea as opposed to whether or not they have it. That is not currently available …

Sleep Apnea & Autoimmune Disease: A New Study Explores Cytokines 0

Sleep Apnea & Autoimmune Disease: A New Study Explores Cytokines

New research by University of Georgia scientists sheds light on why people with obstructive sleep apnea may have associated autoimmune disorders. The results could lead to better approaches to treatment and possibly new drug therapies.

The study, led by Bradley Phillips, PharmD, BCPS, FCCP, builds on previous research showing that obstructive sleep apnea (OSA) increases the risk for autoimmune diseases. Immune system disorders are a result of either low activity or over activity of the immune system and include well-known conditions such as lupus and rheumatoid arthritis. The molecular links to autoimmunity are poorly understood.

“This paper looks at what may be the underlying mechanisms that increase someone’s risk for autoimmune disorders because they have untreated obstructive sleep apnea,” says Phillips, director of UGA’s Biomedical and Health Sciences Institute, in a release.

Phillips and the team looked at four cytokines—proteins involved in cell signaling—associated with autoimmune disease. They evaluated the cytokines in three groups of adults: patients with untreated OSA, patients with OSA who were receiving treatment, and people who did not have OSA. The study results revealed abnormal levels …

AADSM: Dentists Can Order Home Sleep Tests 0

AADSM: Dentists Can Order Home Sleep Tests

A new position statement from the American Academy of Dental Sleep Medicine supports qualified dentists’ ability to order or administer HSTs. Not everyone agrees.

By C.A. Wolski

The American Academy of Dental Sleep Medicine (AADSM) recently made its position clear:

“[I]t is within the scope of practice for a qualified dentist, defined by the American Dental Association (ADA) as a dentist treating sleep-related breathing disorders who continually updates his or her knowledge and training of dental sleep medicine with related continuing education, to order or administer home sleep apnea tests (HSATs).”1

This position statement, which is diametrically opposed to the stance of the American Academy of Sleep Medicine (AASM), has already had a polarizing effect. But David Schwartz, DDS, president of the AADSM and statement co-author, isn’t swayed: Taking a strong stance was exactly the point.

“Effective positions are intended to be bold and often groundbreaking,” Schwartz says. “The number of dentists deemed qualified by the AADSM to treat patients diagnosed with sleep apnea and snoring has increased to more than 1,600. Correspondingly, the number of undiagnosed patients …

ProSomnus Is a 2020 Red Herring Top 100 North America Finalist 0

ProSomnus Is a 2020 Red Herring Top 100 North America Finalist

Oral appliance manufacturer ProSomnus Sleep Technologies has been selected as a finalist for Red Herring’s Top 100 North America award, a technology industry prize.

Red Herring’s editorial team takes into account criteria including disruptive impact, proof of concept, financial performance, market footprint, and quality of management during a during months-long process.

Previous Top 100 finalists have included Alibaba, Facebook, Google, Skype, SuperCell, Spotify, Twitter, and YouTube.

The Top 100 North America has become not only a springboard for some of tech’s biggest names, but a valued and trusted tool for venture capitalists, experts, and analysts predicting trends.

“Selecting finalists for this year’s Top 100 has proved more difficult than ever,” says Alex Vieux, publisher and chairman of Red Herring, in a release. “North America has been tech’s beating heart for years—but never have I seen such an exciting, disruptive, and innovative generation as we have in 2020.

[RELATED: These Sleep Companies Made the Inc. 5000 2020]

“ProSomnus Sleep Technologies fully deserves its place among our finalists, and I have every confidence it will make a significant impact in the tech …

Healthy Sleep Patterns Linked to Lower Heart Failure Risk 0

Healthy Sleep Patterns Linked to Lower Heart Failure Risk

Adults with the healthiest sleep patterns had a 42% lower risk of heart failure regardless of other risk factors compared to adults with unhealthy sleep patterns, according to new research published in the American Heart Association’s flagship journal Circulation.

The study defines healthy sleep patterns as: rising in the morning, sleeping 7-8 hours a day and having no frequent insomnia, snoring, or excessive daytime sleepiness.

Heart failure affects more than 26 million people, and emerging evidence indicates sleep problems may play a role in the development of heart failure.

This observational study examined the relationship between healthy sleep patterns and heart failure and included data on 408,802 UK Biobank participants, ages 37 to 73 at the time of recruitment (2006-2010). Incidence of heart failure was collected until April 1, 2019. Researchers recorded 5,221 cases of heart failure during a median follow-up of 10 years.

[RELATED: This Simple Blood Test Can Help Predict Cardiometabolic Disease Risk in OSA Patients]

Researchers analyzed sleep quality as well as overall sleep patterns. The measures of sleep quality included sleep duration, insomnia, and snoring …