Clinical Trials

Minerva Neurosciences Inc's preliminary results from a Phase 1 clinical study showed that treatment with MIN-202, a selective orexin-2 antagonist, resulted in significant improvements in sleep onset and sleep duration in patients with comorbid insomnia related to major depressive disorder (MDD).
Flamel Technologies' second clinical study in healthy volunteers using its proprietary Micropump technology applied to sodium oxybate has achieved the objective of one single dose before bedtime for patients suffering from narcolepsy. This confirms the results of a previous, first-in-man study.
Bright light headset maker Valkee announced the completion of a successful clinical field placebo-controlled double-blind study on alleviating jet lag symptoms of travelers after long haul flights. The results suggest that the light treatment group recovered from the typical experienced jet lag symptoms faster than the control group did.
Jazz Pharmaceuticals plc and Concert Pharmaceuticals Inc announced that Phase 1 clinical data generated to date supports completing the Phase 1 evaluation of JZP-386 at the originally planned highest dose, which was not administered in the first Phase 1 trial due to a technical dosing issue.
The first patients have been enrolled in a Phase 3 clinical trial to assess the safety and efficacy of Jazz Pharmaceuticals plc's Xyrem (sodium oxybate) in children and adolescents aged 7 to 17 who have narcolepsy with cataplexy.
ImThera Medical, Inc., a privately held global medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for its THN3 Clinical Study.
sleep apnea hospital
A study of hospitalized cardiac patients shows that effective treatment with positive airway pressure (PAP) therapy reduces 30-day hospital readmission rates and emergency department visits in patients with both heart disease and sleep apnea.
Galleon Pharmaceuticals announced clinically and statistically significant (p<0.01) results from a double-blind, placebo-controlled clinical proof-of-concept study of its lead investigational compound GAL-021 in normal volunteers.
New research shows that an immunoassay can detect a peptide in urine that is increased in children with sleep apnea. The test could provide a psychologically easier way to determine if a child has sleep apnea, an alternative to spending the night in a sleep clinic.
SleepApneaSurgery
A cutting edge treatment for patients with obstructive sleep apnea—involving shrinking the tongue and reshaping the palate—is being put to the test in a new study led by the Adelaide Institute for Sleep Health (AISH) at the Repatriation General Hospital (RGH).
A Pasadena, Calif-based startup is working on harnessing 3-D technology to create custom CPAP masks for sleep apnea patients via 3-D scanning, smart geometry, and 3-D printing. Metamason has just completed prototyping the Respere Secure CPAP Mask and the Respere Freedom CPAP Adapter.
Jazz Pharmaceuticals plc and Concert Pharmaceuticals Inc have initiated the first Phase 1 clinical trial of JZP-386. JZP-386 is a deuterium-containing analog of sodium oxybate—the active ingredient in Xyrem (sodium oxybate) oral solution.
Toronto-based Revive Therapeutics Ltd today announced positive results from the second half of its Phase 2a proof-of-concept study of REV-001 targeted for the treatment and/or prevention of opioid-induced respiratory depression for patients with sleep apnea in a postoperative setting.
ApneaRX
Positive predictive value for response to custom mandibular advancement device (MAD) therapy based on a trial of prefab device ApneaRX was essentially 100% in a recent proof of concept feasibility pilot.
US Rep. Jim Cooper (TN-D) and US Rep. Cynthia Lummis (WY-R) introduced a bipartisan bill that would require the inclusion and separate analysis of both male and female animals, tissues, and cells in basic research conducted and funded by the National Institutes of Health (NIH).
Tel Aviv, Israel-based Neurim Pharmaceuticals announced today publication of the results from an exploratory Phase 2 randomized placebo-controlled clinical trial evaluating the safety and efficacy of add-on Circadin prolonged release melatonin 2 mg to standard therapy in Alzheimer's disease patients.
text messaging compliance
Umbian Inc, a ResMed company and provider of cloud-based healthcare compliance solutions, participated in a newly released study that shows significant, measurable efficiency gains when using the automated messaging capabilities of its U-Sleep compliance management solution.
Night shift OSA therapy
Advanced Brain Monitoring Inc (ABM) is using a unique strategy to collect compliance data on its novel Night Shift obstructive sleep apnea (OSA) treatment: a crowd-funded clinical trial. Night Shift is a new neck-worn device that treats positional OSA, including severe cases up to an AHI of 60.
Seattle-based television station King5 recently did a segment on a clinical trial in which asthma patients are using CPAP devices.
The current dosing regimen for the standard of care, Xyrem (sodium oxybate), in the United States is two equal, divided doses: the first dose at bedtime and the second dose 2.5 to 4 hours later.