INFO at: https://clinicaltrials.gov Clinical Trial #: NCT05412004
Brief Summary
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI-1 and those who are and plan to stay on PAP therapy in GPI-2.
INFO at: https://clinicaltrials.gov
Trial #: NCT04652882
TITLE: Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
Brief Summary
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and a matching placebo in male and female participants with DSWPD.
INFO at: https://clinicaltrials.gov Clinical Trial #: NCT104861038
Title: Study Using Negative Pressure to Reduce Apnea (SUPRA)
Device: aerSleep II
Detailed Description:
This is a multicenter, single-arm, prospective, observational intervention study to determine the safety and effectiveness of the aerSleep II System. Up to 200 subjects will be enrolled at up to ten study sites in the United States to ensure that approximately 79 subjects who are termed initial responders can be evaluated after 24 weeks of home use with the aerSleep II device. As part of the screening and prior to intervention, home sleep testing will be performed to establish baseline apnea-hypopnea index (AHI). Subjects meeting study criteria will wear the aerSleep II device at home. After a 1-week period of acclimation, subjects will have a second HST (HST #2). Initial responders with a ≥50% reduction in AHI from baseline with an AHI <20/hour will be continued on home treatment. Non-responders will be discontinued from the study. After 12 weeks, subjects will have an interim home sleep study. After 24 weeks of home use, subjects will have HST #4 to determine the primary effectiveness endpoint.
INFO at: https://clinicaltrials.gov
Trial #: NCT PENDING
TITLE: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK-861 in Healthy Adult and Elderly Subjects and Subjects With Narcolepsy Type 1
INFO at: https://clinicaltrials.gov
Trial #: NCT PENDING
TITLE: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of TAK-861 in Healthy Adult and Elderly Subjects and Subjects With Narcolepsy Type 1
Trial #: NCT04794491
TITLE: An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Brief Summary:
The rationale for the interventional, open-label, single-arm design of JZP258-401 is to evaluate the clinical experience in participants with narcolepsy transitioning treatment from Xyrem to XYWAV.