Reach for Equity in Pediatric Obstructive Sleep Evaluation: Pilot Testing of the REPOSE Navigation Intervention

Date Added
September 30th, 2023
PRO Number
Pro00127932
Researcher
Phayvanh Pecha

List of Studies


Keywords
Sleep Disorders
Summary

This research study aims to find out the effect of REPOSE, a screening and patient navigation intervention, on the receipt of equitable care among racially and ethnically diverse children with Sleep Disordered Breathing (SDB).

In this study, parents and their child will participate in the REPOSE Patient Navigation Intervention, where the child will be screened for SDB at their pediatric well-visit. If the child's screening is positive, the parent will be asked if they and the child would like to be a part of the REPOSE Patient Navigation Intervention. The REPOSE patient navigation will utilize a patient navigator that will a) ID and address dynamic individual barriers to care, b) provide education and social support for parents and children who are diagnosed with SDB, and c) coordinate care between medical providers and parent/child to complete evidence-based care (e.g., sleep study, tonsillectomy). The navigator will follow patients to completion of recommended treatment or up to 6 months after enrollment.

Patient Navigation has been proven to benefit adult cancer patients but has not been tested in pediatric patients with sleep-disordered breathing. This study is an effort to demonstrate whether patient navigation is effective in increasing the receipt of equitable care for children with SDB. The REPOSE Intervention is designed to guide parents of children with SDB through and around barriers in the complex healthcare system to achieve timely diagnosis and treatment.

Institution
MUSC
Recruitment Contact
Kelly Templeton
336-486-5608
templeke@musc.edu

A Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients with Idiopathic Hypersomnia (IH)

Date Added
April 5th, 2023
PRO Number
Pro00127155
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The current study will investigate the safety, efficacy and pharmacokinetics of serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH). The study may inform about the best dosing regimen, optimal dose range, duration of treatment, and secondary endpoints for a future Phase 3 study.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@MUSC.edu

A Study to Assess the Long-term Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy

Date Added
February 14th, 2022
PRO Number
Pro00116774
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of Narcolepsy. The open-label treatment period is 24 weeks, which will be followed by a double-blind treatment period of 4 weeks, for a total of up to 28 weeks with 13 visits. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. Study drug will be administered as a pill.

Institution
MUSC
Recruitment Contact
Richard Simmons
8437927439
simmr@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy

Date Added
December 13th, 2021
PRO Number
Pro00113095
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of Narcolepsy. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. The study will last approximately 28 weeks with 8 visits for an individual subject. Study drug will be administered as a pill.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@MUSC.edu



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