Sleep for Stroke Management and Recovery Trial Save

Date Added
June 4th, 2019
PRO Number
Pro00088514
Researcher
Christine Holmstedt

List of Studies


Profiles_link
Keywords
Sleep Disorders, Stroke, Stroke Recovery
Summary

This research is being done to figure out whether treatment for sleep apnea, in people who have had a stroke or TIA, improves recovery from stroke, and helps prevent future stroke, heart problems, and death.

The intervention being tested is called continuous positive airway pressure (CPAP). The U.S. Food and Drug Administration (FDA) has approved CPAP for the treatment of obstructive sleep apnea.

A total of 15,010 patients are expected to enroll in this study and be screened for sleep apnea across about 110 sites in the United States. About 3,000 are expected to participate in the second part of the study, in which sleep apnea treatment is tested. Participation in this study is approximately 6 months.

Institution
MUSC
Recruitment Contact
Vicki Streets
843-792-8606
streetsv@musc.edu

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension Save

Date Added
November 13th, 2018
PRO Number
Pro00082995
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of an oxybate mixed-salts oral solution or placebo for treatment of Idiopathic Hypersomnia. Idiopathic Hypersomnia (IH) is a sleep disorder in which a person is excessively sleepy during the day and has great difficulty being awakened from sleep. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18-70 years old with a diagnosis of Idiopathic Hypersomnia (IH) within the last five years, and not due to other medical conditions such as Narcolepsy, restless leg syndrome, and uncontrolled hypothyroidism. A minimum of 140 study subjects will be randomized across all sites with 72 randomized to the study drug and 72 to the placebo drug. The study treatment period from screening to follow-up will last approximately 42 weeks, requiring nine visits. An overnight stay might be required to confirm the diagnosis of IH.

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

A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy Save

Date Added
August 28th, 2018
PRO Number
Pro00077667
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
Sleep Disorders
Summary

The study is designed to assess the efficiency and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension or a placebo for the treatment of excessive daytime sleepiness and cataplexy, sudden and uncontrollable muscle weakness or paralysis, in subjects with narcolepsy. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18 years of age or older. A total of 264 study subjects will be randomized across all sites with 132 randomized to the study drug and 132 to the placebo drug. The study treatment period from screening to follow-up will last approximately 17 weeks. Requiring 9 visits with 4 overnight stays.

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

A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors Save

Date Added
May 19th, 2016
PRO Number
Pro00055721
Researcher
Amarinthia Curtis

List of Studies

Keywords
Cancer, Sleep Disorders
Summary

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life. Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Development of the Sleep Research Data Repository (SRDR) Save

Date Added
March 1st, 2011
PRO Number
Pro00009339
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
Anxiety, Genetics, Mental Health, Psychiatry, Sleep Disorders, Stress Disorders
Summary

The Sleep Research Data Repository (SRDR) aimed to systematically collect, analyze and store for future research sleep and sleep disorders related biological and psychological information. It will include sleep physiological measurements and the results of interviews, questionnaires, and laboratory tests. The SRDR will contain sleep related information obtained from healthy subjects and patients with psychiatric, substance abuse, neurological disorders, or any medical conditions associated with sleep disturbances. SRDR data will be made available to current and future IRB-approved investigators associated with this protocol.

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

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