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

Silhouette
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
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

URCC 14040: 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
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

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 (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

Development of the Sleep Research Data Repository (SRDR) Save

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

Silhouette
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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