CBT-I Targeting Co-morbid Insomnia in Patients Receiving rTMS for Treatment-Resistant Major Depressive Disorder

Date Added
January 22nd, 2020
PRO Number
Pro00089725
Researcher
Michael Norred

List of Studies

Keywords
Depression, Mental Health, Psychiatry, Sleep Disorders
Summary

Depression and insomnia occur together in a substantial number of patients. Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but does not help insomnia symptoms in depressed patients. A form of cognitive behavioral therapy (CBT) has been developed that specifically helps with insomnia (CBT-I). We will give CBT-I to patients who are being treated with TMS for depression, who also have insomnia, to determine if it helps insomnia symptoms.

Institution
MUSC
Recruitment Contact
Michael Norred
8438701181
norredm@musc.edu

Sleep for Stroke Management And Recovery Trial

Date Added
May 22nd, 2019
PRO Number
Pro00084906
Researcher
Souvik Sen

List of Studies

Keywords
Sleep Disorders, Stroke
Summary

Investigator-initiated, phase 3 multicenter, prospective randomized open-, blinded-endpoint (PROBE) controlled trial to test whether treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure is effective for secondary prevention and recovery after stroke.

Patients with recent (≤14 days) acute ischemic stroke or high-risk TIA (ABCD2 ≥4) are enrolled during their acute or rehabilitation hospitalization and treated for 6 months. After consent, a portable cardiopulmonary sleep apnea test (the Nox T3) is used to screen for OSA (AHIT3≥10) and to exclude central sleep apnea (where CAI ≥50% of the total AHIT3). aCPAP is then used on one night to determine tolerability (the "run-in" night). Subjects who use the device for ≥4 hours on that night, and do not have excessive treatment-emergent central sleep apnea (CAI remains <10 on aCPAP machine-generated data), are randomized to receive either 6 months of aCPAP plus usual medical therapy, or usual medical therapy alone. Adherence information is provided to subjects in the intervention group, to offer education about treatment and to increase treatment adherence. Subjects and their caregivers also are taught about aCPAP use. Through a centralized service, managed by FusionHealth, adherence to aCPAP is monitored in nearly real time in most cases by wireless means, and supported remotely throughout the treatment period.

Institution
Palmetto
Recruitment Contact
Mihyun Lim
803-545-6078
mihyun.lim@uscmed.sc.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

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

List of Studies

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

Development of the Sleep Research Data Repository (SRDR)

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

List of Studies

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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