The purpose of this study is to evaluate the safety and effectiveness of suvorexant versus placebo (an inactive substance) on individuals with alcohol use disorder experiencing insomnia during abstinence. Participants will be 18 years of age or older. Twenty-four participants will have a 50:50 chance to the study drug or placebo. The study participation will last approximately six weeks, requiring four visits.
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.
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.
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.
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.