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Sleep Disorders

Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.

  • Sleep Dysfunction and Neurocognitive Outcomes in Adolescent ADHD
    Study Type: Observational
    Start Date: August 1, 2016
    Location: Durham, North Carolina
    Eligibility: Ages 13–17, Accepts Healthy Volunteers

    This study seeks to characterize sleep physiology in adolescents with and without Attention deficit hyperactivity disorder (ADHD) and its relationship to differential neurocognitive and clinical outcomes within these groups.

  • Integrated Chronotherapy for Perinatal Depression
    Study Type: Interventional
    Start Date: January 1, 2014
    Location: Providence, Rhode Island
    Eligibility: Females, Ages 18–40, Does Not Accept Healthy Volunteers

    Perinatal depression is a common and serious mood disorder that increases morbidity and mortality in new mothers and results in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who suffer from circadian rhythm disruption are at risk for perinatal depression. This R34 Pilot Effectiveness Studies and Services Research Grant seeks to test whether an Integrated Chronotherapy (IC) intervention can be implemented in an outpatient psychiatry setting to improve treatment outcomes for patients with perinatal depression. IC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms, sleep-wake behavior, social rhythms, and arousal. We will assess the feasibility, safety, and acceptability of an IC intervention for perinatal depressin by testing the treatment in expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. We will randomize patients to either: (a) usual care (UC, n = 20) or (b) IC+UC (n = 20). IC+UC will have pregnancy and postpartum components and will be administered via an individualized case formulation approach tailored to each patient. After a baseline assessment, IC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication administered by a perinatal psychiatrist and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the IC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. We will assess the safety profile of the IC intervention with evaluation of side effects/adverse events. Importantly, the study will also examine the putative mechanisms by which IC is hypothesized to work and the "dose" of IC received by patients in the IC+UC group. All participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and sleep duration and timing. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks gestation), at 36 weeks gestation, and at postpartum week 6. This pilot will allow us to refine the IC intervention for future integration into various clinical settings and establish an infrastructue for a larger (R01-scale) trial, including measuring acceptability of IC among UC clinicians and implementing web-based data collection to facilitate data sharing in the planned R01. Perinatal IC could have major public health impact due to the high prevalence of perinatal depression and its negative effects on mothers and their children. This project represents a first step toward achieving this goal, as it will provide the pilot data necessary to prepare for a larger scale intervention study focused on providing non-pharmacologic therapies and improving outcomes for women with perinatal depression.

  • Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
    Study Type: Interventional
    Start Date: January 1, 2014
    Location: New York, New York
    Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

    This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.

  • Treatments for Insomnia: Mediators, Moderators and Quality of Life
    Study Type: Interventional
    Start Date: September 1, 2013
    Location: Palo Alto, California
    Eligibility: Ages 60 and Older, Accepts Healthy Volunteers

    The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).

  • A Sleep-Oriented Intervention for Suicidal Behaviors
    Study Type: Interventional
    Start Date: May 1, 2013
    Location: Stanford, California
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    An open-label trial to investigate the use of a behavioral insomnia treatment for suicidal ideation.

  • Reducing Suicidal Ideation Through Insomnia Treatment
    Study Type: Interventional
    Start Date: September 1, 2012
    Locations: Augusta, Georgia; Durham, North Carolina; Madison, Wisconsin
    Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

    Epidemiologic reports have linked insomnia to suicidal ideation and suicide death. However, no studies have determined whether treating insomnia decreases the risk of suicidality. We have new data indicating that (1) the link between insomnia and suicidal ideation holds true in clinical trials of depressed insomniacs, (2) dysfunctional cognitions about sleep are related to suicidal ideas, and (3) treatment of insomnia with hypnotics leads to a reduction of suicidal ideation. We now propose to test whether cautious use of hypnotics in suicidal, depressed insomniacs may reduce suicide risk in a multi-site clinical trial.