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Review of Current Studies for Researchers

With four Principal Investigators driving the HFH Sleep Research Center, all with unique research backgrounds and sleep research topics of interest, our team has a robust catalog of current studies with funding from the National Institutes of Health and the pharmaceutical industry. We have previously received funding from the Centers for Disease Control and Prevention and the American Academy for Sleep Medicine. Click on the study titles below to learn more about them.

NIH Funded Trials

Clinical Trials

Industry Supported Trials

COACH

Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Principal Investigator: Philip Cheng, PhD

Despite the effectiveness of digital Cognitive Behavioral Therapy for insomnia (dCBT-I), there are significant disparities when it comes to treatment adherence and completion, particularly in vulnerable populations such as those with less access to socioeconomic resources. COACH is designed to identify an adaptive nurse coaching system of enhancing dCBT-I that fits patients' individual needs, increases treatment engagement, and closes that utilization gap. We have recently joined forces with Medicaid in an exciting partnership to research the effectiveness of this "enhanced dCBT-I."

For more information, email us at abayone1@hfhs.org.

INSPIRE

Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms
Principal Investigator: David Kalmbach, PhD
Over half of pregnant women experience clinical insomnia, which increases risk for maternal depression, suicidality, and impaired postpartum bonding. Emerging data support effectiveness of cognitive-behavioral and mindfulness-based approaches for alleviating insomnia during pregnancy, which can also benefit postpartum sleep. The INSPIRE trial evaluates the real-world effectiveness of cognitive-behavioral therapy for insomnia (CBTI) and a mindfulness-based sleep program designed for pregnant women (Perinatal Understanding of Mindful Awareness for Sleep; PUMAS) in a sample of pregnant women with insomnia and depression.
For clinicians interested in the PUMAS manual, learn more about it and access a free download here.
For more information, email us at ResearchSleep@hfhs.org

REACT

Sleep reactivity as a novel mechanism in Shift Work Disorder

Principal Investigator: Philip Cheng, PhD

Circadian misalignment is generally considered a core mechanism of Shift Work Disorder (SWD); however, our prior research suggests that there may be another key mechanism might be sleep reactivity. REACT is designed to establish sleep reactivity as an independent and clinically significant mechanism in SWD. If our hypotheses are supported, these results would generate more effective treatment plans that target multiple relevant mechanisms to improve sleep health and the lives of night shift workers.

For more information, email us at shabash1@hfhs.org.

SHIFT

Innovations in wearable technology for correcting circadian misalignment in shift work disorder

Principal Investigator: Philip Cheng, PhD

This study aims to establish the role of consumer-based wearable technology and mobile health application in personalized treatment of Shift Work Disorder. The protocol includes the use of data from the Apple Watch processed through a biomathematical model of the human central pacemaker (i.e., the SCN) for near real-time tracking of circadian phase. This then enables personalized light therapy schedules that respond dynamically to daily changes in behavioral. Feedback from participating night shift workers was used during Part 1 of the study to improve the mobile application. In Part 2, the effectiveness of the personalized treatment is assessed by comparing it to a non-personalized and static light therapy schedule.

For more information, email us at gpanicc1@hfhs.org.

STRIDE

Sleep to reduce incident depression effectively

Principal Investigator: Christopher Drake, PhD

STRIDE is a sequential multiple assignment randomized trial to investigate the efficacy of a stepped-care model of insomnia treatment. Specifically, we are investigating the use of cognitive behavioral therapy for insomnia (CBT-I) to reduce symptoms of insomnia and prevent the onset of depression. Participants were enrolled in one of two internet treatment groups that focus on insomnia, and those in the CBT-I group used a digital program called Sleepio. Though participant enrollment has closed, STRIDE is still ongoing, and has informed the design of studies like COACH and PIVOT.

For more information, email us at jiqal1@hfhs.org.

Sleep and OUD

Dual-Orexin Antagonism as a Mechanism for Improving Sleep and Drug Abstinence in Opioid Use Disorder

Principal Investigators: Timothy Roehrs, PhD and Mark Greenwald, PhD

Opioid illegal use and misuse are producing extremely costly sequelae (e.g. overdoses, ED visits, deaths) at unprecedented levels. FDA-approved medications for treating opioid use disorder are effective, but there is a significant unmet need for alternatives especially relapse prevention. Insomnia is a clinically significant, but understudied, correlate/predictor of relapse to substance use. Yet, most medications for treating insomnia have limited efficacy and can produce side effects. The orexin (OX) system plays a key role in sleep and substance use, offering a promising avenue for study. This project will address whether orexin antagonism is a mechanism that can directly improve outpatient opioid abstinence (i.e. independent of opioid detoxification-related sleep disturbance), or whether OX antagonism corrects sleep deficiencies and indirectly improves opioid abstinence.
For more information, email us at atabor2@hfhs.org.

PIVOT

Preventing Insomnia and Depression with Nurse Coaching in Individuals with Low Socioeconomic Position

Principal Investigator: Philip Cheng, PhD

This study seeks to test a preventive intervention for both insomnia and depression in those with lower socioeconomic position. Specifically, we propose to target the progression between acute insomnia to chronic insomnia. Our long-term goal is to establish highly feasible interventions to reduce sleep health disparities in vulnerable populations. The overall objective of this proposal is to test the effectiveness of a one-shot telehealth pCBT-I in those with low SES to prevent chronic insomnia and its sequalae. Our central hypothesis is that pCBT-I delivered during prodromal insomnia will be effective in preventing chronic insomnia and incident depression.
For more information, email us at abatra1@hfhs.org.

SAIL

A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers

Principal Investigator: Philip Cheng, PhD

Almost all night shift nurses experience circadian misalignment, a phenomenon that occurs due to the mismatch between the night shift sleep-work schedule and the body-clock. This study tests the implementation of a personalized mobile health application (Arcashift) that uses data collection from a mobile phone and activity trackers to 1) assess individual shift worker’s body-clock timing, and 2) make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule.
For more information, email us at jrusse12@hfhs.org.

LunAIRo

Phase 3 Randomized Double-Blind Placebo-Controlled 1-Year Parallel-Arm Study to Compare A Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea

Principal Investigator: Christopher Drake, PhD

LunAIRo is a phase 3 investigational drug study designed to compare a fixed dose combination of Aroxybutynin and Atomoxetine (AD109) to a placebo in a population with obstructive sleep apnea who cannot tolerate CPAP. The sponsor, Apnimed, is a pharmaceutical company focused on developing the first approved oral medications to treat OSA. The phase 2 study, MARIPOSA, showed promising results for AD109. AD109 is designed as a single pill taken nightly at bedtime, to help the muscles of the throat prevent the blockage of the airway that typically occurs with OSA.
For more information, email us at csagong1@hfhs.org.

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