Clinical Trials

The primary aim in Phase I of the study is to evaluate whether the proposed sensing technology was demonstrated to be exceptionally effective. In Phase II of the study, the following aims are proposed to mature the prototype hardware into a production ready system, to finalize processing software and develop interfaces for end users / clinicians, and to validate system performance against current state-of-the-art system in a human subject study.

The microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease, and could be used to predict disease onset, monitor response to treatment and predict prognosis. The purpose of this study is to show that human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns. They may ultimately be related to disease risk.

The purpose of this study is to gather information on sleep duration and sleep patterns in Native American families.

The purpose of this study is to investigate the overnight hemodynamic changes and impact of energy drinks on sleep in young people. 

As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.

The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.

Thermal comfort and subsequent sleep quality will improve with the use of bedding that incorporates thermoregulation technology, in comparison to standard bedding products.

Background Sleep deprivation of medical staff and especially trainees has been a concern for many years. There is growing evidence that lack of sleep by staff and trainees increases risks of acute and chronic illness and injury. Concern about judgement and performance have led to significant regulation and reduction of  trainee work hours and frequency of call over the past two decades. There is conflicting evidence whether these changes have had a positive impact on patient care. There is a need to objectively measure the range of sleep obtained and activity performed by staff and resident physicians across different work shift ...

The purpose of this study is to verify that a relatively inexpensive, readily available activity monitor can be used in sleep research.  Specifically, the interest is on children and adolescents as they will be the focus of future research.

The purpose of this study is to demonstrate proof-of-concept feasibility for Mayo OMNI physiologic monitor correlation with sleep-wake measures obtained from the current gold-standards of actigraphy and polysomnography. 

The purpose of this study is to measure electrophysiologic biosensor signals recorded from patients. We will measure electrophysiologic and biosensor signals in patients with neurological, psychiatric, sleep and medical disorders, and compare them to measurements in age- and sex-matched controls without these disorders, and analyze medical records  to determine possible demographic or clinical predictors for observed differences in signal characteristics between patients and controls. The goal is to define biosensor signal characteristics and alterations in human subjects and their associations with clinical characteristics and to explore changes in biosensor characteristics over time in selected individuals.

The purpose of this study is to investigate the relationships among sleep health characteristics, sleep disorders, and cognitive functioning after heart transplantation, which will critically inform the development of precision sleep health interventions to promote optimal cognitive functioning for this complex population.

The purpose of the study is to conduct qualitative interviews of participants in a sleep restriction study who were allowed free snacking to learn about their self-observations regarding their eating motivations and behaviors.

The purpose of this study is to demonstrate the feasibility of collecting KING Devick Test (KDT) data and confirm the relationship/association of utilizing this brain function test in the evaluation of obstructive sleep apnea (OSA) suspect patients.

The purpose of this study is to determine the effect of natural light exposure or lack of exposure in the work-space on physician cognitive and physical performance, subjective sleepiness, and mood.

The primary purpose of this study is to assess the effects of a daily single oral dose of 20 mg tasimelteon compared to placebo on Sleep Onset (change from baseline) in participants over a 28-day period, as measured by sleep diary.

The purpose of this study is to evaluate the clinical presentations, polysomnographic features, treatment patterns of all children with narcolepsy in multiple CTSA (Clinical and Translational Science Award) centers.Comparison between recent cases (2009-June 30, 2012) and old cases (prior to 2009) will be performed.  To assess the role of infection and other triggering factors in early onset Narcolepsy.

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

The purpose of this study is to evaluate the safety, tolerability and effectiveness of BTD-001 in subjects with idiopathic hypersomnia (IH) as reflected by changes in mental fogginess, sleep, functional, and quality-of-life measures.

The purpose of this study is to determine the frequency of sleep behavior disorder by age group and sex in Olmsted County MN.

The purpose of this study is to evaluate whether use of the app to recommend positive airway pressure (PAP) masks reduces patient-initiated request for mask changes during the first 90 days of PAP use., and to evaluate whether use of the app results in improved patient satisfaction with PAP experience during the first 90 days of PAP use.

The purpose of this study is to document the long-term outcomes of secondary (symptomatic) narcolepsy in the pediatric patient population at the Mayo Clinic using chart review and mailed questionnaire.  

Primary objective: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by an improvement in the Maintenance of Wakefulness Test (MWT) score. Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression of Severity (CGI-S) score related to excessive daytime sleepiness (EDS) and the change in total Epworth Sleepiness Scale (ESS) score.

Insufficient sleep may be one of the most common, and most preventable, obesity risk factors. The investigators wish to determine whether 14 nights of modest sleep restriction results in increased energy balance, thus potentially increasing the risk of obesity. The investigators hypothesize that sleep restriction will result in increased energy balance.

The purpose of this study is to evaluate the effect of low sodium oxybate (LSO) on total sleep time as measured by 24-hour polysomnography.

The secondary objective of this study is to evaluate the effect of low sodium oxybate on total sleep time as measured by Nestsense EEG earbuds, Axivity device, and patient sleep diary entries.

An exploratory objective of this study is to evaluate the effect of low sodium oxybate on patient reported outcomes, micro/macro sleep stages, daily activity levels/steps, and degree of association between outcomes measured in the study.

The purpose of this study is to identify patients preference of one mode of noninvasive ventilation (BPAP-ST) over another (IPAP) in patients being treated for respiratory issues related to neuromuscular disease.

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

The purpose of this study is to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

The purpose of this pilot study is to evaluate our RN CBT-I program outcomes and determine utility of this program as a high-value care model targeted specifically to our sleep center patient population.

Hypothesis: PIRS will improve from baseline to 2 month follow up

The purpose of this study is to assess the safety and effectiveness of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

The purpose of this study is to evaluate the safety and effectiveness of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH) age ≥ 18 years.  

The purpose of this study is to compare the agreement of WatchPAT300 to the gold standard in-laboratory polysomnography (PSG) at detecting central events in adult patients referred to the sleep laboratory for suspected obstructive and/or central sleep apnea.

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

Determine 1) the magnitude of SMG and skin a-syn density change over time, 2) the

improvement in adequate tissue acquisition doing bilateral SMG biopsies, 3) any laterality differences between

SMG gland a-syn density, 4) correlate a-syn density and changes in density between SMG and skin biopsies

Specific Aim 1. Determine, with bilateral submandibular gland (SMG) biopsies in 30 clinically

diagnosed subjects with Parkinson’s disease (PD) and 20 clinically probable REM sleep behavior

disorder (RBD) subjects whether bilateral biopsies improve the rate of acquisition of adequate

glandular tissue, whether alpha-synuclein (a-syn) SMG pathology ...

The purpose of this study is to assess the safety and effectiveness of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.

The purpose of this study is to determine whether the risk for sleep-disordered breathing in infants with myelomeningocele (a severe form of spina bifida) differs among those who underwent fetal vs. postnatal surgery, and to examine the link between sleep-disordered breathing and neurodevelopment.

To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation using the Scrambler device in alleviating uncomfortable sensations and urge to move in patients with restless legs syndrome/Willis Ekbom Disease (RLS/WED).

The purpose of this research is to understand sleep disturbances in  patients with primary immunodeficiency.

Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide ...

The purpose of this study will be looking at patients diagnosed with post-COVID, continue to experience symptoms and report experiencing sleep issues.  Each study participant will receive a Brain Activity Sensing Headband system with an APP, wearable activity tracking device, and earbuds to participate in the study to complete study activies.  Study participation lasts approximately 6 weeks involving wearing the headband system in the evenings before bed for a minumum of 10 minutes, participating in 4 weeks of sleep meditation before bed with the system, and wear the activity tracking device to track sleep.  The earbuds may be used with participation in the meditations.  Participants ...

The purpose of this study is to assess the safety and effectiveness of Ferric Carboxymaltose Injectafer for the treatment of restless legs syndrome.

The purpose of this study is to evaluate the impact of pitolisant on Excessive daytime sleepiness in patients with Prader-Willi syndrome.

The purpose of this study is to establish a registry of RBD patients, develop quantitative biological and functional measures of synucleinopathy burden, and establish a formal process to evaluate candidate neuroprotective agents.

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

The purpose of this study is to retrospectively review the charts of 200 patients for whom overnight oximetry data, pulmonary function tests, as well as echocardiographic data have been obtained as part of routine clinical assessment. In so doing, the hope is to assess the risk of sleep disorder breathing, as evidenced by the oxygen desaturation index (ODI) on overnight oximetry assessment.

The purposes of this study are to demonstrate the feasibility of assessing delayed dim light melatonin onset (DLMO) in patients with comorbid AUD and DSWPD utilizing a combination of questionnaires and laboratory assay of salivary melatonin levels, and to examine the impact of low-dose melatonin on SOL and overall sleep quality in patients withcomorbid AUD and DSWPD with delayed DLMO compared to those without delayed DLMO.

The purpose of this study is to determine the baseline chronotype patterns (with Morningness-Eveningness Questionnaire (MEQ) ) among inpatients with Major depressive disorder and then compare the chronotype distribution with the control group.

The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.

The purpose of this study is to compare prevalence of sleep apnea and sleep disturbance in post-COVID-19 infected patients who had been symptomatic to COVID negative participants as controls. A sleep testing device will assess for sleep disordered breathing and the results will be aggregated to compare if a significant increase (any difference) in the prevalence of sleep disordered breathing diagnosis between the two groups. Sleep questionnares data will be obtained. A second part of this study will involve using a Fitbit consumer wearable device to obtain sleep and activity data on participants for 2 months in duration. 

This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.

This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.

The objectives of this study are to examine the prevalence of comorbid sleep disordered breathing (SDB) and insomnia in post-MI patients enrolled in cardiac rehabilitation (CR), to assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without, and to determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR than those without.

The purpose of this study is to identify the association between untreated OSA and chronic insomnia and their association with cognitive decline, increased Alzheimer's Disease (AD) and vascular pathology.

Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed. In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive ...

Most individuals with rapid eye movement (REM) sleep behavior disorder (RBD) develop additional
neurological symptoms and are subsequently diagnosed with overt synucleinopathies, including dementia with
Lewy bodies (DLB), Parkinson disease (PD), and multiple system atrophy (MSA), indicating that RBD
represents a prodromal stage of synucleinopathy. RBD therefore offers a window of opportunity to intervene
with neuroprotective treatments at the earliest stages of disease when treatment is most likely to be effective.
Recognizing the importance of early intervention, key federal agencies focused on neurodegenerative disease
have proposed high priority recommendations for prodromal aspects of synucleinopathies, including
specifically RBD, to prepare for clinical trials. The North American Prodromal Synucleinopathy ...

The goals of the study are to prospectively evaluate clinical and laboratory biomarkers of multiple system atrophy and Parkinson’s disease at early clinical disease, at a premotor stage (PAF), and even at a prodromal stage (RBD).

Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).