Sleep Medicine

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder

   Scottsdale/Phoenix, Ariz.

   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 correlates with clinical severity

   and/or disease duration, and whether there is a left-right difference in the density of a-syn pathology.

   Specific Aim 2. Determine, with a second SMG biopsy in previously biopsied PD and RBD subjects,

   whether a-syn pathology density increases, decreases, or remains the same after a 1.5-2 year time

   interval and whether there is a correlation between a-syn SMG pathology and clinical and/or disease

   progression.

   Specific Aim 3. Determine whether a-syn pathology density in skin punch biopsies correlates

   with clinical measures and increases, decreases, or remains the same after a 1.5-2 year time

   interval, and whether the density and changes over time correlate with those found in SMG

   biopsies.

2. Synucleinopathies

   Rochester, Minn.

   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).

3. Developing Interventions for Healthy Sleep in Native American Families

   Rochester, Minn.

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

4. Evaluation of the Effects of Caffeine, Via the ACE2 Receptor, on Clinical Severity of COVID-19 Disease

   Jacksonville, Fla.

   The purpose of this study is to assess levels of caffeine intake among patients who tested positive for COVID-19 infection and compare that to disease severity.

5. A Prospective Registry for Patients with REM Sleep Behavior Disorder and Polysomnographic REM Sleep without Atonia and Controls

   Rochester, Minn.

   The purpose of this study is to follow patients with REM sleep behavior disorder (RBD) over time and learn which types of RBD patients may be at risk of developing other diseases.

6. A Study to Evaluate Sleep for Stroke Management and Recovery

   Rochester, Minn.

   The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

7. A Study to Evaluate the Use of a Smartphone App for Stroke Patients with Obstructive Sleep Apnea

   Rochester, Minn.

   The purpose of this study is to evaluate the use of a smartphone app for stroke patients with obstructive sleep apnea in order to better use their positive airway pressure (PAP) therapy.

8. Detection of Vascular and Inflammatory Plasma Biomarkers in Patients Diagnosed with Obstructive Sleep Apnea and MRI-defined Cerebral Small Vessel Disease

   Jacksonville, Fla.

   The purpose of this study is to evaluate plasma biomarkers of vascular function and inflammation in patients with newly-diagnosed Obstructive Sleep Apnea (OSA) and pre-existing imaging evidence of Cerebral Small Vessel Disease (CSVD).

9. Obstructive Sleep Apnea Among Somali-Americans

   Rochester, Minn.

   The purpose of this study is to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

10. A Study to Evaluate the Safety, Tolerability and Effectiveness of V117957 in Subjects with Insomnia Associated with Alcohol Cessation

    Rochester, Minn.

    The purpose of this study is to evaluate the safety, tolerability and effectiveness of V117957, compared to placebo, in subjects with alcohol use disorder (AUD) who experience insomnia associated with alcohol cessation.