Who is eligible for clinical trial NCT06219629?

Participants must meet the protocol's inclusion criteria for Parkinson Disease. The stated age range is 18 Years to 85 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06219629 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-09-02

Parkinson's Disease Progression Study (NCT06219629)

A Two Part, Observational Basket Study to Determine Usability, Validity and Biomarker Discovery for Mobile EEG, Wearable and Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders (LEARNS)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Koneksa Health

🩺 Plain-English Summary (8th-Grade Level)

Disease Progression Study

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (20 items).

Location: University of Colorado Health Neurosciences Center — Aurora, Colorado

Age range: 18 Years to 85 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Aged ≥18 years to ≤85 years of age.
Body mass index (BMI) ≥18 to 40 kg/m2.
In adequate health based on medical history and physical examination (other than PD) undertaken following standard care procedures and presenting minimal risk for taking part in the study, per investigator assessment.
Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period.
Clinically established PD, consistent with Postuma et al (Mov Disord; 2015).
H\&Y stage 1 or 2.

Usually NOT eligible if any of the following apply:

Exclusion criteria:
Unable to commit to 12 months of data collection.
Planning to enroll in a clinical trial for disease modifying therapy that will overlap with the duration of this study.
Parkinsonism due to drugs(s) and or toxin(s).
Increased risk of falling, defined as \>6 falls within the 12 months prior to screening.
Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, or amphetamines.
Regular binge drinking, defined as ≥4 alcoholic drinks for women or ≥5 alcoholic drinks for men, per investigator assessment.
Current or recent (within 6 months prior to screening) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to Diagnostic and Statistical Manual of Mental Disorders-5 criteria. Note that nicotine use disorder is an exclusion criterion only if it has an effect on sleep (i.e., a participant who routinely awakens at night to smoke), and medical or recreational marijuana is not included in this exclusion criterion.
Severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that activities of daily living are adversely impacted.
History of neoplastic disease, with the exception of (1) an adequately treated basal cell carcinoma or carcinoma in situ of the cervix; (2) other malignancies which have been successfully treated \>5 years prior to screening without evidence of recurrence.
Currently participating in another clinical trial, or previous participation in a clinical trial in which an investigational product was received within 30 days prior to screening or within at least 5 half-lives of the investigational product.
Current or planned pregnancy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 Sites)

University of Colorado Health Neurosciences Center — Aurora, Colorado
Parkinsons Disease And Movement Disorders Center Of Boca Raton — Boca Raton, Florida
Accel Research Sites DeLand — DeLand, Florida
Accel Research Sites St Petersburg-Largo — Largo, Florida
N1 Research LLC — Orlando, Florida
Augusta University Health Movement Disorder Clinic — Augusta, Georgia
University of Kansas Medical Center Parkinson's Disease and Movement Disorder Center — Kansas City, Kansas
Beth Israel Deaconess Medical Center — Boston, Massachusetts
Quest Research Institute — Farmington Hills, Michigan
Cleveland Clinic — Las Vegas, Nevada

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Parkinson Disease clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗