Usability, Validity and Biomarker Discovery for Wearable & Mobile Device Measurements of Neurologic Disorders

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)

Disease Progression Study

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease

Detailed Description

This is a longitudinal, observational Study to Determine Usability, Analytical and Clinical Validity and Biomarker Discovery for Wearable and Mobile Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders. The Disease Progression Study part in Parkinson's Disease has a duration of approximately 12 months.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Koneksa Health; Phone Number: 551-866-0025; Email: KH007@koneksahealth.com

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
      • Parkinsons Disease And Movement Disorders Center Of Boca Raton
      • Contact: Nicolle Thomas; Phone Number: 2 561-392-1818; Email: nthomas@parkinsonscenter.org
      • Contact: Karla Arias; Phone Number: 2 561-392-1818; Email: karias@parkinsonscenter.org
      • Principal Investigator: Stuart H Isaacson, MD
    • DeLand, Florida, United States, 32720
      • Recruiting
      • Accel Research Sites DeLand
      • Principal Investigator: Bruce Rankin, MD
      • Contact: Erica Santoni; Phone Number: 109 386-785-2400; Email: erica.santoni@accelclinical.com
      • Contact: Tiffany Martinez-Torres; Phone Number: 357 386-785-2400; Email: tifany.martinez@accelclinical.com
    • Largo, Florida, United States, 33777
      • Recruiting
      • Accel Research Sites St Petersburg-Largo
      • Principal Investigator: Deborah Burke, MD
      • Contact: Adrianna Cygler; Phone Number: 813-877-8839; Email: acygler@accelclinical.com
      • Contact: Gail McDonnell; Phone Number: 813-877-8839; Email: gmcdonnell@accelclinical.com
    • Orlando, Florida, United States, 32825
      • Recruiting
      • N1 Research LLC
      • Principal Investigator: Ramon Rodriguez, MD
      • Contact: Carem Acosta; Phone Number: 4030 407-916-0304; Email: CAcosta@NeurologyOne.com
      • Contact: Victor Lameda; Phone Number: 4080 407-916-0304; Email: vlameda@NeurologyOne.com
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Quest Research Institute
      • Contact: Sarah Margott; Phone Number: 248-957-8940; Email: sarah.morgott@questri.com
      • Contact: Ashley Murphy; Phone Number: 248-957-8940; Email: ashley.murphy@questri.com
      • Principal Investigator: Peter LeWitt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease I. participants without diagnosed obstructive sleep apnea II. participants with diagnosed obstructive sleep apnea

Description

Inclusion Criteria:

1. All study participants

   1.1 Male or female between 18 years and 85 years of age

   1.2 Body mass index (BMI) 18 - 40 kg/m2

   1.3 Participant is judged to be in adequate health other than Parkinson's Diagnosis per Principal Investigator (PI) assessment

   1.4 Participant or caregiver has demonstrated ability to perform satisfactory in-clinic and remote procedures during the screening period

   1.5 Usual nightly total sleep time > 6 hours

   1.6 Participant demonstrates ability to perform satisfactory in-clinic and mobile data collection and respond to questionnaires during the screening training period

   1.7 Parkinson's disease diagnosis defined as:

   1.7.1 Clinically established Parkinson's Disease (PD)

   1.7.2 H&Y stage 1 and 2

2. In addition to a PD diagnosis, for participants with obstructive sleep apnea (OSA). OSA is defined as:

2.1 Participant demonstrates ability to perform satisfactory in-clinic and at-home mobile data collection and respond to questionnaires during the screening training period

2.2 Diagnosed with moderate to severe obstructive sleep apnea with an apnea hypopnea index (AHI) >= 15 at time of diagnosis

2.3 Participants diagnosed with obstructive sleep apnea but identified as central or complex over the course of this study will be noted but still included as part of this cohort

2.4 Confirmed moderate-severe sleep apnea diagnosis within the last 10 years

2.5 Participants are still eligible for this study if they are on continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP). Duration and frequency data must be documented.

Exclusion Criteria:

1. Unable to commit to 12 months of data collection.
2. Planning to enroll in a clinical trial for disease. modifying therapy that will overlap with the duration of this study.
3. Patients with Parkinsonism due to drugs(s) and or toxin(s)
4. Patients with increased risk of falling as > 6 falls in the preceding 12 months.
5. Urine drug screen positive for opiates, phencyclidine (PCP), cocaine, and amphetamines
6. Subjects who regularly partake in binge drinking as defined by 4 or more drinks for women or 5 or more drinks for men on an occasion per the investigators assessment.
7. Current, recent (within the past 6 months), or seeking treatment for a substance-related disorder, excluding medical or recreational marijuana.
8. Current or recent (within the past 6 months) diagnosis of a moderate or severe substance use disorder (excluding caffeine) according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria. Nicotine use disorder is excluded only if it has an effect on sleep (i.e., a subject who routinely awakens at night to smoke). Medical or recreational marijuana is not included in this exclusion criterion.
9. Use of any over the counter (OTC) or prescription medications that could affect the evaluation within a time period prior to the Baseline visit corresponding to at least 5 half-lives of the drug(s) or planned use of such drug(s) at some point. Examples of excluded medications include OTC stimulants and methylphenidate, amphetamines, modafinil, armodafinil, sodium oxybate, pemoline, pitolisant, bupropion, and opioids. Medications should be discontinued such that, in the opinion of the investigator, the subject has returned to his/her baseline level of daytime sleepiness at least 7 days prior to the Baseline visit. Medical or recreational non-inhaled marijuana is not included in this exclusion criterion.
10. Subjects with severe cardiopulmonary, hepatic, renal, or musculoskeletal disease such that Activities of Daily Living (ADLs) are adversely impacted.
11. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety or efficacy assessments.
12. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening.
13. Participant has a history of neoplastic disease. Exception (1) participant with an adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) participants with other malignancies which have been successfully treated > 5 years prior to screening without evidence of recurrence.
14. Currently participating in another clinical trial or who participated in a previous clinical trial and received any investigational product treatment within 60 days or within at least 5 half-lives of previous investigational product prior to screening visit.
15. Participants who are pregnant or breastfeeding.
16. History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
17. Intracranial metallic or magnetic devices (e.g., cochlear implant, deep brain stimulator).
18. Pacemaker or any implanted device
19. Any history of an experimental therapy (e.g., antisense oligonucleotide, cell transplantation or experimental brain surgery).
20. Current untreated or unstable depressive disorder or a serious mood disorder requiring hospitalization.
21. Other primary degenerative dementia or neurodegenerative conditions outside of the specific study arm.
22. Other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, other laboratory values etc.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Function as Measured by the Neuroscience Toolkit app-based Assessments	Gait, balance, upper limb function, pronation/supination, finger tap, postural, kinetic and resting tremor	Baseline Day 1 through Day 365 End of Participation
Motor Function in the Context of Daily Living	As measured by gait and balance calculated from walk periods detected using wrist-worn device	Baseline Day 1 through Day 365 End of Participation
Speech Measures	Diadochokinetic rate as measured by the repeated phrase task, monotonicity, search time, and description duration as measured by the Picture Description task, articulation rate, speaking rate, articulatory precision, monotonicity, regulation of voicing and pause rate as measured by the Sentence Reading, and maximum phonation time, pitch instability and harmonic strength as measured by the Sustained Phonation task	Baseline Day 1 through Day 365 End of Participation
Cognitive Measures as measured by Cambridge Cognition assessments via the Koneksa mobile application	Paired Associates Learning (PAL) test, Pattern Recognition Memory (PRM) test, Reaction Time (RT) test, Spatial Working Memory (SWM) test	Baseline Day 1 through Day 365 End of Participation
Daytime Measurements via Wrist-Worn Device	Oxygen saturation, heart rate variability, superficial temperature, distance walked, average speed, steps, metabolic equivalent of task	Baseline Day 1 through Day 365 End of Participation
Patient Reported Outcomes	Patient Global Impression of Change (PGI-C) and Patient Global Impression of Severity (PGI-S)	Baseline Day 1 through Day 365 End of Participation
Participant Diary	Time in and out of bed, number of daytime naps, use of any medications or supplements taken to promote sleep or wakefulness or treat symptoms of central nervous system (CNS) disorders	Baseline Day 1 through Day 365 End of Participation
Daytime Sleep	Number of naps and duration of each measured by wrist-worn device, measures from sleep-related electronic patient reported outcomes (ePROs)	Baseline Day 1 through Day 365 End of Participation
Objective Measures of Nighttime Sleep	Nighttime sleep measured by vital signs, heart rate variability plus actigraphy plus oxygen saturation from wrist-worn device	Baseline Day 1 through Day 365 End of Participation
Usability	Participant and/or caregiver ease of use and satisfaction for the wrist-worn device and neuroscience toolkit app-based assessments	Baseline Day 1 through Day 365 End of Participation
Other Assessments	Site clinical care team, participant, and/or caregiver likelihood to recommend the neuroscience toolkit	Baseline Day 1 through Day 365 End of Participation

Collaborators and Investigators

• Sponsor: Koneksa Health

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Nervous System Diseases
• Other Study ID Numbers: KH007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie results in a publication
• IPD Sharing Time Frame: Upon preliminary analysis (if applicable) and end of study.
• IPD Sharing Access Criteria: Publications will be shared with Clinical Site Investigators and industry professionals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No