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

• ClinicalTrials.gov Identifier: NCT06219629
• Recruitment Status: Recruiting
• First Posted: January 23, 2024
• Last Update Posted: April 5, 2024
• Sponsor: Koneksa Health
• Information provided by (Responsible Party): Koneksa Health

Tracking Information

• First Submitted Date: December 4, 2023
• First Posted Date: January 23, 2024
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: February 20, 2024
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 12, 2024)

• Motor Function as Measured by the Neuroscience Toolkit app-based Assessments [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Gait, balance, upper limb function, pronation/supination, finger tap, postural, kinetic and resting tremor
• Motor Function in the Context of Daily Living [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  As measured by gait and balance calculated from walk periods detected using wrist-worn device
• Speech Measures [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  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
• Cognitive Measures as measured by Cambridge Cognition assessments via the Koneksa mobile application [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Paired Associates Learning (PAL) test, Pattern Recognition Memory (PRM) test, Reaction Time (RT) test, Spatial Working Memory (SWM) test
• Daytime Measurements via Wrist-Worn Device [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Oxygen saturation, heart rate variability, superficial temperature, distance walked, average speed, steps, metabolic equivalent of task
• Patient Reported Outcomes [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Patient Global Impression of Change (PGI-C) and Patient Global Impression of Severity (PGI-S)
• Participant Diary [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  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
• Daytime Sleep [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Number of naps and duration of each measured by wrist-worn device, measures from sleep-related electronic patient reported outcomes (ePROs)
• Objective Measures of Nighttime Sleep [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Nighttime sleep measured by vital signs, heart rate variability plus actigraphy plus oxygen saturation from wrist-worn device
• Usability [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Participant and/or caregiver ease of use and satisfaction for the wrist-worn device and neuroscience toolkit app-based assessments
• Other Assessments [ Time Frame: Baseline Day 1 through Day 365 End of Participation ]
  Site clinical care team, participant, and/or caregiver likelihood to recommend the neuroscience toolkit

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Usability, Validity and Biomarker Discovery for Wearable & Mobile Device Measurements of Neurologic Disorders
• Official Title: 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)
• Brief Summary: Disease Progression Study
• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Parkinson Disease
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 12, 2024): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2025
• Estimated Primary Completion Date: August 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Koneksa Health; 551-866-0025; KH007@koneksahealth.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06219629
• Other Study ID Numbers: KH007
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: All individual participant data that underlie results in a publication
• Supporting Materials: Study Protocol
• Time Frame: Upon preliminary analysis (if applicable) and end of study.
• Access Criteria: Publications will be shared with Clinical Site Investigators and industry professionals.

• Current Responsible Party: Koneksa Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Koneksa Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Koneksa Health
• Verification Date: March 2024