At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism

Part of paid clinical trials in Portland, Oregon.

Sponsor
Sequitur Health Corp.
Study ID
NCT06953505
Status
Recruiting
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Conditions

  • Ammonia; Metabolic Disorder
  • Fatty Acid Oxidation Disorder
  • Organic Acidemias
  • Urea Cycle Disorders

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ammonia Study Device — DIAGNOSTIC_TEST
    Ammonia study device for capillary ammonia measurement

Study Details

The goal of this observational study is to learn if people with certain ammonia metabolism disorders will measure their ammonia levels at home. The main question it aims to answer is: • Will participants measure their ammonia every day? Participants will be asked to: * Attend two in-person study visits at the clinic. * Measure temperature, heart rate, and blood oxygen every day. * Complete a short survey every day. * Measure ammonia every day.

Key Dates

Start date
Sep 23, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Ammonia Device

Primary Outcome Measure

Percentage of daily ammonia measurements completed. [ Time Frame: through individual participant study completion - approximately 240 days per participant with an optional 120 day additional extension period available. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239-3098
Amy C. Yang, M.D.
503-494-8307
Amy C Yang, M.D. (PRINCIPAL_INVESTIGATOR)
Brian Scottoline, M.D., Ph.D (SUB_INVESTIGATOR)
Kimberly Kripps, M.D. (SUB_INVESTIGATOR)

Find similar trials in Portland, OR

By research site
Oregon Health & Science University· Portland, OR

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