Actively Recruiting
Pilot Study of At Home Ammonia Monitoring in Patients With an Inborn Error of Ammonia Metabolism
Led by Sequitur Health Corp. · Updated on 2026-05-27
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Sequitur Health Corp.
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether people with certain inherited ammonia metabolism disorders can successfully measure their ammonia levels daily at home. The study focuses on understanding participants' ability to regularly use a new ammonia measurement device and complete daily health monitoring. This research aims to improve management of conditions like urea cycle disorders and other metabolic diseases that affect ammonia processing in the body. Participants will use an investigational ammonia device that measures total ammonia from a single drop of blood using a reusable instrument and single-use cartridge. They will be asked to measure their ammonia levels daily, along with temperature, heart rate, and blood oxygen. The study includes two in-person clinic visits and an optional extension period, with monitoring lasting approximately 240 days, extendable by another 120 days. During the study, participants will complete daily surveys and record their health measurements to help researchers track adherence and gather data. The main outcome measured is the percentage of daily ammonia tests completed. Researchers will also analyze descriptive statistics and correlations over the study period to better understand home monitoring feasibility and patterns. Participants' involvement lasts around 8 months, with optional continued participation for an additional 4 months.
CONDITIONS
Brief Title
At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed ammonia disorder such as ornithine transcarbamylase deficiency, systemic primary carnitine deficiency, type I citrullinemia, argininosuccinic aciduria, isolated methylmalonic acidemia, type II citrullinemia, propionic acidemia, isovaleric acidemia, multiple acyl-CoA dehydrogenase deficiency, pyruvate carboxylase deficiency, argininemia (arginase deficiency), carbamoyl phosphate synthase I deficiency, dihydrolipoamide dehydrogenase deficiency, lysinuric protein intolerance, hyperornithinemia-hyperammonemia-homocitrullinuria, carnitine-acylcarnitine translocase deficiency, carbonic anhydrase VA deficiency, or N-acetyl glutamate synthetase deficiency
- Able to read and understand English
- Age 12 years or older
You will not qualify if you...
- Currently incarcerated
- Having a non-inborn error of metabolism medical condition causing abnormal ammonia metabolism, such as end stage liver disease
- Unable to read or understand English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 240 days with an optional additional 120 day extension
Participants use the ammonia study device at home to measure their blood ammonia levels daily.
Daily measurements at home
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Actively Recruiting
Research Team
M
Marylaura Thomas, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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