Obstructive Sleep Apnea study: Ato-oxy vs Oxygen
Official title Endotype DIrected Treatment for OSA in Down Syndrome
ClinicalTrials.gov ID: NCT07280468
What this study is testing
What is ato-oxy?
An investigational nightly medication combination being studied for obstructive sleep apnea in people with Down syndrome.
Also referred to as atomoxetine, oxybutynin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares a drug combo (atomoxetine and oxybutynin) with a personalized approach that may give either the drug combo or oxygen, to find out which treatment reduces sleep apnea and improves quality of life.
- Who it's for
- Children and adults aged 6 to 17 with Down syndrome who have obstructive sleep apnea.
- What's involved
- Participants will receive either the drug combo or, if chosen by the personalized method, oxygen therapy. They will have sleep tests, quality‑of‑life surveys, behavior and cognition assessments, and side‑effect monitoring.
- Time commitment
- The study lasts 12 months, with assessments at the start and after 12 months; participants will attend visits at five sites during that period.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- Age 6 years or older
- Down syndrome diagnosis
- Any gender or ethnicity
- Adults without a legally authorized representative must have a caregiver/support person that can co-sign consent and complete study questionnaires.
You likely can't join if
- Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent/caregiver...
- MAO inhibitor use
- Urinary retention
- Seizure disorder
- Untreated or inadequately treated hypothyroidism
- Significant traumatic brain injury
See the full eligibility criteria
- Age 6 years or older
- Down syndrome diagnosis
- Any gender or ethnicity
- Adults without a legally authorized representative must have a caregiver/support person that can co-sign consent and complete study questionnaires.
- Currently using and adherent to PAP therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent/caregiver report)
- MAO inhibitor use
- Urinary retention
- Seizure disorder
- Untreated or inadequately treated hypothyroidism
- Significant traumatic brain injury
- Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year
- History of current, untreated depression
- History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)
- 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- San Diego, California, United States
- Miami, Florida, United States
- Park Ridge, Illinois, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; San Diego, California, United States; Miami, Florida, United States; Park Ridge, Illinois, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.