RECRUITING

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.

Official Title

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

Quick Facts

Study Start:2023-09-29

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05933603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. 2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)	1. Presence of central sleep apnea on polysomnography (central AHI ≥ 5) 2. Currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 3. Monoamine oxidase inhibitor use 4. Urinary retention 5. Prematurity \< 32 weeks estimated gestational age 6. Seizure disorder 7. Untreated or inadequately treated hypothyroidism 8. Significant traumatic brain injury 9. Congenital heart disease and not cleared to participate by the patient's cardiologist 10. History of current, untreated depression 11. History of liver disease 12. 3+ or greater tonsillar hypertrophy 13. Positive urine pregnancy test 14. Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%) 15. Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5) 3. Absence of OSA defined as total AHI \<5 on baseline polysomnography

Inclusion Criteria

Exclusion Criteria

1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit.
2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

1. Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
2. Currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report)
3. Monoamine oxidase inhibitor use
4. Urinary retention
5. Prematurity \< 32 weeks estimated gestational age
6. Seizure disorder
7. Untreated or inadequately treated hypothyroidism
8. Significant traumatic brain injury
9. Congenital heart disease and not cleared to participate by the patient's cardiologist
10. History of current, untreated depression
11. History of liver disease
12. 3+ or greater tonsillar hypertrophy
13. Positive urine pregnancy test
14. Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%)
15. Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5)
3. Absence of OSA defined as total AHI \<5 on baseline polysomnography

Contacts and Locations

Study Locations (Sites)

University of Arizona

Tucson, Arizona, 86721

United States

Collaborators and Investigators

Sponsor: University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea
Down Syndrome