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

NCT ID: NCT05933603

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-29
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Down Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ato-oxy

0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin

Group Type: EXPERIMENTAL

Atomoxetine and Oxybutynin (ato-oxy)

Intervention Type: DRUG

0.5 mg/kg atomoxetine (max 40 mg) and 5 mg oxybutynin by mouth nightly

Interventions

Atomoxetine and Oxybutynin (ato-oxy)

0.5 mg/kg atomoxetine (max 40 mg) and 5 mg oxybutynin by mouth nightly

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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)

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Lauren Melcher

Role: primary

lmelcher@arizona.edu

520-403-0383

Other Identifiers

R33HL151254

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1908864846v2

Identifier Type: -

Identifier Source: org_study_id