Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
230 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-24
Study Completion Date
2027-12-30
Brief Summary
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The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).
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Detailed Description
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This will be a randomized, single-blind 6-month Phase-2 clinical trial that compares the impact of oxygen therapy during sleep on measures of cognition, behavior, quality of life, cardiac structure and function, and sleep in children with Down Syndrome(DS) with moderate to severe obstructive sleep apnea.
The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations.
Children who agree to participate in the study will be screened for eligibility based on history, physical examination, and review of medical records including history of congenital heart disease and Pulmonary Hypertension (PHTN), and use of Continuous Positive Airway Pressure (CPAP). Children eligible for the study are those with persistent obstructive apnea after adenotonsillectomy or children with obstructive sleep apnea without adenotonsillar hypertrophy or in situations when parents refuse adenotonsillectomy.. The enrollment PSG eligibility will be determined by central scoring of either a research Polysomnography (PSG). In addition to an oxygen titration PSG, which determines responsiveness to oxygen, participants will be asked to wear a wrist actigraph and undergo neurocognitive testing, echocardiography, physical examination, anthropometry, and venipuncture. Caregivers will complete questionnaires to assess their child's emotional, physical, social, and school functioning, sleep quality; child's behavior and cognitive function, and will complete a sleep diary that is used concurrently with their child's use of a wrist actigraph. The latter includes caregiver completion of the "Behavior Rating Inventory of Executive Function" (BRIEF2), a co-primary outcome.
At 3 months, caregivers will complete the BRIEF2. At 6 months, all baseline studies and a PSG will be repeated.
At baseline, demographic data will be collected, including information on residential address (for use in geocoding).
The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations.
Children who agree to participate in the study will be screened for eligibility based on history, physical examination, and review of medical records including history of congenital heart disease and Pulmonary Hypertension (PHTN), and use of Continuous Positive Airway Pressure (CPAP). Children eligible for the study are those with persistent obstructive apnea after adenotonsillectomy or children with obstructive sleep apnea without adenotonsillar hypertrophy or in situations when parents refuse adenotonsillectomy.. The enrollment PSG eligibility will be determined by central scoring of either a research Polysomnography (PSG). In addition to an oxygen titration PSG, which determines responsiveness to oxygen, participants will be asked to wear a wrist actigraph and undergo neurocognitive testing, echocardiography, physical examination, anthropometry, and venipuncture. Caregivers will complete questionnaires to assess their child's emotional, physical, social, and school functioning, sleep quality; child's behavior and cognitive function, and will complete a sleep diary that is used concurrently with their child's use of a wrist actigraph. The latter includes caregiver completion of the "Behavior Rating Inventory of Executive Function" (BRIEF2), a co-primary outcome.
At 3 months, caregivers will complete the BRIEF2. At 6 months, all baseline studies and a PSG will be repeated.
At baseline, demographic data will be collected, including information on residential address (for use in geocoding).
Conditions
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Down Syndrome
Obstructive Sleep Apnea
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Caregivers
Investigators
Outcome Assessors
Study Groups
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Oxygen plus supportive care (OXT)
Nocturnal oxygen therapy plus providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Group Type
ACTIVE_COMPARATOR
Oxygen
Intervention Type
DRUG
Active nocturnal oxygen concentrator
Supportive care (SC)
Providing patient with healthy sleep habits materials, healthy diet materials and nasal dilators.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Oxygen
Active nocturnal oxygen concentrator
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Ages 5.0 to 17.9 years at the time of screening
2. Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.
3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
4. Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
1. Oxygen saturation nadir \>92% and
2. Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG
3. Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
4. Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.
5. Willingness to comply with all study procedures and available for duration of study.
6. At baseline the participant attempts to perform the neuropsychological tests
2. Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour.
3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
4. Favorable response to oxygen therapy (allowing randomization) will be defined as follows:
1. Oxygen saturation nadir \>92% and
2. Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG
3. Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep.
4. Oxygen flow required does not exceed 3.0 LPM and does not exceed a FiO2 \> 40 %.
5. Willingness to comply with all study procedures and available for duration of study.
6. At baseline the participant attempts to perform the neuropsychological tests
Exclusion Criteria
1. Current CPAP use with documented compliance(\> 4 hrs/ night; \> 70% of nights).
2. Oxygen saturation \< 90% at rest during wakefulness.
3. Chronic daytime or nighttime use of supplemental oxygen.
4. Smoker in the child's bedroom.
5. Unrepaired congenital heart disease.
6. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
7. Unable to participate in a PSG.
8. Individuals who develop alveolar hypoventilation with oxygen as previously defined.
9. Other severe chronic diseases determined by their provider as making them poor study candidates.
10. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
11. Documented clinically significant untreated hypothyroidism
12. Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
2. Oxygen saturation \< 90% at rest during wakefulness.
3. Chronic daytime or nighttime use of supplemental oxygen.
4. Smoker in the child's bedroom.
5. Unrepaired congenital heart disease.
6. Moderate to severe pulmonary hypertension requiring treatment with oxygen and or pulmonary vasodilator.
7. Unable to participate in a PSG.
8. Individuals who develop alveolar hypoventilation with oxygen as previously defined.
9. Other severe chronic diseases determined by their provider as making them poor study candidates.
10. Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
11. Documented clinically significant untreated hypothyroidism
12. Children with adenotonsillar hypertrophy who are candidates for adenotonsillectomy and parents agree to the surgery.
Minimum Eligible Age
5 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
collaborator
Children's Hospital of Philadelphia
OTHER
Sponsor Role
collaborator
Rainbow Babies and Children's Hospital
OTHER
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
collaborator
Children's Hospital Los Angeles
OTHER
Sponsor Role
collaborator
Children's Hospital of The King's Daughters
OTHER
Sponsor Role
collaborator
Seattle Children's Hospital
OTHER
Sponsor Role
collaborator
University of Southern California
OTHER
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Susan Redline
Proffesor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Susan Redline
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Raouf Amin
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Site Status
RECRUITING
University of Michigan, Ann Arbor Hospital
Ann Arbor, Michigan, United States
Site Status
RECRUITING
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
RECRUITING
Rainbow Babies and Children's Hospital, Case Medical Center
Cleveland, Ohio, United States
Site Status
RECRUITING
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
East Virginia Medical Center
Norfolk, Virginia, United States
Site Status
RECRUITING
Seattle Children's Hospital
Seattle, Washington, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Jennison C and Turnbull GW. 2000. Group Sequential Methods with Applications to Clinical Trials. Boca Raton: Chapman & Hall/CRC.
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Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990 Jan-Feb;9(1-2):65-71; discussion 71-2. doi: 10.1002/sim.4780090113.
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Gould LA, and Shih WJ. 1992. Sample Size Re-Estimation Without Unblinding for Normally Distributed Outcomes with Unknown Variance. Communications in Statistics. Theory and Methods 21 (10): 2833-53.
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Friede T and Miller F. 2012. Blinded Continuous Monitoring of Nuisance Parameters in Clinical Trials. Applied Statistics 61 (4): 601-18.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023P000062
Identifier Type: -
Identifier Source: org_study_id
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