N/A
N=34
Cerebral Blood Flow and Childhood Obstructive Sleep Apnea
Obstructive Sleep Apnea Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02995837 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Cerebral Blood Flow (CBF) at Baseline Between Obstructive Sleep Apnea Syndrome (OSAS) and Controls — 184; 209 percentage of change from baseline
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sleep Study (Other); Neurocognitive Testing (Other); CBF During Wakefulness (Other); CBF During Sleep (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cerebral Blood Flow (CBF) at Baseline Between Obstructive Sleep Apnea Syndrome (OSAS) and Controls |
184; 209 | — |
| SECONDARY Comparison of the Change in CBF From Baseline to Study Completion Between OSAS and Control Subjects |
0.013; -0.083 | — |
Summary
Obstructive sleep apnea syndrome (OSAS) causes hypoxemia and hypercapnia, which may impair cerebral blood flow and cause deficits in behavior. This is a case-control study designed to investigate cerebral blood flow and neurocognitive function in children with OSAS when compared to these findings from normal children. The study hypothesis is that children with OSAS have an impaired cerebral blood flow during wakefulness and sleep compared to normal controls, and that the degree of this impairment correlates with neurocognitive function.
Eligibility Criteria
Inclusion Criteria (OSAS subjects):
- Age between 6 years and 12 years. The lower limit criterion was selected to include children who can understand and cooperate with testing. The upper limit criterion was selected to avoid overlap with the adult presentation of OSAS.
- Absence of neurologic, cardiovascular, pulmonary, or any other chronic illness with the exception of well-controlled asthma
- No prior surgery on the nose, palate or oropharynx including an adenotonsillectomy
- No current drug intake that may interfere with testing such as sedatives or stimulants
- No prior treatment of sleep-disordered breathing
- Polysomnographic recording criteria: subjects with OSAS must have an obstructive apnea hypopnea index (AHI) ≥ 5/hour and be a candidate for clinically-indicated surgical treatment.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria (OSAS Subjects)
- Previous adenotonsillectomy
- Previous use of CPAP
- Craniofacial anomalies that can interfere with upper airway anatomy (e.g., Treacher-Collins syndrome)
- Genetic syndromes (e.g., Trisomy 21, Prader-Willi)
- Attention deficit hyperactivity disorder (ADHD) on medication
- Developmental delay
- Non-English speaking participants due to the nature of neurobehavioral testing
Inclusion Criteria (Control subjects)
- Age between 6 years and 12 years. The lower limit criterion was selected to include children who can understand and cooperate with testing. The upper limit criterion was selected to avoid overlap with the adult presentation of OSAS.
- Absence of neurologic, cardiovascular, pulmonary, or any other chronic illness with the exception of well-controlled asthma
- No prior surgery on the nose, palate or oropharynx including an adenotonsillectomy
- No current drug intake that may interfere with testing such as sedatives or stimulants
- No prior treatment of sleep-disordered breathing
- Polysomnographic recording criteria: Normal control subjects must have an AHI ≤ 1.5/hour.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria (Control Subjects)
- Previous adenotonsillectomy
- Previous use of CPAP
- Craniofacial anomalies that can interfere with upper airway anatomy (e.g., Treacher-Collins syndrome)
- Genetic syndromes (e.g., Trisomy 21, Prader-Willi)
- ADHD on medication
- Developmental delay
- Positive Pediatric Sleep Questionnaire
- Non-English speaking participants due to the nature of neurobehavioral testing
Data sourced from ClinicalTrials.gov (NCT02995837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.