Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Cerebral Blood Flow and Neurocognition in Children With Obstructive Sleep Apnea
Verified date | May 2024 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | January 1, 2022 |
Est. primary completion date | January 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria (OSAS subjects): 1. 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. 2. Absence of neurologic, cardiovascular, pulmonary, or any other chronic illness with the exception of well-controlled asthma 3. No prior surgery on the nose, palate or oropharynx including an adenotonsillectomy 4. No current drug intake that may interfere with testing such as sedatives or stimulants 5. No prior treatment of sleep-disordered breathing 6. 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. 7. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria (OSAS Subjects) 1. Previous adenotonsillectomy 2. Previous use of CPAP 3. Craniofacial anomalies that can interfere with upper airway anatomy (e.g., Treacher-Collins syndrome) 4. Genetic syndromes (e.g., Trisomy 21, Prader-Willi) 5. Attention deficit hyperactivity disorder (ADHD) on medication 6. Developmental delay 7. Non-English speaking participants due to the nature of neurobehavioral testing Inclusion Criteria (Control subjects) 1. 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. 2. Absence of neurologic, cardiovascular, pulmonary, or any other chronic illness with the exception of well-controlled asthma 3. No prior surgery on the nose, palate or oropharynx including an adenotonsillectomy 4. No current drug intake that may interfere with testing such as sedatives or stimulants 5. No prior treatment of sleep-disordered breathing 6. Polysomnographic recording criteria: Normal control subjects must have an AHI = 1.5/hour. 7. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria (Control Subjects) 1. Previous adenotonsillectomy 2. Previous use of CPAP 3. Craniofacial anomalies that can interfere with upper airway anatomy (e.g., Treacher-Collins syndrome) 4. Genetic syndromes (e.g., Trisomy 21, Prader-Willi) 5. ADHD on medication 6. Developmental delay 7. Positive Pediatric Sleep Questionnaire 8. Non-English speaking participants due to the nature of neurobehavioral testing |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association Between CBF Regulation and Severity of OSAS | Children who completed baseline measurements were included. Correlation coefficients between the obstructive apnea hypopnea index and relative change of cerebral blood flow in children with obstructive sleep apnea and Controls are reported.
The Correlation Coefficient is calculated by dividing the Covariance of the apnea hypopnea index and CBF by the Standard deviation of the apnea hypopnea index and CBF. Units of the standard deviation of CBF= unit of CBF. So, in the correlation coefficient formula, units get canceled. The correlation coefficient does not have any units and can be positive or negative. In this case positive correlation coefficients signal better regulation of CBF. |
Up to 12 months | |
Other | Behavior Rating Inventory of Executive Function Global Executive Functioning T-score | Children who completed baseline measurements were included. One child in the obstructive sleep apnea arm did not complete the Behavior Rating Inventory of Executive Function testing.
Behavior Rating Inventory of Executive Function (global executive functioning T score) is reported between the 2 groups. Because this measures uses a T score, a score of 50 is considered average for the population. The scale is 0-100, with higher scores signaling executive functioning impairment. T-scores of 60-64 are in the mildly elevated range, and scores equal to or exceeding 65 are considered to be significantly elevated. The typical standard deviation (SD) observed is 10. |
baseline | |
Primary | Change in Cerebral Blood Flow (CBF) at Baseline Between Obstructive Sleep Apnea Syndrome (OSAS) and Controls | To determine whether children with OSAS have impaired blood flow regulation elicited by hypercapneic challenge compared to normal controls at baseline. | Baseline measurements, up to 24 hours | |
Secondary | Comparison of the Change in CBF From Baseline to Study Completion Between OSAS and Control Subjects | Only children who completed 2 or more repeated measurements were included in the analysis. The change in CBF measurements obtained at baseline when compared at 6 and 12 months after baseline for controls and after adenotonsillectomy for OSAS subjects. The slope of the change in CBF over time is reported: Delta CBF/Delta time, units= percentage over year. Minimum values are -100, maximum values +100, positive values mean better outcome.Cerebral blood flow were measured non-invasively while the child was breathing oxygen mixed with carbon dioxide. | Up to 12 Months |
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