Cerebral Blood Flow and Childhood Obstructive Sleep Apnea
NCT02995837 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47
Last updated 2024-07-09
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.
Conditions
- Obstructive Sleep Apnea Syndrome
Interventions
- OTHER
-
Sleep Study
Overnight, video-recorded sleep study will be performed in a dedicated pediatric sleep lab. Sleep architecture, apneas and hypopneas, arterial oxygen saturation and end-tidal carbon dioxide tension will be evaluated during the sleep study. Safety measures including arterial oxygen saturation using pulse oximetry, EEG and EKG will be continuously monitored during the study.
- OTHER
-
Neurocognitive Testing
Cognitive and behavioral measures including intelligence, attention, working memory, and processing speed will be assessed by a trained psychologist.
- OTHER
-
CBF During Wakefulness
Cerebral blood flow (CBF) will be measure using Diffuse optical and correlation spectroscopy (DOS/DCS), a non-significant risk device used to collect data for this study but not being tested as part of the protocol. Light sources and detectors which are embedded in a rubber pad will be attached to the subject's head in order to record right and left hemispheric cerebral blood flow, total hemoglobin concentration and tissue oxygen saturation. Measurements will be continuously recorded during the study and averaged for purposes of statistical analysis. With DOS/DCS in place, ventilatory response to hypercapnia will be determined using the rebreathing technique, a standard clinical test. While CBF is being measured, subjects will wear nose clips and sit comfortably breathing through a mouthpiece while the level of carbon dioxide is adjusted over a 3-4 minute period. Oxygen and carbon dioxide levels will be carefully monitored throughout the testing.
- OTHER
-
CBF During Sleep
This is the same as the CBF testing during wakefulness/daytime except that it will be done during a sleep study performed with a continuous positive airway pressure (CPAP) mask not nose clips and a mouthpiece. With DOS/DCS in place, ventilatory response to hypercapnia will be determined using the rebreathing technique. While CBF is being measured, OSAS subjects will receive an individualized positive pressure aimed at treating obstructive sleep apnea and controls will receive a standard pressure. End-tidal carbon dioxide will be measured via a port in the mask. A constant flow of carbon dioxide will be introduced to the circuit, a slowly adjusted until the patient arouses or for a maximum of 3 minutes, whichever occurs first. One trial will be attempted in each sleep stage (slow-wave sleep and rapid-eye-movement) with a minimum of 15 minute of breathing room air between challenges. Oxygen and carbon dioxide levels will be carefully monitored throughout the testing.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Ignacio E. Tapia, MD, MS · Children's Hospital of Philadelphia
Eligibility
- Min Age
- 6 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2022-01-01
- Completion
- 2022-01-01
Countries
- United States
Study Locations
More Related Trials
-
The Natural History and Outcome of Sleep Disordered Breathing in Children
NCT02043353 ·Status: UNKNOWN
-
Real Life Pediatric Obstructive Sleep Apnea
NCT03950466 ·Status: UNKNOWN
-
Establishment of a Diagnosis and Treatment System for Information Processing Damage in Children With OSAHS
NCT04080089 ·Status: UNKNOWN
-
Airway Ultrasound Prediction and Correlation
NCT03313947 ·Status: WITHDRAWN ·Phase: NA
-
Inflammatory Markers in Infants With Obstructive Sleep Apnea
NCT01058590 ·Status: UNKNOWN
-
Investigating the Neuropathology of Obstructive Sleep Apnoea
NCT02967536 ·Status: COMPLETED
-
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
NCT01808508 ·Status: COMPLETED ·Phase: NA
-
Prevalence of Sleep-Disordered Breathing in Children
NCT00022789 ·Status: COMPLETED
-
Clinical Predictors of Pediatric OSAHS
NCT02627937 ·Status: UNKNOWN
-
Cerebrovascular Reactivity in Obstructive Sleep Apnea (OSA) Subjects
NCT01133717 ·Status: UNKNOWN
-
Prevalence of Sleep Apnoea in Adolescents
NCT03895775 ·Status: RECRUITING
-
Investigation of Sleep Quality and Prevalence of Sleep-disordered Breathing in Children and Young People With Epilepsy
NCT03103841 ·Status: COMPLETED
-
Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?
NCT02930538 ·Status: WITHDRAWN
-
The Effect of Obstructive Sleep Apnea and Its Treatment on Decision Making
NCT03262519 ·Status: UNKNOWN
-
Evaluating the Relationship Between Sleep-Disordered Breathing and Daytime Alertness
NCT00393913 ·Status: COMPLETED
-
Central Apnoea Monitor Study
NCT06093347 ·Status: WITHDRAWN
-
The Effects of CPAP Withdrawal on Cerebral Vascular Reactivity and Brain Oxygenation in OSA
NCT02493673 ·Status: COMPLETED ·Phase: NA
-
Home Apnea Testing in CHildren Trial
NCT05382754 ·Status: RECRUITING ·Phase: NA
-
Neurocognitive Function After Therapy of OSAS
NCT02505620 ·Status: COMPLETED
-
Video-respiratory Polygraphy in Children
NCT06287333 ·Status: NOT_YET_RECRUITING
-
Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea
NCT04321083 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Effects of Exercise Training on Cognitive Performance and Sympathetic Activity in Obstructive Sleep Apnea
NCT02289625 ·Status: UNKNOWN ·Phase: NA
-
Sleep Apnea in Sickle Cell Disease
NCT03753854 ·Status: TERMINATED ·Phase: NA
-
Obesity and Obstructive Sleep Apnea (OSA) in Children
NCT01135147 ·Status: UNKNOWN ·Phase: NA
-
Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome
NCT05147649 ·Status: RECRUITING ·Phase: NA