Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05052216
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2021-09-21
Brief Title:
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-09-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Obstructive sleep apnea OSA occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep Pediatric OSA can be especially concerning and can have long-term effects Researchers want to see how a monitoring device called near-infrared spectroscopy NIRS compares with the traditional techniques used in children s sleep studies
Objective
To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable point-of-care biosensor
Eligibility
Children aged 3-12 who have OSA and plan to receive treatment OSA group or who do not have OSA NORM group
Design
Participants will be screened with a review of their medical records If they have taken part in other NIH studies that data will be reviewed as well
Participants in the NORM group will have 1 overnight study visit Those in the OSA group will have 2 overnight study visits
Participants will do an overnight sleep study They will have a physical exam and medical history They will have a sleep study electroencephalography EEG For this electrodes will be placed on their head They will wear a gauze cap to keep the electrodes in place Two NIRS probes made of a soft silicon will be placed on their forehead and arm They will follow their normal bedtime routine Their parent will stay overnight
The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea They will repeat the sleep study
Obstructive sleep apnea OSA occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep Pediatric OSA can be especially concerning and can have long-term effects Researchers want to see how a monitoring device called near-infrared spectroscopy NIRS compares with the traditional techniques used in children s sleep studies
Objective
To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable point-of-care biosensor
Eligibility
Children aged 3-12 who have OSA and plan to receive treatment OSA group or who do not have OSA NORM group
Design
Participants will be screened with a review of their medical records If they have taken part in other NIH studies that data will be reviewed as well
Participants in the NORM group will have 1 overnight study visit Those in the OSA group will have 2 overnight study visits
Participants will do an overnight sleep study They will have a physical exam and medical history They will have a sleep study electroencephalography EEG For this electrodes will be placed on their head They will wear a gauze cap to keep the electrodes in place Two NIRS probes made of a soft silicon will be placed on their forehead and arm They will follow their normal bedtime routine Their parent will stay overnight
The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea They will repeat the sleep study
Detailed Description:
Study Description
This observational study will assess the sensitivity of near-infrared spectroscopy NIRS to hemodynamic events caused by pediatric obstructive sleep apnea POSA NIRS can provide a direct examination of brain oxygen saturation that traditional sleep study measurements are not able to capture and may be capable of better explaining health outcomes related to this disease The purpose of this study is to characterize a wearable point-of-care NIRS device that measures multiple physiological signals with a focus on cerebral and peripheral oxygenation in children with obstructive sleep apnea and to establish the relationship between traditionally measured parameters during sleep studies polysomnography and NIRS technologies This study will be conducted in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center Care will not be altered for any patients and this study will be purely observational with no significant risk added to any patient We hypothesize that changes in NIRS signals of cerebral and peripheral tissue oxygenation due to apnea events will correlate with respiratory flow and oxygen saturation changes measured with PSG
Objectives
Primary Objective Characterize cerebral oxygen saturation and peripheral tissue oxygen saturation during both normal sleep and sleep apnea events in children with respect to traditional polysomnography parameters
Exploratory Objective 1 Characterize cerebral and peripheral tissue oxygen saturation before and after POSA treatment with respect to traditional polysomnography parameters
Exploratory Objective 2 Characterize the dynamics of hemoglobin concentrations and tissue oxygenation during different sleep stages
Exploratory Objective 3 Compare dynamics of cerebral and peripheral tissue oxygen saturation during apneic events in sleep state to a breath hold while subject is awake
Endpoints
Primary Endpoint cerebral oxygen saturation ScO2 peripheral tissue oxygen saturation StO2 pulsatile oxygen saturation SpO2 respiratory flow
Exploratory Endpoint 1 baseline and post-treatment ScO2 StO2 SpO2 AHI respiratory flow
Exploratory Endpoint 2 baseline and post-treatment delta hemoglobin delta deoxyhemoglobin cerebral oxygen saturation
Exploratory Endpoint 3 ScO2 StO2 during apnea and breath hold
This observational study will assess the sensitivity of near-infrared spectroscopy NIRS to hemodynamic events caused by pediatric obstructive sleep apnea POSA NIRS can provide a direct examination of brain oxygen saturation that traditional sleep study measurements are not able to capture and may be capable of better explaining health outcomes related to this disease The purpose of this study is to characterize a wearable point-of-care NIRS device that measures multiple physiological signals with a focus on cerebral and peripheral oxygenation in children with obstructive sleep apnea and to establish the relationship between traditionally measured parameters during sleep studies polysomnography and NIRS technologies This study will be conducted in collaboration with the Sleep and Neurodevelopment Service at the NIH Clinical Center Care will not be altered for any patients and this study will be purely observational with no significant risk added to any patient We hypothesize that changes in NIRS signals of cerebral and peripheral tissue oxygenation due to apnea events will correlate with respiratory flow and oxygen saturation changes measured with PSG
Objectives
Primary Objective Characterize cerebral oxygen saturation and peripheral tissue oxygen saturation during both normal sleep and sleep apnea events in children with respect to traditional polysomnography parameters
Exploratory Objective 1 Characterize cerebral and peripheral tissue oxygen saturation before and after POSA treatment with respect to traditional polysomnography parameters
Exploratory Objective 2 Characterize the dynamics of hemoglobin concentrations and tissue oxygenation during different sleep stages
Exploratory Objective 3 Compare dynamics of cerebral and peripheral tissue oxygen saturation during apneic events in sleep state to a breath hold while subject is awake
Endpoints
Primary Endpoint cerebral oxygen saturation ScO2 peripheral tissue oxygen saturation StO2 pulsatile oxygen saturation SpO2 respiratory flow
Exploratory Endpoint 1 baseline and post-treatment ScO2 StO2 SpO2 AHI respiratory flow
Exploratory Endpoint 2 baseline and post-treatment delta hemoglobin delta deoxyhemoglobin cerebral oxygen saturation
Exploratory Endpoint 3 ScO2 StO2 during apnea and breath hold
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000224-CH | None | None | None |