Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547463
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Nasal Airflow on Sleep in Tracheotomized Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NASA
Brief Summary:
The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain which induces cerebral activation in functional brain areas and is associated with better cognitive performance compared to oral breathing Consequently the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity Besides the loss of olfaction the abolition of nasal ventilation could affect brain activity and sleep
The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality notably with a greater proportion of time spent in REM sleep
The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality notably with a greater proportion of time spent in REM sleep
Detailed Description:
The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation The first consequence is the loss of olfactory function This function is quickly recovered when nasal ventilation is made possible However the abolition of nasal ventilation may have consequences beyond the loss of olfaction The abolition of nasal ventilation in intubated rats inhibits these rhythmic oscillations which can be restored by nasal sprays In humans nasal ventilation induces cerebral activity in functional brain areas and is associated with better cognitive performance compared to oral ventilation In a model of intubated and ventilated rats it has been shown that nasal sprays synchronized with the ventilator reduce hippocampal lesions compared to animals ventilated with an endotracheal tube without nasal sprays Finally in patients intubated with an endotracheal tube for toxic comas the same nasal spray system restored brain activity and neural connectivity
The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation Patients will be investigated by a full polysomnography during two consecutive nights with and without nasal airflow on the top of invasive mechanical ventilation the two nights being randomized
The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation Patients will be investigated by a full polysomnography during two consecutive nights with and without nasal airflow on the top of invasive mechanical ventilation the two nights being randomized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None