Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04609618
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
Sponsor:
Y.A. Appscent Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Self-controlled, Feasibility Study to Evaluate Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.
Status:
COMPLETED
Status Verified Date:
2023-01
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:
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.
Detailed Description:
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. OSA lead to desaturation and often lead to an arousal.
Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .
Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.
The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). CPAP acts as a pneumatic splint that elevates and maintains a constant pressure along the upper airway during inspiration and expiration that prevents airway collapse. The major disadvantage of CPAP is the relatively low compliance.
Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake. Odorants transiently presented during sleep induced a respiratory rejection type response, this suggests that manipulating the respiratory system without waking is viable .
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?: