Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873024
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2021-04-12
Brief Title:
Prevention of Airway Obstruction Events
Sponsor:
NovaResp Technologies Inc
Organization:
NovaResp Technologies Inc
Study Overview
Official Title:
Real-time Prediction and Prevention of Apnea Events on PAP Machines in an Interventional Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The standard for treatment for people suffering from obstructive sleep apnea OSA syndrome involves the use of Continuous or Automatic Positive Airway Pressure CPAP APAP machines which work by delivering air via tubing and mask to a patient at pressures of up to 20cmH2O This increased pressure is meant to stabilize the airway to reduce obstruction events APAP machines are generally more effective and more comfortable for patients than CPAP machines because these devices automatically adjust pressure to treat an apnea However this treatment is reactive and often ineffective since the necessary pressure is applied seconds after breathing has already stopped The results of a previous study performed showed strong indications for predicting an apnea before it occurs using measurements collected by existing sensors of the CPAP and APAP machines If apnea events can be predicted before they occur the air pressure required to treat them could be supplied ahead of time preventing the apnea from occurring
The hypothesis to be tested is whether obstructive sleep apnea events can be prevented by predicting their onset ahead of time and adjusting the airway pressure accordingly
The hypothesis to be tested is whether obstructive sleep apnea events can be prevented by predicting their onset ahead of time and adjusting the airway pressure accordingly
Detailed Description:
Patients recruited for the study will undergo two different PAP therapy treatments during sleep a control treatment and an intervention treatment Both types of treatment will be delivered using a positive airway pressure PAP device with an Investigational Testing Authorization ITA from Health Canada HC This medical device consists of a commercially available PAP device which has been integrated with a feature to communicate with a computer hosting the predictive software via USB Using signals received from the PAP device the software can predict incoming apneas and direct the PAP machine to increase pressure for a short period of time This study has been designed as a single-blind randomised crossover study in which recruited patients who suffer from Obstructive Sleep Apnea OSA will undergo at least two sleep studies During a sleep study the patient will spend a night of sleep at the sleep clinic Sleep Disorders Clinic QEII Abbie J Lane Memorial Building and receive one of two PAP therapy treatments For the control treatment the PAP device will deliver standard PAP therapy treatment to the patient For the intervention treatment the PAP device will deliver the standard PAP therapy treatment in addition to intervention when an apnea is predicted All recruited participants will undergo at least two study nights and receive both treatments at least once For all study night standard Polysomnography PSG measurements will also be acquired breathing rate brain waves movement blood rate oxygen levels etc Participants will not be told what therapies are being used for each night and the device used will be concealed from their view After each night participants will be asked to fill out a SatisfactionAdherence questionnaire
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