Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407999
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Pressure Relief Algorithm Eval
Sponsor:
SleepRes Inc
Organization:
SleepRes Inc
Study Overview
Official Title:
A Prospective Randomized Crossover Study on the Effect of Pressure Relief Algorithms PRA on Therapy Pressure in APAP Therapy for Obstructive Sleep Apnea OSA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 PRA Effect on APAP Therapy Pressure Study is a randomized controlled crossover study in PAP-adherent participants with OSA Pre-screening is conducted to establish potential eligibility based on regular usage of 4 hoursnight on patients who use an APAP device with a PRA mode Participants would then be recruited as described below For those who sign an informed consent they will be instructed to use the device for the next 8 days with the PRA turned on for four consecutive nights and off for four consecutive nights but in random orientation To make sure that the device is not limited to APAP range when adjusting to respond to PRA the upper limit will be changed to 20 cmH2O during the study Additionally only patients who have a current P95 of 8 cmH2O or greater will be eligible so that the maximum PRA setting of 3 cmH2O can be used
Detailed Description:
The first phase of recruiting for the PRA Effect on APAP Therapy Pressure Study will be done during a single phone contact following an email recruitment During this call participants will be explained the study along with risks and benefits and evaluated for inclusion and exclusion criteria If the participant is eligible to enter the study they will be sent an electronic Informed Consent Form to sign Once the form is signed and verified the study can then start that evening after the participants device has been set for the study
During both arms of the study every aspect of operation of the APAP devices will be the same as those the patient normally uses except for the following three things
APAP upper range limit will be set to 20 cmH2O
PRA or 3 cmH2O will be either on or off
Participants cannot use a V-Com device Participants will randomly be assigned to start with or without PRA Once the settings are remotely assigned to the device the patient will sleep on these settings for four nights ideally consecutively
After four nights the PRA setting will be remotely switched to the 2nd arm setting on or off and median and P95 pressure Usage AHI and Leak averaged over those four nights will be downloaded The participant will then use the device with the new settings for an additional four nights hopefully also sequentially
Following the 2nd group of four nights median and P95 pressure Usage AHI and Leak averaged over those four nights will be downloaded the participant will be informed that their involvement in the study is complete and the device will be remotely set back to the settings it had prior to the study Participants will then receive the compensation credit
During both arms of the study every aspect of operation of the APAP devices will be the same as those the patient normally uses except for the following three things
APAP upper range limit will be set to 20 cmH2O
PRA or 3 cmH2O will be either on or off
Participants cannot use a V-Com device Participants will randomly be assigned to start with or without PRA Once the settings are remotely assigned to the device the patient will sleep on these settings for four nights ideally consecutively
After four nights the PRA setting will be remotely switched to the 2nd arm setting on or off and median and P95 pressure Usage AHI and Leak averaged over those four nights will be downloaded The participant will then use the device with the new settings for an additional four nights hopefully also sequentially
Following the 2nd group of four nights median and P95 pressure Usage AHI and Leak averaged over those four nights will be downloaded the participant will be informed that their involvement in the study is complete and the device will be remotely set back to the settings it had prior to the study Participants will then receive the compensation credit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None