Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-03
Brief Title:
TheraPAP Adherence Crossover Study
Sponsor:
SleepRes Inc
Organization:
SleepRes Inc
Study Overview
Official Title:
A Prospective Randomized Crossover Study of Therapy Adherence With TheraPAP Compared to Automatic Adjusting Positive Airway Pressure APAP for the Treatment of 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:
TheraPAP is a novel therapy approach being developed by SleepRes LLC for the treatment of obstructive sleep apnea OSA This algorithm has been integrated into the Sefam SBox CPAP continuous positive airway pressure device and both standard CPAPAPAP auto-titrated PAP as well as TheraPAP can be delivered TheraPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until some point in late expiration In this randomized crossover study the comparative adherence to therapy between TheraPAP and APAP will be compared Each therapy will be used by the patient for six-week periods with randomly assigned order and the usage during each arm will be compared
Detailed Description:
The TheraPAP Adherence Study is a randomized crossover study in treatment naive participants with OSA in which the adherence to therapy will be compared between TheraPAP and standard APAP Because all participants will breathe on both therapy types and those therapy types are individually unique in feel blinding is not possible Participants will be chosen from a pool of patients who are PAP-naïve and who have received either a PSG in-lab polysomnogram split-night study in-lab PSG and pressure titration or home sleep study HST within the previous 3 months
Upon signing an informed consent participants will be randomly assigned to start on either the TheraPAP or APAP arms when they arrive at the office to pick up their Sefam SBox with TheraPAP algorithms integrated Each participant will then be given their new equipment and will be trained in proper use for both arms of the study so that they will not need to appear at the office again until the study is completed In both the APAP and TheraPAP arms participants will have their therapy set to 5-20 cmH2O for three nights The pressure range will then be narrowed to 2 cmH2O around their 95 pressure level as assessed during the third night This same pressure range will be used during the second arm for each patient
Within the TheraPAP arm participants will be set to a double Comfort Setting drop according to the following table This drop schedule will be implemented even while the TheraPAP device is operating with automatic pressure adjustment
Pset Drop 1 Drop 2 50 - 59 0 0 60 - 69 1 0 70 - 79 2 0 80 - 89 2 1 90 - 99 2 2 100 - 200 2 3
Participants will use their starting therapy nightly at home for 6 weeks after which time they will undergo a washout period of 1 week where no therapy will be used Following the washout period they will initiate another 6-week usage with the second therapy Afterward they will return to the office to receive their permanent equipment Phone calls as reminders to end the first arm start the washout period then to start the second arm will be made
Immediately after both arms of the study are completed the following will occur
Eligibility criteria will be reviewed and confirmed
Participants will be asked to respond to the following ESS Epworth Sleepiness Scale FOSQ Functional Outcomes of Sleep Questionnaire
During the home use period subjects will be called at the following time points during each arm of the study At each time point adverse events and compliance with the device will be assessed Subjects using the device less than an average of 5 hours per night during the first week will be contacted on a more regular basis weekly until 5 hour per night use is achieved to address any problems and encourage use If patients discontinue use of the device during the home use period they will still be encouraged to return for all testing per protocol If a patient refuses to come in for further testing they will be considered a lost to follow up and excluded from efficacy analysis
Upon signing an informed consent participants will be randomly assigned to start on either the TheraPAP or APAP arms when they arrive at the office to pick up their Sefam SBox with TheraPAP algorithms integrated Each participant will then be given their new equipment and will be trained in proper use for both arms of the study so that they will not need to appear at the office again until the study is completed In both the APAP and TheraPAP arms participants will have their therapy set to 5-20 cmH2O for three nights The pressure range will then be narrowed to 2 cmH2O around their 95 pressure level as assessed during the third night This same pressure range will be used during the second arm for each patient
Within the TheraPAP arm participants will be set to a double Comfort Setting drop according to the following table This drop schedule will be implemented even while the TheraPAP device is operating with automatic pressure adjustment
Pset Drop 1 Drop 2 50 - 59 0 0 60 - 69 1 0 70 - 79 2 0 80 - 89 2 1 90 - 99 2 2 100 - 200 2 3
Participants will use their starting therapy nightly at home for 6 weeks after which time they will undergo a washout period of 1 week where no therapy will be used Following the washout period they will initiate another 6-week usage with the second therapy Afterward they will return to the office to receive their permanent equipment Phone calls as reminders to end the first arm start the washout period then to start the second arm will be made
Immediately after both arms of the study are completed the following will occur
Eligibility criteria will be reviewed and confirmed
Participants will be asked to respond to the following ESS Epworth Sleepiness Scale FOSQ Functional Outcomes of Sleep Questionnaire
During the home use period subjects will be called at the following time points during each arm of the study At each time point adverse events and compliance with the device will be assessed Subjects using the device less than an average of 5 hours per night during the first week will be contacted on a more regular basis weekly until 5 hour per night use is achieved to address any problems and encourage use If patients discontinue use of the device during the home use period they will still be encouraged to return for all testing per protocol If a patient refuses to come in for further testing they will be considered a lost to follow up and excluded from efficacy analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None