Trial Outcomes & Findings for TPAP for Comfort in OSA (NCT NCT06264128)
NCT ID: NCT06264128
Last Updated: 2024-12-11
Results Overview
Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O
COMPLETED
NA
150 participants
All tests conducted in a 20 minute time frame on awake supine patients.
2024-12-11
Participant Flow
Participant milestones
| Measure |
Sequence 1
Period 1: CPAP Period 2: TPAP
This was a trial in which the same participant underwent multiple testing in sequence and on the same session after being randomized only once (to CPAP or TPAP first). As such, only two sequences are present.
CPAP was initially administered at 9 cmH2O TPAP was initially reduced by 2+2 cmH2O
If the participant chose TPAP, the test was repeated as follows (see also below):
CPAP was administered at 13 cmH2O TPAP was reduced by 2+3 cmH2O
If the participant chose TPAP, testing ended.
If the participant, instead, had chosen CPAP at 9 cmH2O, the test was repeated as follows:
CPAP was administered at 9 cmH2O TPAP was reduced by 1+2 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 9 cmH2O, the test was repeated as follows:
CPAP was administered at 9 cmH2O TPAP was reduced by 1+1 cmH2O
Regardless, of the choice, the testing was repeated as follows:
CPAP was administered at 13 cmH2O TPAP was reduced by 2+3 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 13 cmH2O, testing was repeated as follows:
CPAP was administered at 13 cmH2O TPAP was reduced by 2+2 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 13 cmH2O, testing was repeated as follows:
CPAP was administered at 13 cmH2O TPAP was reduced by 1+2 cmH2O
Regardless of choices, testing ended after this.
|
Sequence 2
Period 1: TPAP Period 2: CPAP
This was a trial in which the same participant underwent multiple testing in sequence and on the same session after being randomized only once (to CPAP or TPAP first). As such, only two sequences are present.
TPAP was initially reduced by 2+2 cmH2O CPAP was initially administered at 9 cmH2O
If the participant chose TPAP, the test was repeated as follows (see also below):
TPAP was reduced by 2+3 cmH2O CPAP was administered at 13 cmH2O
If the participant chose TPAP, testing ended.
If the participant, instead, had chosen CPAP at 9 cmH2O, the test was repeated as follows:
TPAP was reduced by 1+2 cmH2O CPAP was administered at 9 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 9 cmH2O, the test was repeated as follows:
TPAP was reduced by 1+1 cmH2O CPAP was administered at 9 cmH2O
Regardless, of the choice, the testing was repeated as follows:
TPAP was reduced by 2+3 cmH2O CPAP was administered at 13 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 13 cmH2O, testing was repeated as follows:
TPAP was reduced by 2+2 cmH2O CPAP was administered at 13 cmH2O
If the participant chose TPAP, testing ended.
If the participant chose CPAP at 13 cmH2O, testing was repeated as follows:
TPAP was reduced by 1+2 cmH2O CPAP was administered at 13 cmH2O
Regardless of choices, testing ended after this.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
74
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TPAP for Comfort in OSA
Baseline characteristics by cohort
| Measure |
Overall Group
n=150 Participants
All participants in the study (who crossovered from one treatment arm to the other)
|
|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome refers to % of participants who preferred TPAP over CPAP
Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=150 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O
|
69.3 percentage of total participants
Interval 61.0 to 77.0
|
PRIMARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome refers to % of participants who preferred TPAP over CPAP
Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=150 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O
|
84 percentage of total participants
Interval 77.0 to 89.0
|
SECONDARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome data refers to participants (N=21) who preferred TPAP (with a 1+2 cmH2O drop) over CPAP at 9 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 9 cmH2O and TPAP with a 2+2 cmH2O, independent of sequence. I.e., 46 participants found CPAP more comfortable than TPAP with 2+2 cmH2O drop, so testing continued with those individuals, of whom, eventually, 21 chose TPAP with 1+2 cmH2O drop.
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=46 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
|
45.6 percentage of total participants
|
SECONDARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome data refers to participants (N=14) who preferred TPAP (with a 1+1 cmH2O drop) over CPAP at 9 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 9 cmH2O and TPAP with a 2+2 cmH2O or with at 1+2 cmH2O drop, independent of sequence. I.e., only 25 participants found CPAP more comfortable than TPAP at any drop, so testing continued with those individuals, of whom, eventually, 14 chose TPAP with 1+1 cmH2O drop.
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=25 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O
|
56 percentage of total participants
|
SECONDARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome data refers to participants (N=11) who preferred TPAP (with a 2+2 cmH2O drop) over CPAP at 13 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 13 cmH2O and TPAP with a 2+3 cmH2O, independent of sequence. I.e., only 24 participants found CPAP more comfortable than TPAP with 2+3 cmH2O drop, so testing continued with those individuals, of whom, eventually, 11 chose TPAP with 2+2 cmH2O drop.
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=24 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O
|
45.8 percentage of total participants
|
SECONDARY outcome
Timeframe: All tests conducted in a 20 minute time frame on awake supine patients.Population: The outcome data refers to participants (N=5) who preferred TPAP (with a 1+2 cmH2O drop) over CPAP at 13 cmH2O.Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 13 cmH2O and TPAP with a 2+3 cmH2O or with at 2+2 cmH2O drop, independent of sequence. I.e., only 13 participants found CPAP more comfortable than TPAP at any drop, so testing continued with those individuals, of whom, eventually, 5 chose TPAP with 1+2 cmH2O drop
Outcome measures
| Measure |
CPAP vs. TPAP (Baseline Pressure: 9 cmH2O )
n=13 Participants
CPAP at 9 cmH2O TPAP at 9 cmH2O with sequential comfort drops of 2+2 cmH2O
|
|---|---|
|
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
|
38.5 percentage of total participants
|
Adverse Events
TPAP
CPAP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place