Trial Outcomes & Findings for TheraPAP Equivalence Crossover Study (NCT NCT06238362)

NCT ID: NCT06238362

Last Updated: 2024-11-29

Results Overview

Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index \< 5 events/h.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: During overnight procedure, on average 3.5 hours for each intervention
• Results posted on: 2024-11-29

Participant Flow

Participant milestones

Measure	Sequence 1: CPAP First TPAP Second CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow	Sequence 2: TPAP First CPAP Second CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow
Overall Study STARTED	28	22
Overall Study COMPLETED	26	22
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Sequence 1: CPAP First TPAP Second CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow	Sequence 2: TPAP First CPAP Second CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow
Overall Study Insufficient total sleep time	1	0
Overall Study Inadequate signal quality	1	0

Baseline Characteristics

TheraPAP Equivalence Crossover Study

Baseline characteristics by cohort

Measure	Overall Group n=50 Participants The study was a crossover trial of two treatment administered over the same night.
Age, Continuous	50 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
P90/P95	10.6 cmH2O STANDARD_DEVIATION 2.5 • n=5 Participants

PRIMARY outcome

Timeframe: During overnight procedure, on average 3.5 hours for each intervention

Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index < 5 events/h.

Outcome measures

Measure	TPAP - Experimental Therapy n=48 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=48 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
Apnea/Hypopnea Index	2.9 events/h Standard Deviation 4.1	3.2 events/h Standard Deviation 3.9

SECONDARY outcome

Timeframe: During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention

Population: Some people did not have REM sleep, hence the reduced participant sample

Scored as number of respiratory events per hour of sleep spent in rapid eye movement stage. The device is generally considered efficacious with an apnea-hypopnea index in REM < 5 events/h, however it has to be noted that obstructive sleep apnea during REM sleep is more difficult to treat.

Outcome measures

Measure	TPAP - Experimental Therapy n=43 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=43 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
REM Apnea/Hypopnea Index (AHI)	4.3 events/h Standard Deviation 5.1	6 events/h Standard Deviation 6.8

SECONDARY outcome

Timeframe: During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention

Population: Some people did not sleep in supine position, thus the participant sample is reduced

Assessment of AHI (apnea hypopnea index) during supine sleep. The device is generally considered efficacious if supine AHI is below 5 events/h, however it has to be noted that obstructive sleep apnea in supine position is more difficult to treat.

Outcome measures

Measure	TPAP - Experimental Therapy n=40 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=40 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
Supine AHI	4.9 events/h Standard Deviation 7.5	5.4 events/h Standard Deviation 6.9

SECONDARY outcome

Timeframe: During overnight procedure

Population: With some machine, it was not possible to determine the leak with precision, hence the reduced participant sample

Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak

Outcome measures

Measure	TPAP - Experimental Therapy n=45 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=45 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
Unintentional Patient Circuit Leak	2.8 L/min Standard Deviation 3.6	5.1 L/min Standard Deviation 4.3

SECONDARY outcome

Timeframe: During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention

Scored as number of respiratory events per hour of sleep spent in non-rapid eye movement stage (NREM). The device is generally considered efficacious with an apnea-hypopnea index in NREM < 5 events/h.

Outcome measures

Measure	TPAP - Experimental Therapy n=48 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=48 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
NREM Apnea/Hypopnea Index (AHI)	2.3 events/h Standard Deviation 4.4	2.2 events/h Standard Deviation 3.7

SECONDARY outcome

Timeframe: During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention

Population: Some people did not sleep in lateral position, thus the participant sample is reduced

Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h

Outcome measures

Measure	TPAP - Experimental Therapy n=39 Participants Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=37 Participants Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
Lateral AHI	2.4 events/h Standard Deviation 5.4	3 events/h Standard Deviation 5.8

Adverse Events

TPAP - Experimental Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

CPAP - Traditional OSA Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TPAP - Experimental Therapy n=50 participants at risk Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration. TPAP: Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP	CPAP - Traditional OSA Therapy n=50 participants at risk Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea.
Nervous system disorders Insufficient sleep	2.0% 1/50 • Number of events 1 • 1 night (half night for each treatment)	0.00% 0/50 • 1 night (half night for each treatment)

Additional Information

Bernard Hete

SleepRes

Phone: +1 615-921-2406

Email: bhete@sleepres.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place