Trial Outcomes & Findings for Astral VAPS AutoEPAP Clinical Trial (NCT NCT02683772)

Results Overview

Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

Overnight, up to 8 hrs on nights 1 and 2

Results posted on

2019-07-26

Participant Flow

43 patients consented for this study. One patient did not meet criteria. 42 patients were randomized and began the first study PSG night. 3 patients were found to be ineligible due to I/E criteria not met. Site erroneously placed patient on ST mode for one of the PSG study nights. Thus, there were 38 patients that were analyzed.

Participant milestones

Participant milestones
Measure	iVAPS With AutoEPAP, Then iVAPS With Manual EPAP This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with AutoEPAP first, and the second night iVAPS with manual EPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.	iVAPS With Manual EPAP, Then iVAPS With AutoEPAP This is a crossover study. After randomization, patients in this arm will receive overnight PSG iVAPS with manual EPAP first, and the second night iVAPS with AutoEPAP. Therapy will be delivered using the clinical trial device, Astral. At least 4 hours of recording will be required.
Overall Study STARTED	15	23
Overall Study COMPLETED	15	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Astral VAPS AutoEPAP Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Total n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Age, Continuous	55.33 years STANDARD_DEVIATION 16.01 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	28 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	8 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
BMI	34.41 kg/m^2 STANDARD_DEVIATION 9.84 • n=5 Participants

PRIMARY outcome

Timeframe: Overnight, up to 8 hrs on nights 1 and 2

Population: This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.

Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP

Outcome measures

Outcome measures
Measure	iVAPS With AutoEPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.	iVAPS With Manual EPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Oxygen Desaturation Index 4% (ODI4%)	3.16 events per hour Standard Deviation 5.67	7.61 events per hour Standard Deviation 18.87

SECONDARY outcome

Timeframe: Overnight, up to 8 hrs on nights 1 and 2

To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)

Outcome measures

Outcome measures
Measure	iVAPS With AutoEPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.	iVAPS With Manual EPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Sleep Efficiency (%)	73.70 percentage of total sleep time Standard Deviation 16.41	73.89 percentage of total sleep time Standard Deviation 19.05

SECONDARY outcome

Timeframe: Overnight, up 8 hrs on night 1 and 2

Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.

To assess sleep-breathing parameters between groups using mean AHI (#events/hour)

Outcome measures

Outcome measures
Measure	iVAPS With AutoEPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.	iVAPS With Manual EPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Apnea Hypopnea Index (AHI)	4.71 events per hour Standard Deviation 5.55	7.84 events per hour Standard Deviation 15.39

SECONDARY outcome

Timeframe: Overnight, up 8 hrs on night 1 and 2

Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.

To assess Sleep-breathing parameters between groups using mean SpO2 (%)

Outcome measures

Outcome measures
Measure	iVAPS With AutoEPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.	iVAPS With Manual EPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Nadir Arterial Oxygen Saturation (SpO2)	94.24 percentage of oxygen saturation Standard Deviation 2.36	94.53 percentage of oxygen saturation Standard Deviation 2.78

SECONDARY outcome

Timeframe: Overnight, up 8 hrs on night 1 and 2

Population: Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.

To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)

Outcome measures

Outcome measures
Measure	iVAPS With AutoEPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.	iVAPS With Manual EPAP n=38 Participants This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS wtih AutoEPAP and iVAPS with manual EPAP intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.
Arterial Carbon Dioxide (PCO2)	45.49 milimeters of mercury Standard Deviation 6.62	45.38 milimeters of mercury Standard Deviation 7.17

Adverse Events

iVAPS With AutoEPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

iVAPS With Manual EPAP

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	iVAPS With AutoEPAP n=42 participants at risk This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients.	iVAPS With Manual EPAP n=42 participants at risk This is a crossover study. There were 42 patients randomized in total. 38 patients met the definition of evaluable. These 38 participated in both iVAPS with AutoEPAP and iVAPS with manual EPAP intervention assignments. Adverse Event data were collected for all 42 enrolled patients.
Respiratory, thoracic and mediastinal disorders Asthma exacerbation	0.00% 0/42 • Adverse Event data were collected for each patient enrolled into the study. AE data was collected from signing of Informed Consent Form until the patient's final completion date (PSG #2).	2.4% 1/42 • Number of events 1 • Adverse Event data were collected for each patient enrolled into the study. AE data was collected from signing of Informed Consent Form until the patient's final completion date (PSG #2).

Additional Information

Maureen Crocker, Manager Medical Affairs

ResMed

Phone: 8588366653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60