Trial Outcomes & Findings for Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT01601977)

Results Overview

transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

10 participants

Primary outcome timeframe

baseline, 6 week assessment

Results posted on

2016-08-18

Participant Flow

Patients approached in ventilation clinic and assessed for trial participation. Patients were recruited and scheduled for trial initiation. Once 10 patients completed the study protocol the remaining recruited patients did not start the assessment period.

Participant milestones

Participant milestones
Measure	All Study Participants Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants Single arm crossover nonrandomised study
Age, Continuous	63 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 6 week assessment

transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Control of Nocturnal Hypoventilation	6.5 kPa Standard Deviation 1.6	6.7 kPa Standard Deviation 1.4

SECONDARY outcome

Timeframe: 2 weeks

Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Health Related Quality of Life	60 units on a scale Standard Deviation 15	59 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: 6 weeks

Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Health Related Quality of Life	61 units on a scale Standard Deviation 17	59 units on a scale Standard Deviation 16

SECONDARY outcome

Timeframe: baseline, 6 weeks

Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Total Sleep Time	330 minutes Standard Deviation 72	306 minutes Standard Deviation 72

SECONDARY outcome

Timeframe: 2 weeks

mean tcCO2

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Control of Nocturnal Hypoventilation	6.4 kPa Standard Deviation 1.7	6.5 kPa Standard Deviation 1.4

SECONDARY outcome

Timeframe: 6 weeks

Population: 1 patient declined to complete the walking test

6 minute walk test

Outcome measures

Outcome measures
Measure	Intervention n=9 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=9 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Exercise Capacity	190 m Standard Deviation 63	175 m Standard Deviation 72

SECONDARY outcome

Timeframe: 6 weeks

patient reported exacerbations following 6 weeks of device usage

Outcome measures

Outcome measures
Measure	Intervention n=10 Participants Single arm, open labelled study Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm	Usual Care n=10 Participants Usual care including non-invasive ventilation Usual care: usual care crossover trial, as per intervention
Exacerbation Frequency	0 exacerbations	0 exacerbations

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gill Arbane, Clinical trials coordinator

GSTT

Phone: 02071888070

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place