Trial Outcomes & Findings for Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV (NCT NCT01405313)
NCT ID: NCT01405313
Last Updated: 2017-03-20
Results Overview
Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by \>90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by \>30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.
COMPLETED
NA
21 participants
One night
2017-03-20
Participant Flow
Clinic population already established on ASV therapy.
All enrolled participants continued through to group assignment.
Participant milestones
| Measure |
First Modified ASV Then Conventional ASV
Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
Baseline characteristics by cohort
| Measure |
Modified ASV/Conventional ASV
n=21 Participants
Therapy used was Modified ASV and then Conventional ASV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One nightPhysiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by \>90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by \>30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.
Outcome measures
| Measure |
Modified ASV AHI
n=21 Participants
1 night of modified ASV therapy with full polysomnography measurements
|
Conventional ASV AHI
n=21 Participants
1 night of conventional ASV therapy with full polysomnography measurements
|
|---|---|---|
|
Apnea/Hypopnea Index (AHI)
|
3.9 Events per hour
Standard Deviation 4.7
|
6.4 Events per hour
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: One nightOxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.
Outcome measures
| Measure |
Modified ASV AHI
n=21 Participants
1 night of modified ASV therapy with full polysomnography measurements
|
Conventional ASV AHI
n=21 Participants
1 night of conventional ASV therapy with full polysomnography measurements
|
|---|---|---|
|
Oxygen Desaturation Index (ODI)
|
5.2 Events per hour
Standard Deviation 5.3
|
8.2 Events per hour
Standard Deviation 11.8
|
Adverse Events
Conventional ASV
Modified ASV
Serious adverse events
| Measure |
Conventional ASV
n=21 participants at risk
Intervention was conventional ASV therapy
|
Modified ASV
n=21 participants at risk
Intervention was modified ASV therapy
|
|---|---|---|
|
Cardiac disorders
Diagnostic Coronary Angiogram
|
4.8%
1/21 • Number of events 1
|
0.00%
0/21
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place