Trial Outcomes & Findings for Sleep Disordered Breathing and Chronic Pain (NCT NCT01457014)
NCT ID: NCT01457014
Last Updated: 2016-02-19
Results Overview
The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
four full night Polysomnography (PSG's)
Results posted on
2016-02-19
Participant Flow
Participants were recruited from pain treatment centers and clinics by either Pain Center/Clinic staff or staff from a Sleep Testing facility.
74 participants were screened; 40 were excluded after completing the diagnostic PSG (did not meet the inclusion/exclusion criteria).
Participant milestones
| Measure |
Diagnostic Polysomnography (PSG)
A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
|
Continuous Positive Airway Pressure (CPAP)
Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Auto Mode (autoSV)
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Manual (Manual SV)
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode
|
|---|---|---|---|---|
|
First Night
STARTED
|
74
|
0
|
0
|
0
|
|
First Night
COMPLETED
|
34
|
0
|
0
|
0
|
|
First Night
NOT COMPLETED
|
40
|
0
|
0
|
0
|
|
Second Night
STARTED
|
0
|
12
|
11
|
11
|
|
Second Night
COMPLETED
|
0
|
12
|
11
|
11
|
|
Second Night
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Night
STARTED
|
0
|
11
|
11
|
12
|
|
Third Night
COMPLETED
|
0
|
11
|
11
|
12
|
|
Third Night
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Fourth Night
STARTED
|
0
|
11
|
12
|
11
|
|
Fourth Night
COMPLETED
|
0
|
11
|
12
|
11
|
|
Fourth Night
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Diagnostic Polysomnography (PSG)
A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
|
Continuous Positive Airway Pressure (CPAP)
Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Auto Mode (autoSV)
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Manual (Manual SV)
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode
|
|---|---|---|---|---|
|
First Night
Didn't meet inclusion/exclusion criteria
|
37
|
0
|
0
|
0
|
|
First Night
Withdrawal by Subject
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Sleep Disordered Breathing and Chronic Pain
Baseline characteristics by cohort
| Measure |
Total Group
n=34 Participants
34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
|
|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
|
Morphine equivalents
|
390.1 mEq
STANDARD_DEVIATION 338.1 • n=99 Participants
|
PRIMARY outcome
Timeframe: four full night Polysomnography (PSG's)Population: After the Diagnostic Polysomnography (PSG) each participant completed a night in each arm.
The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
Outcome measures
| Measure |
Diagnostic Polysomnography (PSG)
n=31 Participants
Baseline overnight Polysomnography (PSG)
|
CPAP
n=31 Participants
Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Auto Mode
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Manual
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode
|
|---|---|---|---|---|
|
Number of Sleep Related Events Per Hour
Apnea-hyopnea index
|
38.8 events/hour
Standard Deviation 31.1
|
17.4 events/hour
Standard Deviation 20.1
|
4.5 events/hour
Standard Deviation 7.3
|
7.6 events/hour
Standard Deviation 16.7
|
|
Number of Sleep Related Events Per Hour
Central Apnea Index
|
16.1 events/hour
Standard Deviation 18.8
|
8.4 events/hour
Standard Deviation 12.4
|
0.2 events/hour
Standard Deviation 0.8
|
0.2 events/hour
Standard Deviation 0.9
|
|
Number of Sleep Related Events Per Hour
Obstructive Apnea Index
|
9.7 events/hour
Standard Deviation 6.3
|
4.5 events/hour
Standard Deviation 6.3
|
0.3 events/hour
Standard Deviation 0.5
|
0.5 events/hour
Standard Deviation 1.1
|
|
Number of Sleep Related Events Per Hour
Hypopnea Index
|
14.8 events/hour
Standard Deviation 12.6
|
4.5 events/hour
Standard Deviation 5.1
|
4.6 events/hour
Standard Deviation 7.4
|
7.9 events/hour
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: four full night Polysomnography (PSG's)Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.
Outcome measures
| Measure |
Diagnostic Polysomnography (PSG)
n=31 Participants
Baseline overnight Polysomnography (PSG)
|
CPAP
n=31 Participants
Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Auto Mode
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Manual
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode
|
|---|---|---|---|---|
|
Percent Oxygen Saturation
Av. O2 saturation
|
92.9 percentage of oxygen saturation
Standard Deviation 3.4
|
94.6 percentage of oxygen saturation
Standard Deviation 2.3
|
94.6 percentage of oxygen saturation
Standard Deviation 2.6
|
94.5 percentage of oxygen saturation
Standard Deviation 3.2
|
|
Percent Oxygen Saturation
Min. O2 saturation
|
79.9 percentage of oxygen saturation
Standard Deviation 7.8
|
85.5 percentage of oxygen saturation
Standard Deviation 6.0
|
82.9 percentage of oxygen saturation
Standard Deviation 16.2
|
79.7 percentage of oxygen saturation
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: four full night Polysomnography (PSG's)Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.
Outcome measures
| Measure |
Diagnostic Polysomnography (PSG)
n=31 Participants
Baseline overnight Polysomnography (PSG)
|
CPAP
n=31 Participants
Airway pressure delivered at a constant pressure level.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Auto Mode
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
CPAP: continuous positive airway pressure
servo ventilation manual: servo ventilation titrated in manual mode
|
Servo Ventilation Manual
n=31 Participants
Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation manual: servo ventilation titrated in manual mode
|
|---|---|---|---|---|
|
Number of Arterial Oxygen Saturation Per Hour
|
32.8 times per hour
Standard Deviation 29.2
|
15.1 times per hour
Standard Deviation 20.2
|
5.9 times per hour
Standard Deviation 8.6
|
9.5 times per hour
Standard Deviation 19.2
|
Adverse Events
Total Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Total Group
n=34 participants at risk
34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
|
|---|---|
|
Immune system disorders
Common Cold
|
8.8%
3/34
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.9%
2/34
|
|
Infections and infestations
Sinus Infection
|
8.8%
3/34
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
4/34
|
|
Infections and infestations
Ear Infection
|
5.9%
2/34
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place