Servo-Ventilation In-lab PSG Evaluation
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/21/2019 |
| Start Date: | November 9, 2015 |
| End Date: | July 6, 2017 |
Servo-Ventilation In-lab Polysomnography (PSG) Evaluation
Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents
instability and collapse. With a stable and patent airway, breathing continues in a normal
manner, gas exchange is improved, and there is no disruption of sleep related to disturbed
breathing.
Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat
obstructive and complex central sleep apnea. The main features of the Auto SV mode include:
- Normalization of ventilation by automatically adjusting Inspiratory Positive Airway
Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased
to help stabilize the ventilation.
- Provision of timed, back-up breaths during central apneas. The optimal back-up rate is
automatically determined by the device based on the patient's breathing.
- Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive
events.
Several manufacturers produce these types of devices. The algorithms used to determine the
IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices
currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville
PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents
instability and collapse. With a stable and patent airway, breathing continues in a normal
manner, gas exchange is improved, and there is no disruption of sleep related to disturbed
breathing.
Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat
obstructive and complex central sleep apnea. The main features of the Auto SV mode include:
- Normalization of ventilation by automatically adjusting Inspiratory Positive Airway
Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased
to help stabilize the ventilation.
- Provision of timed, back-up breaths during central apneas. The optimal back-up rate is
automatically determined by the device based on the patient's breathing.
- Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive
events.
Several manufacturers produce these types of devices. The algorithms used to determine the
IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices
currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville
PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).
This study is to better understand the performance and features of the BiPAP autoSV Advanced
System One. Philips Respironics will evaluate the PolySomnoGraphy (PSG) and Encore data from
each night. The aim of the study is to characterize the acute outcomes of treatment provided
by the device and evaluate any modifications made to the Philips Respironics device's
algorithm
The participants for this study will be experienced in having used servo ventilation therapy
at their home because it is only such patients who are already using servo ventilation as
part of routine clinical care that are eligible for participation.
Participants will receive four (4) randomized PSG's during which they will receive treatment
from the following devices in a randomized manner:
- FDA released Philips BiPAP AutoSV Advanced System One
- A Modified Philips BiPAP ASV
- FDA released ResMed S7 VPAP Adapt
- FDA released ResMed S9 VPAP Adapt
The participants sought for this effort will be previously prescribed a servo-ventilation
device as part of routine clinical care.
Baseline with PSG
- Informed Consent
- Inclusion/Exclusion Criteria Review
- Demographics
- Anthropometric Measurements
- PAP Prescription information (if available; from Device or from Medical records). This
is the pressure settings of the device that was prescribed by the patient's clinical
sleep medicine provider.
- Medical History and physical examination
- Sleep History- Including that past 30 day detailed report
- Diagnostic PSG history (copies of sleep studies that were performed as part of routine
clinical care in the past that qualified the patient for the servo-ventilation device)
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to a device Procedures for Each PSG after Baseline
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to one of the four devices (4 research PSGs will be
performed for each subject).
30 day Take Home with Modified Philips BiPAP ASV device
After the last PSG participants will be sent home on Modified Philips Auto Servo Ventilation
(ASV) study device. A wireless modem with oxygen saturation level (SPO2) connection will be
connected to the Modified Philips ASV study device. The wireless modem with SPO2 connection
is for device data collection/transmission purposes only that monitors the usage and
performance of the device in the home-setting.
- The device setting should be set to the following:
- P max: 30
- EPAP min: 4
- Expiratory Positive Airway Pressure maximum (EPAPmax):15
- Pressure Support Minimum (PS min): 0
- Pressure Support Maximum (PS max): 15
- BiFlex (Bi-Level Flex): 2
- Rate: Auto
After 30 day Take Home Participants Will
- Return to the Sleep Lab
- Complete the end of study questionnaire
- Return all of the study equipment
Additional Take Home with the Modified Philips BiPAP ASV device:
- Participants may be asked to use the Modified Philips ASV study device for an additional
30 days if more data is needed for analysis. Participants will complete the same end of
day questionnaire noted above.
After trial completion:
- When the Participant is done with the trial they will go back to using their own
prescribed device.
System One. Philips Respironics will evaluate the PolySomnoGraphy (PSG) and Encore data from
each night. The aim of the study is to characterize the acute outcomes of treatment provided
by the device and evaluate any modifications made to the Philips Respironics device's
algorithm
The participants for this study will be experienced in having used servo ventilation therapy
at their home because it is only such patients who are already using servo ventilation as
part of routine clinical care that are eligible for participation.
Participants will receive four (4) randomized PSG's during which they will receive treatment
from the following devices in a randomized manner:
- FDA released Philips BiPAP AutoSV Advanced System One
- A Modified Philips BiPAP ASV
- FDA released ResMed S7 VPAP Adapt
- FDA released ResMed S9 VPAP Adapt
The participants sought for this effort will be previously prescribed a servo-ventilation
device as part of routine clinical care.
Baseline with PSG
- Informed Consent
- Inclusion/Exclusion Criteria Review
- Demographics
- Anthropometric Measurements
- PAP Prescription information (if available; from Device or from Medical records). This
is the pressure settings of the device that was prescribed by the patient's clinical
sleep medicine provider.
- Medical History and physical examination
- Sleep History- Including that past 30 day detailed report
- Diagnostic PSG history (copies of sleep studies that were performed as part of routine
clinical care in the past that qualified the patient for the servo-ventilation device)
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to a device Procedures for Each PSG after Baseline
- Current Medications
- Vital Signs (at beginning of PSG night)
- Research Trial PSG- Randomized to one of the four devices (4 research PSGs will be
performed for each subject).
30 day Take Home with Modified Philips BiPAP ASV device
After the last PSG participants will be sent home on Modified Philips Auto Servo Ventilation
(ASV) study device. A wireless modem with oxygen saturation level (SPO2) connection will be
connected to the Modified Philips ASV study device. The wireless modem with SPO2 connection
is for device data collection/transmission purposes only that monitors the usage and
performance of the device in the home-setting.
- The device setting should be set to the following:
- P max: 30
- EPAP min: 4
- Expiratory Positive Airway Pressure maximum (EPAPmax):15
- Pressure Support Minimum (PS min): 0
- Pressure Support Maximum (PS max): 15
- BiFlex (Bi-Level Flex): 2
- Rate: Auto
After 30 day Take Home Participants Will
- Return to the Sleep Lab
- Complete the end of study questionnaire
- Return all of the study equipment
Additional Take Home with the Modified Philips BiPAP ASV device:
- Participants may be asked to use the Modified Philips ASV study device for an additional
30 days if more data is needed for analysis. Participants will complete the same end of
day questionnaire noted above.
After trial completion:
- When the Participant is done with the trial they will go back to using their own
prescribed device.
Inclusion Criteria:
- Ability to provide consent
- Age ≥ 21
- Currently prescribed servo ventilation therapy at home
- At least two weeks of recent adherence and efficacy data from PAP device demonstrating
adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14
nights)
- Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of
5 or more
Exclusion Criteria:
- Participants who are acutely ill, medically complicated or who are medically unstable
- Participants in whom PAP therapy is otherwise medically contraindicated
- Participants who are claustrophobic
- Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in
cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and
reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
- Participants with previously diagnosed respiratory failure or respiratory
insufficiency and who are known to have elevated arterial carbon dioxide levels while
awake (PaCO2 ≥ 55mmHg).
- Participants requiring any kind of oxygen therapy
- Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle
ear within the previous 90 days
- Participants with untreated, non-OSA sleep disorders, including but not limited to;
insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).
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