Status:
TERMINATED
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Lead Sponsor:
Philips Respironics
Conditions:
Sleep Disordered Breathing
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3...
Detailed Description
Primary Hypothesis and end-point: The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to: ...
Eligibility Criteria
Inclusion
- Age 21-80.
- Ability to provide consent.
- Documentation of medical stability by investigator.
- Currently using BiPAP S/T (At least 4 weeks on therapy).
- Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.
Exclusion
- Participants, who are acutely ill, medically complicated or who are medically unstable.
- Participants in whom PAP therapy is otherwise medically contraindicated.
- Participants who are unwilling to wear PAP.
- Participants who are currently prescribed oxygen therapy.
- Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
- Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Participants with untreated, non-obstructive sleep apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome Periodic Limb Movement (PLM) Arousal Index \> 15).
- Participants who are unwilling to participate in the study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01241604
Start Date
January 1 2009
End Date
July 1 2009
Last Update
April 9 2019
Active Locations (1)
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1
Med One Medical Sleep Laboratory
Salt Lake City, Utah, United States, 84121