Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
Stopped early · Not applicable
Conditions studied: Sleep Disordered Breathing
In brief
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 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
Key facts
- Study ID
- NCT01241604
- Run by
- Philips Respironics
- People needed
- 11
- Starts
- 2009-01-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2019-04-09
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Med One Medical Sleep Laboratory — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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