A Phase 4 interventional study of SleepStyle 200 Auto Series with SensAwake and SleepStyle 200 Auto Series with out SensAwake in Sleep Apnea, Obstructive, sponsored by Fisher and Paykel Healthcare. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-07-12.
Sponsored by Fisher and Paykel Healthcare · Phase 4, Interventional, and Treatment
The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA) and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial. Double-blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.
A total number of 45 participants will be recruited from an OSA population, aged 18-65. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the HREC, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to APAP or APAP with the addition of the SensAwake™ modification. The investigator and study staff will be blinded to the treatment of any participant.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 45 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Fisher and Paykel Healthcare is the lead sponsor of 84 studies on the registry; 15 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
Device: SleepStyle 200 Auto Series with SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Device: SleepStyle 200 Auto Series with out SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Change in Wake After Sleep Onset (WASO) between treatment with standard APAP and APAP modified by the addition of the SensAwake™ modification
Time frame: 1 Night
Sleep Efficiency
Time frame: 1 night
Percentage of Slow Wave Sleep
Time frame: 1 night
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Fisher and Paykel Healthcare