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The SensAwakeâ„¢ 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 SensAwakeâ„¢. 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 SensAwakeâ„¢ 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 SensAwakeâ„¢ modification. The investigator and study staff will be blinded to the treatment of any participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled |
|
| 2 | Active Comparator | Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SleepStyle 200 Auto Series with SensAwake | Device | Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wake After Sleep Onset (WASO) between treatment with standard APAP and APAP modified by the addition of the SensAwakeâ„¢ modification | 1 Night |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Efficiency | 1 night | |
| Percentage of Slow Wave Sleep | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendon Yee, MBChB | Woolcock Institute of Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woolcock Institute of Medical Research | Sydney | New South Wales | 2037 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21677895 | Derived | Dungan GC 2nd, Marshall NS, Hoyos CM, Yee BJ, Grunstein RR. A randomized crossover trial of the effect of a novel method of pressure control (SensAwake) in automatic continuous positive airway pressure therapy to treat sleep disordered breathing. J Clin Sleep Med. 2011 Jun 15;7(3):261-7. doi: 10.5664/JCSM.1066. |
| Label | URL |
|---|---|
| Study Site | View source |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| SleepStyle 200 Auto Series with out SensAwake | Device | Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled |
|
| Sponsor site | View source |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |