SensAwake™ Sleep Quality Trial (SASQT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea, Obstructive |
Device: SleepStyle 200 Auto Series with SensAwake Device: SleepStyle 200 Auto Series with out SensAwake |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | SASQT: SensAwake™ Sleep Quality Trial A Study to Test the Efficacy of the SensAwake™ Modification to Automatically Titrating Continuous Positive Airway Pressure to Reduce Wake After Sleep Onset in Patients With Moderate to Severe Obstructive Sleep Apnea. |
- 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 ] [ Designated as safety issue: No ]
- Sleep Efficiency [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Percentage of Slow Wave Sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 enabled
|
|
Active Comparator: 2
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 disabled
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18-65 years with moderate-to-severe OSA (Apnea Hypopnea index equal to or greater than 15 per hour).
- Epworth Sleepiness Scale (ESS) scores 0-15 inclusive (normal to moderately severe daytime sleepiness).
- Fluency in both written and spoken English.
- Do not have unstable psychiatric disease.
- No other significant sleep disorder.
Exclusion Criteria:
- Participants prescribed and fitted with any PAP device in the past 2 years.
- Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
- Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
- Participation in another clinical trial in the previous month.
Contacts and Locations| Australia, New South Wales | |
| Woolcock Institute of Medical Research | |
| Sydney, New South Wales, Australia, 2037 | |
| Principal Investigator: | Brendon Yee, MBChB | Woolcock Institute of Medical Research |
More Information
Additional Information:
No publications provided by Fisher and Paykel Healthcare
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jessica Hayward Clinical Research Scientist, Fisher & Paykel Healthcare |
| ClinicalTrials.gov Identifier: | NCT00811213 History of Changes |
| Other Study ID Numbers: | FP-08E-108 |
| Study First Received: | December 16, 2008 |
| Last Updated: | July 10, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013