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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00811213




Registration number
NCT00811213
Ethics application status
Date submitted
16/12/2008
Date registered
18/12/2008
Date last updated
12/07/2011

Titles & IDs
Public title
SensAwake™ Sleep Quality Trial
Scientific 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.
Secondary ID [1] 0 0
FP-08E-108
Universal Trial Number (UTN)
Trial acronym
SASQT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SleepStyle 200 Auto Series with SensAwake
Treatment: Devices - SleepStyle 200 Auto Series with out SensAwake

Experimental: 1 - 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


Treatment: Devices: SleepStyle 200 Auto Series with SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled

Treatment: Devices: SleepStyle 200 Auto Series with out SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Wake After Sleep Onset (WASO) between treatment with standard APAP and APAP modified by the addition of the SensAwake™ modification
Timepoint [1] 0 0
1 Night
Secondary outcome [1] 0 0
Sleep Efficiency
Timepoint [1] 0 0
1 night
Secondary outcome [2] 0 0
Percentage of Slow Wave Sleep
Timepoint [2] 0 0
1 night

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2009
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2037 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00811213
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Brendon Yee, MBChB
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00811213