SensAwake™ Sleep Quality Trial

Sleep Apnea, Obstructive Clinical Trial

— SASQT  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811213
• Other study ID #: FP-08E-108
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2008
• Last updated: July 10, 2011
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2011
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• SleepStyle 200 Auto Series with SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
• SleepStyle 200 Auto Series with out SensAwake
Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Wake After Sleep Onset (WASO) between treatment with standard APAP and APAP modified by the addition of the SensAwake™ modification		1 Night	No
Secondary	Sleep Efficiency		1 night	No
Secondary	Percentage of Slow Wave Sleep		1 night	No

External Links

•   Sponsor site
•   Study Site