SensAwake™ Sleep Quality Trial (SASQT)

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.

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: SleepStyle 200 Auto Series with SensAwake; Device: SleepStyle 200 Auto Series with out SensAwake

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2037
      • Woolcock Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Wake After Sleep Onset (WASO) between treatment with standard APAP and APAP modified by the addition of the SensAwake™ modification	1 Night

Secondary Outcome Measures

Outcome Measure	Time Frame
Sleep Efficiency	1 night
Percentage of Slow Wave Sleep	1 night

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Brendon Yee, MBChB, Woolcock Institute of Medical Research

Publications and helpful links

General 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.

Helpful Links

• Sponsor site
• Study Site

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 10, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: FP-08E-108