SensAwake™ Sleep Quality Trial (SASQT)

This study has been completed.
Sponsor:
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00811213
First received: December 16, 2008
Last updated: July 10, 2011
Last verified: July 2011
  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.

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811213

Locations
Australia, New South Wales
Woolcock Institute of Medical Research
Sydney, New South Wales, Australia, 2037
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 29, 2014