SensAwake™ Sleep Quality Trial

NCT00811213 | Completed Phase 4

• 1 other identifier: FP-08E-108
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep Efficiency

  1 night

• Percentage of Slow Wave Sleep

  1 night

Study Arms (2)

1

EXPERIMENTAL

Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled

Device: SleepStyle 200 Auto Series with SensAwake

2

ACTIVE COMPARATOR

Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled

Device: SleepStyle 200 Auto Series with out SensAwake

Interventions

SleepStyle 200 Auto Series with SensAwake DEVICE

Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled

1

SleepStyle 200 Auto Series with out SensAwake DEVICE

Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

Location

Related Publications (1)

• 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.

  PMID: 21677895 DERIVED

Related Links

• Study Site
• Sponsor site

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Brendon Yee, MBChB

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 18, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 12, 2011

Record last verified: 2011-07

Locations

AU (1)