NCT00811213

SensAwake™ Sleep Quality Trial

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	SleepStyle 200 Auto Series with SensAwake	Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology enabled
DEVICE	SleepStyle 200 Auto Series with out SensAwake	Auto adjusting Continuous Postive Aiway Pressure (CPAP) Device with SensAwake technology disabled

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-08-01
• First posted: 2008-12-18
• Last updated: 2011-07-12

Locations

1 site across 1 country: Australia