Comparison of Auto-Adjusting Positive Airway Pressure Devices

Overview

Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2015

Interventions

  • Device: APAP A (ResMed AirSense AutoSet)
    • Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
  • Device: APAP B (Apex iCH Auto)
    • Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events

Arms, Groups and Cohorts

  • Active Comparator: Group 1
    • Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 1) will use APAP A on the first night of the evaluation, and APAP B on the second night.
  • Active Comparator: Group 2
    • Patients will be randomised to either Group 1 or Group 2. Patients in this group (group 2) will use APAP B on the first night of the evaluation and APAP A on the second night.

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the efficacy of two different auto-adjusting PAP devices through comparison of apnea hypopnoea index (AHI)/ oxygen desaturation index (ODI) of Device A compared with Device B
    • Time Frame: 2 nights

Participating in This Clinical Trial

Inclusion Criteria

  • Males aged ≥ 18 years
  • Recently diagnosed with OSA (AHI ≥15). Recently defined as less than 3 months before study entry
  • Naive to CPAP therapy
  • Participants willing and able to give written informed consent

Exclusion Criteria

  • Participants requiring Bi-level PAP
  • Participants requiring supplemental oxygen
  • Participants who are pregnant
  • Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ResMed
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ingo Fietz, Prof, Principal Investigator, Charite Center of Sleep Medicine

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