Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea

The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Nexus Flow Generator; Device: VPAP Flow Generator 25

Detailed Description

Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bella Vista, New South Wales, Australia, 2135
      • Centre for Healthy Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18-80 years
• Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
• Patients who are using ResMed masks

Exclusion Criteria:

• Patients who are unable to provide written informed consent
• Patients who are unable to comprehend written and spoken English
• Patients who are using Bilevel PAP
• Patients who are pregnant

• Patients who are suffering any of the following:

  • Acute respiratory infection
  • Acute sinusitis, otitis media or perforated eardrum
  • Pneumothorax or pneumomediastinum
  • Recent history of severe epistaxis requiring medical attention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nexus Flow Generator; Participants were randomised to Nexus Flow Generator group for one night.	Device: Nexus Flow Generator; The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.
ACTIVE_COMPARATOR: VPAP Flow Generator 25; Participants were randomised to VPAP Flow Generator 25 group for one night.	Device: VPAP Flow Generator 25; Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnoea-Hypopnoea Index (AHI)	The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25	One Night On Each Arm, approximately 8 hours each night
Oxygen Desaturation Index	Number of oxygen desaturations per hour of sleep	One Night On Each Arm, approximately 8 hours each night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort of Breathing	Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale	One Night On Each Arm, approximately 8 hours each night
Satisfaction of Treatment	Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale	One Night On Each Arm, approximately 8 hours each night
Refreshed Feel	Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?	One Night On Each Arm, approximately 8 hours each night

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2009
• Primary Completion (ACTUAL): June 15, 2009
• Study Completion (ACTUAL): June 15, 2009

Study Registration Dates

• First Submitted: May 13, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (ESTIMATE): May 21, 2009

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

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
• Other Study ID Numbers: 08177-0608

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No