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OpenTrials
Completed

NCT Number: NCT00906958

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Healthy Sleep

Bella Vista, New South Wales, 2135, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexus Flow Generator

Device

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.

VPAP Flow Generator 25

Device

Exiting VPAP Auto 25 Flow Generator with A10 Algorithm

Primary outcomes

  1. Apnoea-Hypopnoea Index (AHI)

    Time frame: One Night On Each Arm, approximately 8 hours each night

    The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto & VPAP Auto 25

  2. Oxygen Desaturation Index

    Time frame: One Night On Each Arm, approximately 8 hours each night

    Number of oxygen desaturations per hour of sleep

Secondary outcomes

  1. Comfort of Breathing

    Time frame: One Night On Each Arm, approximately 8 hours each night

    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

  2. Satisfaction of Treatment

    Time frame: One Night On Each Arm, approximately 8 hours each night

    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

  3. Refreshed Feel

    Time frame: One Night On Each Arm, approximately 8 hours each night

    Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 21, 2009
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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