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Completed

NCT Number: NCT00252252

AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).

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Key information

Conditions

Chest Wall Disorder Nervous System Diseases Neuromuscular Disease Neuromuscular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Royal Brompton Hospital

London, Greater London, SW3 6NP, United Kingdom

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
  • Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 > 6.5 kPa when breathing spontaneously) with
  • Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
  • Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
  • All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
  • Able to understand treatment and protocol

Exclusion criteria

  • Unstable respiratory failure (PaO2 < 7.5 kPa, PaCO2 > 8.0 kPa,
  • Uncontrolled heart failure or arrhythmia
  • Moderate or severe bulbar weakness.
  • Unable to understand treatment or protocol

Treatment and study plan

VPAP non-invasive ventilator

Device

AutoVPAP non-invasive ventilator

Device

Primary outcomes

  1. Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.

Secondary outcomes

  1. Compare tolerance of AutoVPAP versus standard VPAP

  2. Compare effects on overnight heart rate variation (as a measure of autonomic stress)

  3. Measure of hours of use of device

  4. Measure of effect on daytime sleepiness

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Official study title

Crossover Trial of VPAP (Variable Positive Airway Pressure) Ventilation Versus AutoVPAP in Neuromuscular and Chest Wall Disease: Effects on Nocturnal Hypoventilation, Sleep Quality and Tolerance

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 11, 2005
Registry last updated
Jun 24, 2008

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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