AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
ResMed
ClinicalTrials.gov Identifier:
NCT00252252
First received: November 9, 2005
Last updated: June 20, 2008
Last verified: June 2008
  Purpose

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).


Condition Intervention Phase
Chest Wall Disorder
Neuromuscular Disease
Device: VPAP non-invasive ventilator
Device: AutoVPAP non-invasive ventilator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.

Secondary Outcome Measures:
  • Compare tolerance of AutoVPAP versus standard VPAP
  • Compare effects on overnight heart rate variation (as a measure of autonomic stress)
  • Measure of hours of use of device
  • Measure of effect on daytime sleepiness

Enrollment: 20
Study Start Date: November 2005
Study Completion Date: December 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252252

Locations
United Kingdom
Royal Brompton Hospital
London, Greater London, United Kingdom, SW3 6NP
Sponsors and Collaborators
ResMed
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Anita Simonds, MD, FRCP Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided by ResMed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00252252     History of Changes
Other Study ID Numbers: 2005LF009B, REC Ref No 05/Q0404/001
Study First Received: November 9, 2005
Last Updated: June 20, 2008
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014