AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Neuromuscular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252252
• Other study ID #: 2005LF009B
• Secondary ID: REC Ref No 05/Q0
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2005
• Last updated: June 20, 2008
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Wall Disorder
• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

Device:
• VPAP non-invasive ventilator

• AutoVPAP non-invasive ventilator

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
Secondary	Compare tolerance of AutoVPAP versus standard VPAP
Secondary	Compare effects on overnight heart rate variation (as a measure of autonomic stress)
Secondary	Measure of hours of use of device
Secondary	Measure of effect on daytime sleepiness