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 I

Further study details as provided by ResMed:

Primary Outcomes: Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
Secondary Outcomes: 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
Expected Total Enrollment:  20

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00252252

Jay Jaye, BSc      0207 352 8121  Ext. 4183    j.jaye@rbht.nhs.uk

United Kingdom, Greater London
      Royal Brompton Hospital, London,  Greater London,  SW3 6NP,  United Kingdom

Study chairs or principal investigators

Anita Simonds, MD, FRCP,  Principal Investigator,  Royal Brompton Hospital NHS Trust   

Study ID Numbers:  2005LF009B; REC Ref No 05/Q0404/001
Last Updated:  December 8, 2005
Record first received:  November 9, 2005
ClinicalTrials.gov Identifier:  NCT00252252
Health Authority: United Kingdom: Department of Health
ClinicalTrials.gov processed this record on 2006-01-10