AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chest Wall Disorder Neuromuscular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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VPAP non-invasive ventilator

Intervention Type DEVICE

AutoVPAP non-invasive ventilator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anita Simonds, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Locations

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Royal Brompton Hospital

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

References

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Jaye J, Chatwin M, Dayer M, Morrell MJ, Simonds AK. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial. Eur Respir J. 2009 Mar;33(3):566-71. doi: 10.1183/09031936.00065008.

Reference Type DERIVED

PMID: 19251798 (View on PubMed)

Other Identifiers

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REC Ref No 05/Q0404/001

Identifier Type: -

Identifier Source: secondary_id

2005LF009B