Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT02847299 - Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation N/A
Completed NCT02551406 - Prognostic Value of Residual Hypoventilation in Mechanically Ventilated Neuromuscular Patients N/A
Completed NCT00860951 - P300 Brain Computer Interface Keyboard to Operate Assistive Technology Phase 1/Phase 2
Recruiting NCT02288299 - Long-Term Effect of LIAM on Respiratory Performance in NIV Patients Suffering From Neuromuscular Disease N/A
Completed NCT02284022 - Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders. N/A
Completed NCT00001201 - Evaluation of Neuromuscular Disease N/A
Completed NCT02153970 - Calibration and Validation of the PROMIS and Neuro-QOL Questionnaires in Cerebral Palsy and Congenital Muscular Dystrophy
Terminated NCT02317042 - Juno Perth Clinical Trial N/A
Terminated NCT02022072 - Evaluation of Vital Capacity Phase 2
Recruiting NCT04417023 - B3 for NMD: Bench to Bedside and Back
Recruiting NCT02532244 - Genetics of Pediatric-Onset Motor Neuron and Neuromuscular Diseases
Completed NCT01621984 - Therapeutic Riding and Neuromuscular Disease Phase 1
Recruiting NCT01900132 - Electrical Impedance Myography: Natural History Studies inNeuromuscular Disorders and Healthy Volunteers N/A
Completed NCT00017745 - Phenotype/Genotype Correlations in Neuromuscular Disorders N/A
Recruiting NCT01560741 - Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation Phase 1
Completed NCT01644162 - Ventilator Monitoring in Early Exacerbation Detection N/A
Completed NCT00695591 - Home Sleep Testing in Neuromuscular Disease Patients N/A
Completed NCT01518439 - Instrumental and Manual Increase of Couch in Neuromuscular Patients N/A
Completed NCT01611597 - Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients N/A
Completed NCT01371149 - Patient -Ventilator Interaction in Chronic Respiratory Failure Phase 2