NCT00901485

Brief Summary

The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
10.3 years until next milestone

Results Posted

Study results publicly available

June 18, 2021

Completed
Last Updated

June 18, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

January 14, 2009

Results QC Date

April 14, 2021

Last Update Submit

May 24, 2021

Conditions

Nocturnal HypoventilationNeuromuscular DiseaseChest Wall Disorder

Keywords

Respiratory insufficiencyHypercapniaHypoventilationSleepPolysomnographyHypoxiaTitrationNon Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • Overnight Mean Oxygen Saturation

    Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.

    4 weeks

Secondary Outcomes (4)

  • Overnight Mean Transcutaneous Carbon Dioxide

    4 weeks

  • Overnight Peak Transcutaneous Carbon Dioxide

    4 weeks

  • Oxygen Desaturation Index (>4%)

    4 weeks

  • Sleep Quality: Arousal Index

    4 weeks

Other Outcomes (10)

  • Ventilator Adherence

    4 weeks

  • Median Overnight Minute Ventilation

    4 weeks

  • Median Overnight Pressure Support

    4 weeks

  • +7 more other outcomes

Study Arms (2)

autotitrating NIV

EXPERIMENTAL

approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation

Device: AutoVPAP

Standard non-invasive ventilation

ACTIVE COMPARATOR

approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation

Device: VPAPIIIST-A

Interventions

AutoVPAPDEVICE

Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.

Also known as: autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIV
autotitrating NIV
VPAPIIIST-ADEVICE

Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.

Also known as: standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAP
Standard non-invasive ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • new clinical diagnosis of nocturnal hypoventilation
  • requirement for long-term domiciliary non-invasive ventilation
  • no previous experience with domiciliary non-invasive ventilation

You may not qualify if:

  • uncontrolled cardiac failure
  • acute exacerbation of respiratory failure
  • daytime resting PaO2 \< 7.5kPa
  • moderate or severe bulbar weakness
  • inability to understand rationale and/or consent form for study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Neuromuscular DiseasesRespiratory InsufficiencyHypercapniaHypoventilationHypoxia

Condition Hierarchy (Ancestors)

Nervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Miss Julia Kelly
Organization
Royal Brompton Hospital
j.kelly@rbht.nhs.uk
+44 2073528121

Study Officials

  • Anita Simonds, MD, FRCP

    Royal Brompton & Harefield Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2009

First Posted

May 13, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 18, 2021

Results First Posted

June 18, 2021

Record last verified: 2021-05

Locations

GB(1)