NCT01154283

Brief Summary

The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV) without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard, Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of life, patient satisfaction, and side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

June 29, 2010

Results QC Date

September 26, 2015

Last Update Submit

November 3, 2016

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Hours of NIPPV Usage

    Patients experienced the first intervention period during weeks 1-6 and the second intervention period during weeks 7-12. Patients were given one week to learn how to use the NIPPV equipment at the beginning of each intervention period. Therefore, only the total NIPPV hours used during the last 5 weeks of each intervention period were collected and divided by the number of weeks to obtain the average, weekly hours of NIPPV usage assessed at 6 weeks (first intervention) and 12 weeks (second intervention) for each patient.

    Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)

Secondary Outcomes (3)

  • Patient Preference (Likert Scale) "Definitely IPAP-only" "Probably IPAP-only" "Uncertain" "Probably Bi-level" "Definitely Bi-level"

    Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)

  • Transitional Dyspnea Index

    Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)

  • EuroQol Visual Analogue Scale(VAS)

    Assessed at 6 weeks (first intervention) and 12 weeks (second intervention)

Study Arms (2)

Bi-level, standard, NIPPV

ACTIVE COMPARATOR

Standard NIPPV with both an inspiratory and expiratory positive airway pressure.

Device: Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine)

IPAP-only, NIPPV

EXPERIMENTAL

NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure

Device: Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine)

Interventions

Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine)DEVICE

Noninvasive positive airway pressure ventilation

Bi-level, standard, NIPPVIPAP-only, NIPPV

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years
  • Definite or probable ALS by El Escorial criteria
  • Maximal inspiratory force \< 60 cm/H2O or FVC \<50% predicted (American College of Chest Physicians' criteria for initiating NIPPV)
  • Patients must have used NIPPV (typically administered as BiPAP) for at least 2 months
  • Currently using NIPPV ≥5 days a week with an EPAP = 4 cm H2O.

You may not qualify if:

  • Any medical condition that will interfere with participation
  • Inability to consent for him/herself
  • Known obstructive sleep apnea or obstructive pulmonary disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Kirsten Gruis
Organization
UMichigan
klgruis@gmail.com
7346041172

Study Officials

  • Kirsten Gruis, MD

    University of Michigan

    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
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 29, 2010

First Posted

June 30, 2010

Study Start

January 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 2, 2017

Results First Posted

January 2, 2017

Record last verified: 2016-11

Locations

US(1)