Optimizing NIPPV Use for Patients With ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01035476
Recruitment Status : Completed
First Posted : December 18, 2009
Last Update Posted : January 7, 2016
ALS Association
Information provided by (Responsible Party):
Steven M. Albert, University of Pittsburgh

December 16, 2009
December 18, 2009
January 7, 2016
December 2009
May 2011   (Final data collection date for primary outcome measure)
Length of time on NIPPV [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01035476 on Archive Site
Patient sleep quality, mood, fatigue [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
Optimizing NIPPV Use for Patients With ALS
Effectiveness Trial of Detailed NIPPV Feedback to Patients
This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.
The data card records critical features of NIPPV acceptance (hours and timing of use) and adherence (apnea/hypopnea index, mask leak, minute ventilation); but to date data card monitoring has not yet been incorporated fully into ALS clinic practice. We will limit our focus to patients who meet Medicare-reimbursement criteria or AAN-recommended practice parameters for initiating NIPPV. The larger question guiding this research is whether data card monitoring and communication of these results to clinicians and patient families promotes "optimal use" of NIPPV. We define optimal use as (i) high acceptance, as indicated by daily night time use greater than 4 hours, and (ii) high adherence, as indicated by apnea/hypopnea index, mask leak, and minute ventilation. We will test whether timely reporting of acceptance and adherence values to patients and clinicians increases the likelihood of (i) changes in orofacial masks and settings on devices and continued use of devices, and (ii) positive patient mood and sleep quality and lower caregiver burden over follow-up.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Behavioral: Data Card Report
Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
  • Experimental: Data Card Report
    Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.
    Intervention: Behavioral: Data Card Report
  • No Intervention: Standard NIPPV Care
    Patients receive routine monitoring and care related to NIPPV.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Definite or probable ALS
  • Medicare or AAN criteria for initiating NIPPV
  • Community resident
  • English speaker

Exclusion Criteria:

  • Unable to give informed consent
  • Other pulmonary or cardiac conditions that complicate use of NIPPV
  • Report from physician that participation would be harmful
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Steven M. Albert, University of Pittsburgh
University of Pittsburgh
ALS Association
Principal Investigator: Steven Albert, PhD University of Pittsburgh
Study Director: David Lacomis, MD University of Pittsburgh
University of Pittsburgh
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP