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

Brief Summary:
This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.

Condition or disease Intervention/treatment Phase
ALS Behavioral: Data Card Report Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness Trial of Detailed NIPPV Feedback to Patients
Study Start Date : December 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Data Card Report
Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.
Behavioral: Data Card Report
Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
No Intervention: Standard NIPPV Care
Patients receive routine monitoring and care related to NIPPV.

Primary Outcome Measures :
  1. Length of time on NIPPV [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Patient sleep quality, mood, fatigue [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035476

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
ALS Association
Principal Investigator: Steven Albert, PhD University of Pittsburgh
Study Director: David Lacomis, MD University of Pittsburgh

Responsible Party: Steven M. Albert, Professor, University of Pittsburgh Identifier: NCT01035476     History of Changes
Other Study ID Numbers: ALSA-P-2008-09
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by Steven M. Albert, University of Pittsburgh:
nasal ventilation
data card recording