Effectiveness Trial of Detailed NIPPV Feedback to Patients

Study Purpose:

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

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS

Study Type:


Type of Intervention:


Intervention Name:



Phase 3

Study Chair(s)/Principal Investigator(s):

Steven Albert, PhD (University of Pittsburgh) Study Director: David Lacomis, MD (University of Pittsburgh)

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

University of Pittsburgh

Danielle Rowlands / 412-647-1706

Pittsburgh, Pennsylvania, 15261 United States

Full Study Summary:

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 Sponsor:

ALS Association

Estimated Enrollment:


Estimated Study Start Date:

11 / 30 / 2009

Estimated Study Completion Date:

11 / 02 / 2016

Posting Last Modified Date:

11 / 30 / 2011

Date Study Added to neals.org:

11 / 15 / 2011

Minimum Age:


Maximum Age:


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

University of Pittsburgh

Danielle Rowlands / 412-647-1706

Pittsburgh, Pennsylvania 15261
United States