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Optimizing NIPPV Use for Patients With ALS

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT01035476
Collaborator
ALS Association (Other)
31
Enrollment
1
Location
2
Arms
24
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Data Card Report
 N/A

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 Design

Study Type:
Interventional
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 :
Dec 1, 2009
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Length of time on NIPPV [6 months]

Secondary Outcome Measures

  1. Patient sleep quality, mood, fatigue [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh Pittsburgh Pennsylvania United States 15261

Sponsors and Collaborators

  • University of Pittsburgh
  • ALS Association

Investigators

  • Principal Investigator: Steven Albert, PhD, University of Pittsburgh
  • Study Director: David Lacomis, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steven M. Albert, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01035476
Other Study ID Numbers:
  • ALSA-P-2008-09
First Posted:
Dec 18, 2009
Last Update Posted:
Jan 7, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Steven M. Albert, Professor, University of Pittsburgh
ALS
nasal ventilation
data card recording

Study Results

No Results Posted as of Jan 7, 2016