Optimizing NIPPV Use for Patients With ALS

January 5, 2016 updated by: Steven M. Albert, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time on NIPPV
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient sleep quality, mood, fatigue
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

ALS Association

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (ESTIMATE)

December 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ALSA-P-2008-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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