Optimizing NIPPV Use for Patients With ALS

ALS Clinical Trial

Official title:

Effectiveness Trial of Detailed NIPPV Feedback to Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035476
• Other study ID #: ALSA-P-2008-09
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: January 5, 2016
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ALS

Intervention

Behavioral:
• Data Card Report
Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of time on NIPPV		6 months	No
Secondary	Patient sleep quality, mood, fatigue		6 months	No