NCT01035476

Optimizing NIPPV Use for Patients With ALS

Effectiveness Trial of Detailed NIPPV Feedback to Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• ALS

Interventions

Type	Name	Description
BEHAVIORAL	Data Card Report	Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-05-01
• Completion: 2011-12-01
• First posted: 2009-12-18
• Last updated: 2016-01-07

Locations

1 site across 1 country: United States