Optimizing NIPPV Use for Patients With ALS

Not Applicable

Completed

• Conditions: ALS
• Interventions: Behavioral: Data Card Report

• Registration Number: NCT01035476
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-18
• Primary Completion: 2011-05
• Study Completion: 2011-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Definite or probable ALS
• Medicare or AAN criteria for initiating NIPPV
• Community resident
• English speaker

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Data Card Report	Data Card Report	Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.

Primary Outcome Measures

Name	Time	Method
Length of time on NIPPV	6 months

Secondary Outcome Measures

Name	Time	Method
Patient sleep quality, mood, fatigue	6 months

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States