Optimizing NIPPV Use for Patients With ALS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness Trial of Detailed NIPPV Feedback to Patients

Conditions
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ALS

Intervention / Treatment
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* Behavioral: Data Card Report


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Data Card Report<br>Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV. | Behavioral: Data Card Report<br>* Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.<br>|
| No Intervention: Standard NIPPV Care<br>Patients receive routine monitoring and care related to NIPPV. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time on NIPPV |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient sleep quality, mood, fatigue |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS, nasal ventilation, data card recording