Optimizing NIPPV Use for Patients With ALS
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About
This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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