Optimizing NIPPV Use for Patients With ALS

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University of Pittsburgh

Status

Completed

Conditions

ALS

Treatments

Behavioral: Data Card Report

Study type

Interventional

Funder types

Other

Identifiers

NCT01035476
ALSA-P-2008-09

Details and patient eligibility

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

31 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy 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

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

31 participants in 2 patient groups

Data Card Report
Experimental group
Description:
Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.
Treatment:
Behavioral: Data Card Report
Standard NIPPV Care
No Intervention group
Description:
Patients receive routine monitoring and care related to NIPPV.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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