NCT01035476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

December 16, 2009

Last Update Submit

January 5, 2016

Conditions

ALS

Keywords

ALSnasal ventilationdata card recording

Outcome Measures

Primary Outcomes (1)

  • Length of time on NIPPV

    6 months

Secondary Outcomes (1)

  • Patient sleep quality, mood, fatigue

    6 months

Study Arms (2)

Data Card Report

EXPERIMENTAL

Patients receive detailed reports of acceptance and adherence, with linked recommendations to optimize NIPPV.

Behavioral: Data Card Report

Standard NIPPV Care

NO INTERVENTION

Patients receive routine monitoring and care related to NIPPV.

Interventions

Data Card ReportBEHAVIORAL

Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.

Data Card Report

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable to give informed consent
  • Other pulmonary or cardiac conditions that complicate use of NIPPV
  • Report from physician that participation would be harmful

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Study Officials

  • Steven Albert, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • David Lacomis, MD

    University of Pittsburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 18, 2009

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

US(1)