Study Purpose:The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV) without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard, Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of life, patient satisfaction, and side effects.
Amyotrophic Lateral Sclerosis
Type of Intervention:
Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine)
Study Chair(s)/Principal Investigator(s):
Kirsten Gruis, MD, University of Michigan
Coordinating Center Contact Information
University of Michigan
Ann Arbor, Michigan, 48109 United States
Full Study Summary:
The patients will have two additional study visits after the consent/training session: one at the end of 6 weeks, after the first NIPPV treatment period (prior to crossing over to the second NIPPV treatment), and the second at the end of 12 weeks, after the second NIPPV treatment period.
NIPPV usage will be recorded as hours of use as measured objectively by the NIPPV machine hour meter. When the patient returns for his/her first study visit at the end of week six, the NIPPV machine hour meter will be recorded by the study investigator. By subtracting the hours recorded at the beginning of week two from the hours recorded at the end of week six, the NIPPV hours of usage for weeks two, three, four, five and six will be obtained. This same procedure will be repeated to record NIPPV hours of usage for the beginning of week eight and the end of week twelve to measure the hours of usage with the second NIPPV set-up for weeks eight, nine, ten, eleven and twelve. This allows study subjects one week to adjust to the new pressure settings of each treatment arm.
Dyspnea as measured by the transition dyspnea index (TDI), and quality of life as measured by the EuroQol Visual analogue scale(VAS) will be re-administered at both 6 and 12 week study visits by study personnel. Lastly, patient preference of NIPPV treatment will be subjectively assessed at the 12 week study visit on a Likert scale (definitely first treatment, probably first treatment, no preference, probably second treatment, definitely second treatment).
Estimated Study Start Date:
12 / 31 / 2007
Estimated Study Completion Date:
10 / 01 / 2011
Posting Last Modified Date:
01 / 02 / 2017
Date Study Added to neals.org:
06 / 30 / 2010
1. Age greater than 18 years
2. Definite or probable ALS by El Escorial criteria
3. Maximal inspiratory force < 60 cm/H2O or FVC <50% predicted (American College of Chest Physicians' criteria for initiating NIPPV)
4. Patients must have used NIPPV (typically administered as BiPAP) for at least 2 months
5. Currently using NIPPV ≥5 days a week with an EPAP = 4 cm H2O.
1. Any medical condition that will interfere with participation
2. Inability to consent for him/herself
3. Known obstructive sleep apnea or obstructive pulmonary disease.
University of Michigan
Ann Arbor, Michigan