Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Volume Targeted Versus Pressure Targeted Non-invasive Ventilation in Amyotrophic Lateral Sclerosis: a Randomised Control Trial.
NCT number | NCT05328492 |
Other study ID # | EP545921 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2022 |
Est. completion date | March 15, 2024 |
The purpose of this study is to assess the efficacy of using intelligent volume assured pressure support (iVAPS-AE) versus spontaneous timed (ST) modes of non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS). The investigators believe that the use of iVAPS-AE mode NIV over a 90 day period will produce NIV compliance data and health-related quality of life (HRQOL) scores that are equivalent or no worse compared to ST mode NIV.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 15, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: Patients with respiratory failure secondary to ALS (diagnosed either at an MND MDT or specialist neurology clinic) according to criteria set out in the NICE guideline (NG42) (2016); Motor neurone disease: assessment and management. - Patients able to provide informed consent to take part in the research study. - Patients not contraindicated to commence NIV in accordance with local protocol. - Patients not currently enrolled in another research study that could alter disease progression. Exclusion Criteria: - Acutely unwell or medically complicated patients as assessed by lead investigator. These patients will be urgently reviewed by a dedicated Consultant Physician. The Principal Investigator will be immediately informed. - An inability to provide informed consent. - An inability to use NIV. - Patients whom are contraindicated to commence NIV in accordance with local protocol. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Coventry and Warwickshire NHS Trust | Coventry | West Midlands |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust |
United Kingdom,
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Gruis KL, Brown DL, Lisabeth LD, Zebarah VA, Chervin RD, Feldman EL. Longitudinal assessment of noninvasive positive pressure ventilation adjustments in ALS patients. J Neurol Sci. 2006 Aug 15;247(1):59-63. doi: 10.1016/j.jns.2006.03.007. Epub 2006 Apr 24. — View Citation
Kim SM, Park KS, Nam H, Ahn SW, Kim S, Sung JJ, Lee KW. Capnography for assessing nocturnal hypoventilation and predicting compliance with subsequent noninvasive ventilation in patients with ALS. PLoS One. 2011 Mar 30;6(3):e17893. doi: 10.1371/journal.pone.0017893. — View Citation
Kleopa KA, Sherman M, Neal B, Romano GJ, Heiman-Patterson T. Bipap improves survival and rate of pulmonary function decline in patients with ALS. J Neurol Sci. 1999 Mar 15;164(1):82-8. doi: 10.1016/s0022-510x(99)00045-3. — View Citation
Lo Coco D, Marchese S, Pesco MC, La Bella V, Piccoli F, Lo Coco A. Noninvasive positive-pressure ventilation in ALS: predictors of tolerance and survival. Neurology. 2006 Sep 12;67(5):761-5. doi: 10.1212/01.wnl.0000227785.73714.64. Epub 2006 Aug 9. — View Citation
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Morelot-Panzini C, Bruneteau G, Gonzalez-Bermejo J. NIV in amyotrophic lateral sclerosis: The 'when' and 'how' of the matter. Respirology. 2019 Jun;24(6):521-530. doi: 10.1111/resp.13525. Epub 2019 Mar 25. — View Citation
NICE. Recommendations | Motor neurone disease: assessment and management | Guidance | NICE [Internet]. NICE; 2016 [cited 2021 May 10]. Available from: https://www.nice.org.uk/guidance/NG42/chapter/Recommendations#prognostic-factors
Nicholson TT, Smith SB, Siddique T, Sufit R, Ajroud-Driss S, Coleman JM 3rd, Wolfe LF. Respiratory Pattern and Tidal Volumes Differ for Pressure Support and Volume-assured Pressure Support in Amyotrophic Lateral Sclerosis. Ann Am Thorac Soc. 2017 Jul;14(7):1139-1146. doi: 10.1513/AnnalsATS.201605-346OC. — View Citation
Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luis ML. Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26. doi: 10.1016/0022-510x(95)00052-4. — View Citation
Rabec C, Rodenstein D, Leger P, Rouault S, Perrin C, Gonzalez-Bermejo J; SomnoNIV group. Ventilator modes and settings during non-invasive ventilation: effects on respiratory events and implications for their identification. Thorax. 2011 Feb;66(2):170-8. doi: 10.1136/thx.2010.142661. Epub 2010 Oct 14. — View Citation
Raheja D, Stephens HE, Lehman E, Walsh S, Yang C, Simmons Z. Patient-reported problematic symptoms in an ALS treatment trial. Amyotroph Lateral Scler Frontotemporal Degener. 2016;17(3-4):198-205. doi: 10.3109/21678421.2015.1131831. Epub 2016 Jan 29. — View Citation
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Sancho J, Servera E, Morelot-Panzini C, Salachas F, Similowski T, Gonzalez-Bermejo J. Non-invasive ventilation effectiveness and the effect of ventilatory mode on survival in ALS patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Mar;15(1-2):55-61. doi: 10.3109/21678421.2013.855790. Epub 2013 Nov 25. — View Citation
Vitacca M, Banfi P, Montini A, Paneroni M. Does timing of initiation influence acceptance and adherence to NIV in patients with ALS? Pulmonology. 2020 Jan-Feb;26(1):45-48. doi: 10.1016/j.pulmoe.2019.05.007. Epub 2019 Jun 5. — View Citation
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Home NIV Compliance | Measured in hours per night | 90 days | |
Secondary | Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) | A 12-item questionnaire to monitor the disease progression covering bulbar, motor and respiratory function. Total scores range from 0 to 48. Higher scores indicate better function. | Baseline, 14, 30, 60, 90 days | |
Secondary | Severe Respiratory Insufficiency Questionnaire (SRI) | A 49-item questionnaire to measure health related quality of life in patients receiving long term non-invasive ventilation (NIV). Total scores range from 49 to 245. Higher scores indicate worse outcomes. | Baseline, 14, 30, 60, 90 days | |
Secondary | Modified Hospital Anxiety and Depression Score (mHADS) | A 14-item questionnaire to measure anxiety and depression levels. The questionnaire consists of anxiety sub-scale and depression sub-scale. Scores for each sub-scale range from 0 to 21. Higher scores indicate greater anxiety/depression levels. This version is modified for use in patients diagnosed with amyotrophic lateral sclerosis (ALS). | Baseline, 14, 30, 60, 90 days |
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