Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

NCT05106569 | Unknown FDA Device

• 1 other identifier: 1660190
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Pulmonary Function Test; Amyotrophic Lateral Sclerosis; Slow Vital Capacity

Outcome Measures

Primary Outcomes (10)

• Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)

  Minimum 0, Maximum 48; Lower scores worse

  2 week intervals for 6 months

• Change from baseline SVC percent predicted at clinic

  SVC measured at clinic in seated and supine positions using conventional and portable spirometer

  3 months

• Change from baseline SVC percent predicted at clinic

  SVC measured at clinic in seated and supine positions using conventional and portable spirometer

  6 months

• Change from baseline SVC percent predicted at home

  SVC measured from home in seated and supine positions using portable spirometer

  2 week intervals for 6 months

• Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)

  Minimum 0, Maximum 30; Higher scores worse

  2 week intervals for 6 months

• Change from baseline Hospital Anxiety and Depression Scale (HADS)

  Minimum 0, Maximum 42; Higher scores worse

  6 months

• Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months

  Minimum 0, Maximum 20; Higher scores worse

  6 months

• Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)

  Minimum 0, Maximum 20; Lower scores worse

  6 months

• Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months

  Minimum 0, Maximum 45; Lower scores worse

  6 months

• Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire

  Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices

  2 week intervals for 6 months

Study Arms (2)

SUNY Upstate

One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.

Diagnostic Test: Spirometry

Atrium Health

One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.

Diagnostic Test: Spirometry

Interventions

Spirometry DIAGNOSTIC_TEST

All study participants will undergo pulmonary function testing using conventional spirometry in clinic and portable spirometry in clinic and at home. In-clinic conventional laboratory spirometry is compared with portable spirometry and Slow vital capacity is obtained in upright and supine positions.

Also known as: Pulmonary Function Test

Atrium Health; SUNY Upstate

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.

You may qualify if:

• Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS
• years old to 100 years old, English-speaking ALS subjects, male and female

You may not qualify if:

• Use of non-invasive ventilation more than 16 hours daily
• Non-English Speaker
• Psychosis or severe mental illness
• Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance
• Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Tanabe Pharma America, Inc.: collaborator

Study Sites (2)

SUNY Upstate

Syracuse, New York, 13210, United States

Location

Atrium Health

Charlotte, North Carolina, 28211, United States

Location

Related Publications (6)

• Geronimo A, Simmons Z. Evaluation of remote pulmonary function testing in motor neuron disease. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):348-355. doi: 10.1080/21678421.2019.1587633. Epub 2019 Apr 7.

  PMID: 30957547 BACKGROUND

• Hegewald MJ, Gallo HM, Wilson EL. Accuracy and Quality of Spirometry in Primary Care Offices. Ann Am Thorac Soc. 2016 Dec;13(12):2119-2124. doi: 10.1513/AnnalsATS.201605-418OC.

  PMID: 27598295 BACKGROUND

• Couratier P, Vincent F, Torny F, Lacoste M, Melloni B, Lemaire F, Antonini MT. Spirometer-dependence of vital capacity in ALS: validation of a portable device in 52 patients. Amyotroph Lateral Scler Other Motor Neuron Disord. 2005 Dec;6(4):239-45. doi: 10.1080/14660820510043244.

  PMID: 16319028 BACKGROUND

• Masa JF, Gonzalez MT, Pereira R, Mota M, Riesco JA, Corral J, Zamorano J, Rubio M, Teran J, Farre R. Validity of spirometry performed online. Eur Respir J. 2011 Apr;37(4):911-8. doi: 10.1183/09031936.00011510. Epub 2010 Jul 22.

  PMID: 20650985 BACKGROUND

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

  PMID: 31613151 BACKGROUND

• Rutkove SB, Qi K, Shelton K, Liss J, Berisha V, Shefner JM. ALS longitudinal studies with frequent data collection at home: study design and baseline data. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):61-67. doi: 10.1080/21678421.2018.1541095. Epub 2018 Nov 28.

  PMID: 30486680 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Spirometry; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eufrosina Young, MD

  SUNY Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 3, 2021
• Study Start: April 28, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years.
• Access Criteria: Research team includes Principal investigators, sub-investigators, clinical research coordinators and respiratory therapists at each site, Pulmonologist Central Readers at SUNY Upstate. Deidentified data is shared with study sponsor MTPA.

Locations

US (2)