Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05106569
• Other study ID #: 1660190
• Status: Enrolling by invitation
• Start date: April 28, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS

2. 18 years old to 100 years old, English-speaking ALS subjects, male and female

Exclusion Criteria:

1. Use of non-invasive ventilation more than 16 hours daily

2. Non-English Speaker

3. Psychosis or severe mental illness

4. Use of high-dose sedating psychotropic medications determined to potentially interfere with task performance

5. Infection Control issues and specific Pulmonary, Cardiac, Vascular contraindications as listed in the Standardization of Spirometry 2019 Update (Graham 2019)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Spirometry
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.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina
United States	SUNY Upstate	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Mitsubishi Tanabe Pharma America Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)	Minimum 0, Maximum 48; Lower scores worse	2 week intervals for 6 months
Primary	Change from baseline SVC percent predicted at clinic	SVC measured at clinic in seated and supine positions using conventional and portable spirometer	3 months
Primary	Change from baseline SVC percent predicted at clinic	SVC measured at clinic in seated and supine positions using conventional and portable spirometer	6 months
Primary	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
Primary	Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)	Minimum 0, Maximum 30; Higher scores worse	2 week intervals for 6 months
Primary	Change from baseline Hospital Anxiety and Depression Scale (HADS)	Minimum 0, Maximum 42; Higher scores worse	6 months
Primary	Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months	Minimum 0, Maximum 20; Higher scores worse	6 months
Primary	Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)	Minimum 0, Maximum 20; Lower scores worse	6 months
Primary	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
Primary	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