Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: Spirometry

• Registration Number: NCT05106569
• Lead Sponsor: State University of New York - Upstate Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrium Health	Spirometry	One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.
SUNY Upstate	Spirometry	One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects.

Primary Outcome Measures

Name	Time	Method
Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)	2 week intervals for 6 months	Minimum 0, Maximum 30; Higher scores worse
Change from baseline Hospital Anxiety and Depression Scale (HADS)	6 months	Minimum 0, Maximum 42; Higher scores worse
Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months	6 months	Minimum 0, Maximum 20; Higher scores worse
Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)	2 week intervals for 6 months	Minimum 0, Maximum 48; Lower scores worse
Change from baseline SVC percent predicted at clinic	6 months	SVC measured at clinic in seated and supine positions using conventional and portable spirometer
Change from baseline SVC percent predicted at home	2 week intervals for 6 months	SVC measured from home in seated and supine positions using portable spirometer
Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire	2 week intervals for 6 months	Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)	6 months	Minimum 0, Maximum 20; Lower scores worse
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS) ALS Caregiver Behavioral Questionnaire at 6 months	6 months	Minimum 0, Maximum 45; Lower scores worse

Trial Locations

Locations (2)

SUNY Upstate; 🇺🇸 Syracuse, New York, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States