Telespirometry in Amyotrophic Lateral Sclerosis (ALS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-28

Study Completion Date

2024-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SUNY Upstate

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

Spirometry

Intervention Type 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.

Atrium Health

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

Spirometry

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Pulmonary Function Test

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No