Amyotrophic Lateral SclerosisNCT05106569
Telespirometry in Amyotrophic Lateral Sclerosis (ALS)
An observational study of Amyotrophic Lateral Sclerosis, run by State University of New York - Upstate Medical University at 2 sites in United States.
Trial summary
The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Spirometry
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Apr 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.
Who may be able to join
- Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS
- 18 years old to 100 years old, English-speaking ALS subjects, male and female
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atrium Health
Charlotte, North Carolina, 28211
SUNY Upstate
Syracuse, New York, 13210
About this study
Official title: Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)
The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Spirometry
- Keywords
- Pulmonary Function Test, Amyotrophic Lateral Sclerosis, Slow Vital Capacity
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
Also called Pulmonary Function 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.
| Study group | Role | What they receive |
|---|---|---|
| SUNY Upstate | One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. Receives: Diagnostic Test: Spirometry | |
| Atrium Health | One of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. Receives: Diagnostic Test: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)
Minimum 0, Maximum 48; Lower scores worse
Measured: 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
Measured: 3 months
Change from baseline SVC percent predicted at clinic
SVC measured at clinic in seated and supine positions using conventional and portable spirometer
Measured: 6 months
Change from baseline SVC percent predicted at home
SVC measured from home in seated and supine positions using portable spirometer
Measured: 2 week intervals for 6 months
Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)
Minimum 0, Maximum 30; Higher scores worse
Measured: 2 week intervals for 6 months
Change from baseline Hospital Anxiety and Depression Scale (HADS)
Minimum 0, Maximum 42; Higher scores worse
Measured: 6 months
Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months
Minimum 0, Maximum 20; Higher scores worse
Measured: 6 months
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)
Minimum 0, Maximum 20; Lower scores worse
Measured: 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
Measured: 6 months
Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire
Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices
Measured: 2 week intervals for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start28 Apr 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanabe Pharma America, Inc.
- Responsible party
- Principal investigator, Eufrosina I. Young, State University of New York - Upstate Medical University
- Investigators
- Eufrosina Young, MD, Principal investigator, SUNY Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106569
- Sponsor's protocol ID
- 1660190
- Status last verified
- Jun 2023
- First submitted
- 7 Oct 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The plan is to share Individual Patient Data collected during the study to research team from both sites.
Publications
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.
PubMed 30957547Hegewald 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.
PubMed 27598295Couratier 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.
PubMed 16319028Masa 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.
PubMed 20650985Graham 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.
PubMed 31613151Rutkove 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.
PubMed 30486680
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT05106569
- Acronym / sponsor ID
- 1660190
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Pulmonary Function Test, Amyotrophic Lateral Sclerosis, Slow Vital Capacity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Tanabe Pharma America, Inc.
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUNY Upstate | – | Diagnostic Test: SpirometryOne of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. |
| Atrium Health | – | Diagnostic Test: SpirometryOne of 2 ALS certified treatment centers in USA expected to recruit 50 subjects. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are invited to volunteer and recruited from ALS specialty care outpatient clinics at SUNY Upstate and Atrium Health.
Key inclusion criteria (2 listed)
- Diagnosis of ALS as Clinically Possible, Clinically Probable, Laboratory-supported Probable and Clinically Definite ALS
- 18 years old to 100 years old, English-speaking ALS subjects, male and female
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryAlso: Pulmonary Function TestAll 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. | Diagnostic test | Atrium Health, SUNY Upstate |
Primary outcome
Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR)
Time frame: 2 week intervals for 6 months
Minimum 0, Maximum 48; Lower scores worse
Change from baseline SVC percent predicted at clinic
Time frame: 3 months
SVC measured at clinic in seated and supine positions using conventional and portable spirometer
Change from baseline SVC percent predicted at clinic
Time frame: 6 months
SVC measured at clinic in seated and supine positions using conventional and portable spirometer
Change from baseline SVC percent predicted at home
Time frame: 2 week intervals for 6 months
SVC measured from home in seated and supine positions using portable spirometer
Change from baseline Dyspnea in Amyotrophic Lateral Sclerosis 15 (DALS-15)
Time frame: 2 week intervals for 6 months
Minimum 0, Maximum 30; Higher scores worse
Change from baseline Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Minimum 0, Maximum 42; Higher scores worse
Change from baseline Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 6 months
Time frame: 6 months
Minimum 0, Maximum 20; Higher scores worse
Change from baseline Amyotrophic Lateral Sclerosis Cognitive Behavioral Screen (ALS-CBCS)
Time frame: 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
Time frame: 6 months
Minimum 0, Maximum 45; Lower scores worse
Change from baseline Amyotrophic Lateral Sclerosis Treatment Questionnaire
Time frame: 2 week intervals for 6 months
Reports usage of non-invasive ventilation, gastrostomy tube, ALS medications and ALS devices
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 30957547Geronimo 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.
- Background: PubMed 27598295Hegewald 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.
- Background: PubMed 16319028Couratier 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.
- Background: PubMed 20650985Masa 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.
- Background: PubMed 31613151Graham 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.
- Results publication: PubMed 30486680Rutkove 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.
- Individual participant dataSharing planned: Yes. The plan is to share Individual Patient Data collected during the study to research team from both sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eufrosina Young, MD principal investigator
SUNY Upstate
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by State University of New York - Upstate Medical University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ALS Functional Rating Scale, Revised (ALS FRSR) (time frame: 2 week intervals for 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106569, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.