Amyotrophic Lateral SclerosisNCT04305639
The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
An observational study of Amyotrophic Lateral Sclerosis and Dyspnea, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Dyspnea
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 8 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with Amyothrophic Lateral Sclerosis
Who may be able to join
- Age of 18 or above
- Dyspnea on exertion, dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea
Who cannot join
- Severe cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.
- Conditions
- Amyotrophic Lateral Sclerosis, Dyspnea
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dyspnea-ALS-Scale (DALS-15)
The scale is used to measure dyspnea in ALS patients
Measured: 10 minutes
Secondary outcomes (2)
Modified Borg Scale
A 10 point Modified Borg Scale is used to assess dyspnea in supine and standing positions.
Measured: 10 minutes
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)
It is used to assess functional stats in ALS patients. This study particularly focus on pulmonary functions and dyspnea subscale of the scale.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Sep 2020
- Primary completion1 Apr 2021
- Study completion8 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Istanbul University
- Responsible party
- Principal investigator, Esma Nur KOLBAŞI, Istanbul Medeniyet University
- Investigators
- ESMA NUR KOLBAŞI, MSc, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305639
- Sponsor's protocol ID
- IstanbulMU4
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2020
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
- ClinicalTrials.gov ID
- NCT04305639
- Acronym / sponsor ID
- IstanbulMU4
- Conditions
- Amyotrophic Lateral Sclerosis, Dyspnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Istanbul University
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 12 Mar 2020 (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 Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with Amyothrophic Lateral Sclerosis
Key inclusion criteria (2 listed)
- Age of 18 or above
- Dyspnea on exertion, dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea
Key exclusion criteria (1 listed)
- Severe cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Dyspnea-ALS-Scale (DALS-15)
Time frame: 10 minutes
The scale is used to measure dyspnea in ALS patients
2 secondary outcomes
Modified Borg Scale
Time frame: 10 minutes
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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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.
ESMA NUR KOLBAŞI, MSc principal investigator
Istanbul Medeniyet University
1 site 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 and Dyspnea, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Dyspnea-ALS-Scale (DALS-15) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2021.