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Systemic SclerosisNCT04484948

Utility of Breath-holding Test in Systemic Sclerosis

A study testing scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT in people with Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Systemic Sclerosis
What is being tested?
scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
12 Aug 2020to 31 May 2023
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
  • Must understand and voluntarily sign an informed consent form including writing consent for data protection

Who cannot join

  • The resting oxygen saturation by pulse oximetry < 90% in room air
  • Unstable angina or myocardial infarction during the previous month
  • Patients considered unable to the breath-holding test or 6 minute walk test

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Utility of Breath-holding Test for Assessment of Pulmonary Disease Severity in Patients With Systemic Sclerosis

This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

Read the detailed description

Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.

Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc.

Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.

Being tested
scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT
Keywords
Breath-holding test, Six minute walk test, Systemic sclerosis
Medical subject headings
Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWTOther

    1. Participants will perform the SHAQ.
    2. BHT and 6MWT will be performed in the randomized way for each participant.
    3. For BHT, the participants will be told to sit comfortably on a chair, and breath normally. After 1 minute, they were required to make a maximum expiration followed by a maximum inspiration and to hold the breath as long as possible at maximum inspiratory level. This procedure was repeated three times, with 5-minute intervals between the tests.
    4. 6MWT will be performed according to the ATS guidelines.
    5. Information on CXR, TTE, and PFT (FVC%, DLCO%) will be obtained from the medical record if the data was obtained within 3 months. If not, the tests will be performed.
    6. BHT and PFT will be followed by six months after the first breath-holding test to confirm the responsiveness.
    7. Additional 30 patients with systemic sclerosis will be collected to perform the test-retest reliability of BHT.
Study groups in NCT04484948
Study groupRoleWhat they receive
Systemic sclerosis groupExperimentalSystemic sclerosis diagnosis according to 2013 American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) classification criteria
Receives: Other: scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of breath-holding test with Borg Dyspnea Index

    Borg Scale on a 0-10 point

    Measured: Day 1 at inclusion

Secondary outcomes (5)

  1. Correlation of breath-holding time with 6 minute walk test (6MWT) distance

    6MWT distance measured in meters according to American Thoracic Society guidelines

    Measured: Day 1 at inclusion

  2. Correlation of breath-holding time with oxygen saturation during 6MWT

    Oxygen saturation monitored by wearable pulse oximeter (Radius PPG™ Tetherless Pulse Oximetry, Masimo Corp., Irvine, CA, USA)

    Measured: Day 1 at inclusion

  3. Correlation of breath-holding time with pulmonary function indices

    Pulmonary function indices including FVC (%) and DLCO (%)

    Measured: Day 1 at inclusion

  4. Correlation of breath-holding time with data on the echocardiography

    Echocardiography including left ventricular ejection fraction and pulmonary arterial systolic pressure (mmHg)

    Measured: Day 1 at inclusion

  5. Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ)

    SHAQ ranging from 0 to 3

    Measured: Day 1 at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2020
  2. Study start12 Aug 2020
  3. Primary completion29 Jan 2021
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484948
Sponsor's protocol ID
H-2006-054-1131
Status last verified
May 2023
First submitted
21 Jul 2020
Last updated
2 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hachulla E, Launay D. Diagnosis and classification of systemic sclerosis. Clin Rev Allergy Immunol. 2011 Apr;40(2):78-83. doi: 10.1007/s12016-010-8198-y.

    PubMed 20143182

  • Morelli S, Ferrante L, Sgreccia A, Eleuteri ML, Perrone C, De Marzio P, Balsano F. Pulmonary hypertension is associated with impaired exercise performance in patients with systemic sclerosis. Scand J Rheumatol. 2000;29(4):236-42. doi: 10.1080/030097400750041389.

    PubMed 11028845

  • Vandecasteele E, De Pauw M, De Keyser F, Decuman S, Deschepper E, Piette Y, Brusselle G, Smith V. Six-minute walk test in systemic sclerosis: A systematic review and meta-analysis. Int J Cardiol. 2016 Jun 1;212:265-73. doi: 10.1016/j.ijcard.2016.03.084. Epub 2016 Mar 25.

    PubMed 27057932

  • Impens AJ, Wangkaew S, Seibold JR. The 6-minute walk test in scleroderma--how measuring everything measures nothing. Rheumatology (Oxford). 2008 Oct;47 Suppl 5:v68-9. doi: 10.1093/rheumatology/ken273.

    PubMed 18784152

  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

    PubMed 12091180

  • Yeo J, Kim JY, Kim MH, Park JW, Park JK, Lee EB. Utility of the breath-holding test in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Oct 6;61(10):4113-4118. doi: 10.1093/rheumatology/keac020.

    PubMed 35040945

Questions about this trial

What is this clinical trial studying?

A study testing scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT in people with Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.

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 3 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 2 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 1 site in South Korea. 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?

Correlation of breath-holding test with Borg Dyspnea Index (time frame: Day 1 at inclusion). 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 NCT04484948, 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 2 Jun 2023.

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