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Vocal Intervention in Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02821663
Recruitment Status : Unknown
Verified April 2017 by Michael Mickel, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : July 1, 2016
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Michael Mickel, Medical University of Vienna

Brief Summary:
Systemic sclerosis is a systemic connective tissue disease with physical and mental disturbances. Based on a pilot study the feasibility and effectiveness of a novel, self-developed concept of vocal intervention in Systemic Sclerosis under vocal pedagogical guidance and music therapy is assessed.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Behavioral: vocal intervention Not Applicable

Detailed Description:
This concept aims at functional improvement of respiration and mouth-opening, enhancement of Quality of Life, and reduction of stress carried out by a music therapist and singer with pedagogical formation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation in Patients Suffering From Systemic Sclerosis by Vocal Intervention: A Pilot Study
Study Start Date : November 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Experimental: Vocal intervention
Vocal intervention
Behavioral: vocal intervention
10 x 60 min. sessions of vocal intervention

Primary Outcome Measures :
  1. MOS 36-Item Short Form Health Survey [ Time Frame: up to 4 weeks ]
    The SF-36 - a patient-reported survey of patient health - consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.

Secondary Outcome Measures :
  1. Mouth open; in millimeter [ Time Frame: up to 4 weeks ]
    incisor to incisor; corner of mouth to corner of mouth; measurement by tape

  2. 6-minutes walk test [ Time Frame: up to 4 weeks ]
    The 6-minute walk test assess changes in functional exercise capacity with the primary outcome reported being the distance walked during the test.

  3. Secretory immunoglobulin A; mg/l [ Time Frame: up to 4 weeks ]
    Immunoglobulin A is an antibody that plays a role in immune function in the mucous membranes. Indicates changes in immune status. Collected by a swab placed in the mouth.

  4. Saliva cortisol; ng/ml [ Time Frame: up to 4 weeks ]
    Cortisol is a steroid hormone indicating changes in stress status. Collected by a swab placed in the mouth.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • positive criteria for Systemic Sclerosis according to the American College of Rheumatology/European League Against Rheumatism

Exclusion Criteria:

  • affection of the vocal apparatus
  • dyspnea at rest
  • oxygen prescription

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02821663

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Contact: Michael Mickel, MD

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Department of Physical Medicine and Rehabilitation, Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Michael Mickel, MD Deptartment of Physical Medicine and Rehabilitation, MUW

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Responsible Party: Michael Mickel, MD, Medical University of Vienna Identifier: NCT02821663     History of Changes
Other Study ID Numbers: SSc-1-MM
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases