Clinical trial: The Effects of Respiratory Training on Voice (NCT04710862)

Eligibility criteria:
Inclusion Criteria:

          -  Ages 18 or older

          -  Self-report of general good health other than voice disorder

          -  Self-report of normal pulmonary function

          -  Non-smoker status for at least the last 5 years

          -  English as their primary language to avoid potential linguistically-based differences
             in acoustic measures of voice

          -  Adequate visual acuity (with or without corrective lenses) to read basic graphs and
             print, as determined with visual screening

          -  No evidence of current organic or neurologic laryngeal pathology, as assessed by
             nasolaryngoscopy examination and reviewed by a laryngologist

          -  No prior surgery to the vocal folds

          -  Do not report difficulty with swallowing

          -  Not currently receiving voice therapy or other voice treatment that cannot be
             discontinued

          -  Do not report a bilateral, severe to profound hearing loss

          -  Willingness to be recorded for data collection that is necessary for this study

          -  Have a confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and
             speech-language pathologist

          -  Demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia
             (Cepstral/Spectral Index of Dysphonia) that exceed normative values for the
             participant's age and sex

          -  Based on the nasolaryngoscopy examination and assessment performed by the
             otolaryngologist, show one or more patterns of supraglottic activity that are
             consistent with adducted vocal fold hyperfunction

          -  Show no evidence of abnormal, incomplete vocal fold closure patterns as determined on
             the videostroboscopy assessment (patterns of posterior glottal gaps are normal and
             expected)

          -  Show no evidence of additional neurological voice disorders such as spasmodic
             dysphonia or vocal fold paralysis

          -  Show elevated hyolaryngeal position that exceeds normative expectations as determined
             through quantitative analysis of ultrasonographic laryngeal images measuring change
             from rest to phonation

          -  Demonstrate voice problems that have persisted for ≥2 months

          -  Demonstrate self-reported increase in speaking effort

          -  Show evidence of speech breathing abnormalities relative to accepted normative values

        Exclusion Criteria:

          -  Ages 17 or younger

          -  Self-report of major health problems

          -  Self-report of pulmonary disease such as asthma, chronic obstructive pulmonary
             disease, or emphysema

          -  Current smoker status or prior smoker status within the last 5 years

          -  English not the primary language

          -  Inadequate visual acuity (with corrective lenses if applicable) to read basic graphs
             and print as determined by failing a visual screening

          -  Evidence of current organic or neurologic laryngeal pathology, as assessed by
             nasolaryngoscopy examination and reviewed by a laryngologist

          -  Prior surgery to the vocal folds

          -  Self report of difficulty with swallowing

          -  Currently receiving voice therapy or other voice treatment that cannot be discontinued

          -  Self-report of a bilateral, severe to profound hearing loss

          -  Not willing to be recorded for data collection that is necessary for this study

          -  No confirming diagnosis of Muscle Tension Dysphonia from an otolaryngologist and
             speech-language pathologist

          -  Do not demonstrate quantified auditory-perceptual dysphonia and acoustic dysphonia
             (Cepstral/Spectral Index of Dysphonia) that exceed normative values for the
             participant's age and sex

          -  Based on the nasolaryngoscopy examination and assessment performed by the
             otolaryngologist, do not show one or more patterns of supraglottic activity that are
             consistent with adducted vocal fold hyperfunction

          -  Show evidence of abnormal, incomplete vocal fold closure patterns as determined on the
             videostroboscopy assessment (patterns of posterior glottal gaps are normal and
             expected)

          -  Show evidence of additional neurological voice disorders such as spasmodic dysphonia
             or vocal fold paralysis

          -  Do not show elevated hyolaryngeal position that exceeds normative expectations as
             determined through quantitative analysis of ultrasonographic laryngeal images
             measuring change from rest to phonation

          -  Demonstrate voice problems that have persisted for less than 2 months

          -  Do not demonstrate self-reported increase in speaking effort

          -  Do not show evidence of speech breathing abnormalities relative to accepted normative
             values
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction