Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT01255735
Eligibility Criteria:
Inclusion criteria
1. Eligibility is contingent on the presence of apparent vocal fold nodules, which are defined as bilateral, localized, benign, superficial growths with protrusion on the medial surface of the true vocal folds at the junction of their anterior and middle thirds. This examination is based on video-stroboscopic examination, or, in rare cases, on operative microsuspension laryngoscopy. In addition, strict exclusion criteria are applied toward excluding masses that are not nodules. Defining characteristics for these inclusion criteria are based upon the evaluations of three senior otolaryngologists of each participant's exam. Children evaluated by the senior otolaryngologist at each institution suspected to have vocal fold nodules are candidates for inclusion to this study. Patient de-identified images of the stroboscopy are reviewed by each of the other two laryngologists; only those children with confirmed vocal fold nodules by the all three senior otolaryngologists will be considered for entry into this study.
2. Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range.
3. Voice-related quality of life must be affected to the extent that baseline PVRQOL scores are \<87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores \<87.5 represent worse than average scores among children diagnosed with vocal fold nodules.
4. Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature.
5. Hearing in better ear of 35 dB or better.
6. Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework.
7. Vocal fold nodules are a pathology that predominantly affects males. A number of studies and the databases utilized to track this pathology at the clinical sites indicate that the male: female ratio is approximately 7:3. Given this background, the enrollment plan for the current investigation will seek to have a 30% female representation of the patients enrolled in this study to ensure appropriate gender representation. Additionally, patients with a diagnosis of pediatric vocal fold nodules predominantly are found in Caucasian populations. However, in accordance with the National Institute of Health Revitalization Act of 1993 the inclusion of minorities in this proposal will be targeted to the representation of minorities in the greater Boston, Philadelphia and Milwaukee metropolitan regions.
Exclusion criteria
1. Children with non-standard nodules or masses that are not unequivocally nodules are excluded, including those with irregular epithelium, concern for malignancy requiring biopsy, rapid growth pattern, airway obstruction requiring urgent or operative intervention, and prior laryngeal surgery. Furthermore, since there are several lesions that can present as bilateral true vocal fold masses (such as unilateral cysts or polyps with contralateral fibrovascular reaction, contact granulomas, and Reinke's edema), masses with the following characteristics will be excluded: a) yellow or blue color suggestive of a mucous- or fluid-filled component, b) pink friable lesions at the posterior aspect of the true vocal folds, c) watery edematous expansion without a distinct protrusive mass. Defining characteristics for these exclusion criteria are determined and corroborated by the evaluations of three senior otolaryngologists of each participant's videostroboscopic exam. This examination is based on video-stroboscopy, or, in rare cases, on operative microsuspension laryngoscopy. The video images will be placed on a password-protected server to which all three senior investigators will have access; these video images will not contain any patient identifying information but rather a study number that will be assigned to each participant. In addition, strict inclusion criteria are applied toward excluding masses that are not nodules.
2. Children who have previously received any form of speech therapy targeting voice and/or resonance with the exception of articulation or speech therapy.
3. Children for whom voice therapy protocols will be problematic are excluded: developmental delay, cognitive disorder, behavioral disorder, neurologic disorder, articulation disorder, phonological disorder, language disorder, expressive and/or receptive language delay, specific language impairment, central auditory processing disorder, fluency disorder, prior knowledge of voice therapy principles through previous interventions (with the exception of articulation or speech therapy), and inability to commit to at least 12 weeks of therapy as determined and evaluated by the treating speech language pathologist and confirmed by consensus of all three PIs.
4. Children whose caregivers cannot complete the primary endpoint are excluded: non-English speaking as the PVRQOL instrument is administered in English, and those unable to commit to the 3-month treatment and follow-up schedule.
5. Children whose caregivers are not willing to commit up to 3 hours per week to vocal therapy including therapy sessions and homework for up to 12 weeks.
6. Children who cannot tolerate a conscious video-stroboscopic examination and whose parents feel that the diagnostic information gained by a planned examination under anesthesia is not valuable for the severity of presenting symptoms are excluded.
7. Children with significant confounders of voice-related quality of life are excluded: vocal fold paralysis, neurologic disorder of the larynx (dystonias, tics, tremors, etc), ongoing acute upper respiratory tract infection (defined by at least 2 of the following: sneezing, coughing, nasal congestion, runny nose, or temperature greater than 100.4° F (38.0° C), and untreated or unsuccessfully treated allergic rhinitis/post nasal drip.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT01255735
Study Brief:
Protocol Section:
NCT01255735