IA Trial Radar | ||
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O estudo clínico NCT06441136 para Presbyphonia está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Characterizing the Impact of Presbyphonia on Social Interaction
Participants will then provide a required voice sample using sustained vowels for 3-5 seconds 5 times each, repeating six standard sentences, and 20 seconds of natural conversational speech. Using this voice recording, the following assessments and measurements will be obtained: CAPE-V rating (Consensus auditory perceptual evaluation of voice), Cepstral peak prominence (measurement of dysphonia), fundamental frequency, signal-to-noise ratio, and voice type components (captures breathiness).
Subjects will then be asked to produce a train of /pi pi pi/ at a comfortable pitch and loudness into a mask with an intra-oral mouthpiece to record both pressure and airflow. Five trials will be performed. The following measurements will be obtained: mean flow rate, subglottal pressure, and vocal efficiency.
Subjects will then undergo an awake videostroboscopy using a small flexible camera passed through the nose to view the vocal folds. During this procedure, the nose is anesthetized and the subject is asked to produce sustained vowels for 3-5 seconds. This part of the study takes about 2 minutes to complete. The parameters to be measured for this are: bowing index of the vocal folds and normalized glottal gap.
For the second part of this study, subjects from the presbyphonia population only will be recruited to participate in the phonation resistance training exercises or PhoRTE voice therapy. Prior to therapy, for two weeks, participants will take pictures when their voice disorder may be affecting them or ability to socialize. Brief journal entry will be completed. Photos will be collected, printed, and used as memory recall tool for a pre-treatment semi-structured interview. Interviews will be conducted, approximately 45-60 minutes induration. Both online and in-person options will be available to facilitate participation. An interview guide will include questions designed to assess participants' perception of voice and how voice affects social participation.
Subjects will then complete PhoRTE therapy. Participants perform 5 vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks.
Following therapy, participants will participate in 60-75-minute semi-structured small group interviews approximately 3 months after voice therapy. Interviews will address experience with voice therapy, and any changes after voice therapy.
Characterizing the Impact of Presbyphonia on Social Interaction
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aging voice
voice disorder
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| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalPhonation Resistance Training Exercises (PhoRTE) Voice Therapy Program PhoRTE is a voice therapy program administered by a speech language pathologist for participants with presbyphonia. During sessions, participants perform five vocal exercises at individualized target vocal intensity. Goals of therapy are to increase muscular workload on vocal mechanism and target the respiratory and laryngeal muscular deficits that result from aging. Participants practice 6 days per week at home and meet with speech pathologist weekly for 4 weeks. | Phorte Program Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises. University of California Los Angeles (UCLA) Loneliness Scale A questionnaire measuring levels of loneliness. Social Disconnectedness Scale A questionnaire that asks about social network size and the frequency of social activities attended. Patient Health Questionnaire 9 A questionnaire measuring levels of depression. Aging Voice Index A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults. The Edmonton Frail Scale A questionnaire that measures frailty levels. Vocal Effort Scale A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice. Avaliação Cognitiva de Montreal A screening tool used to test for cognitive impairment. Voice Handicap INDEX-10 A questionnaire used to measure quality of life impact of dysphonia. Voice Problem Impact Scales A 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life. Cough Severity Index A 10 question survey asking to rate severity of cough. Laringoscopia Nose is anesthetized and a flexible endoscope is passed to visualize the larynx at rest and during sustained vowel production (/i/) for 3-5 seconds. This will be used to measure bowing index and normalized glottal gap of the vocal folds. Acoustic, Perceptual, and Aerodynamic Assessments Participants will complete voice recording tasks including sustained vowel production, six standard sentences, and 20 seconds of natural conversational speech. This will be used to measure CAPE-V rating, Cepstral peak prominence, fundamental frequency, signal-to-noise ratio, voice type components, mean flow rate, subglottal pressure, and vocal efficiency. |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
The Effect on Loneliness with the PhoRTE Voice Therapy Program | Loneliness will be measured using the University of California - Los Angeles (UCLA) Loneliness Scale questionnaire at baseline and at the end of the 4-week PhoRTE program. The UCLA Loneliness Scale is a 20-item scale with each item rated on a 4-point Likert scale (ranging from 1, "never," to 4, "often") and the total score can range from 20 to 80, with higher scores indicating greater feelings of loneliness. | Baseline and at 3 months |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
The Effect on Social Disconnectedness with the PhoRTE Voice Therapy Program | Social disconnectedness will be measured using the Social Disconnectedness Scale questionnaire at baseline and at the end of the 4 week PhoRTE program. The Social Disconnectedness Scale is based on a 15-item scale with each item rated on their own scale depending on the question asked (ex: ranging from 0, "never" to 7, "several times a week" or indicating number of individuals in a social network). The total score can range from 2 to 72, with lower scores indicating greater levels of social disconnectedness. | Baseline and at 3 months |
The Effect on Depression with the PhoRTE Voice Therapy Program | Levels of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and at the end of the 4 week PhoRTE program. The PHQ-9 is a 9-item scale with each item rated on a scale (ranging from 0, "not at all," to 3, "nearly every day") and the total score can range from 0-27 with higher scores indicating greater feelings of depression. | Baseline and at 3 months |
- Diagnosis of presbyphonia with findings of presbylaryngis on videostroboscopy, with findings of bilateral true vocal fold atrophy and normal vocal fold motion bilaterally
- Able to complete all questionnaires and voice assessment tasks
- Normal to mild hearing loss in aided condition (with hearing aids)
- Liquid dysphagia or pneumonia in the last year
- Vocal fold lesion/scar/motion impairment
- Neurologic disorder affecting the voice
- Montreal cognitive assessment score <26 or <25 if 12 or fewer years of formal education
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