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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.
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Characterizing the Impact of Presbyphonia on Social Interaction

Recrutando
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O estudo clínico NCT06441136 é um ensaio intervencionista para Presbyphonia. Seu status atual é: recrutando. O estudo começou em 10 de janeiro de 2025 e pretende incluir 25 participantes. Coordenado por Matthew R. Hoffman e deve ser concluído em 31 de agosto de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 17 de julho de 2025.
Resumo
The purpose of this study is to determine if presbyphonia, or voice disorder caused by age-related change in the larynx, is associated with change in social interaction. This proposal investigates the impact of voice impairment in older adults on social interaction, loneliness, social disconnectedness, and depression. A series of questionnaires, voice assessments, and interviews will be performed to improve our understanding of how voice disorders affect older adults and how treatment of voice impairment with voice therapy may improve quality of life.
Descrição detalhada
During the study visit, all subjects (including the control group) will be given ten questionnaires asking them to rate their loneliness and quality of life in relation to the changes in their voice. All participants will undergo audiometry to assess hearing (with hearing aids if used at home). If they do not pass the hearing test, they will be screened out of the study.

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.

Título oficial

Characterizing the Impact of Presbyphonia on Social Interaction

Condições
Presbyphonia
Publicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:
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Outros IDs do estudo
  • 202307188
Número NCT
Data de início (real)
2025-01-10
Última atualização postada
2025-07-17
Data de conclusão (estimada)
2026-08-31
Inscrição (estimada)
25
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
voice therapy
aging voice
voice disorder
speech
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Critérios de elegibilidade

Idades elegíveis
Adulto mais velho
Idade mínima
65 Years
Sexos elegíveis
Todos
  • 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
Matthew R. Hoffman logoMatthew R. Hoffman
Responsável pelo estudo
Matthew R. Hoffman, Patrocinador-Investigador, Assistant Professor, University of Iowa
Contato central do estudo
Contato: Matthew R Hoffman, MD, PhD, 319-356-2201, [email protected]
Contato: Emma L Thayer, BS, 319-678-7518, [email protected]
1 Locais do estudo em 1 países

Iowa

University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States
Emma L Thayer, BS, Contato, 515-371-7676, [email protected]
Recrutando