An interventional study of PhoRTE Program and University of California Los Angeles (UCLA) Loneliness Scale in Presbyphonia, sponsored by Matthew R. Hoffman. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Matthew R. Hoffman · Not applicable, Interventional, and Treatment
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.
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.
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's planned enrollment of 25 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →This is the only study on the registry with Matthew R. Hoffman as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: PhoRTE Program · Other: University of California Los Angeles (UCLA) Loneliness Scale · Other: Social Disconnectedness Scale · Other: Patient Health Questionnaire 9 · Other: Aging Voice Index · Other: The Edmonton Frail Scale · Other: Vocal Effort Scale · Other: Montreal Cognitive Assessment · Other: Voice Handicap Index-10 · Other: Voice Problem Impact Scales · Other: Cough Severity Index · Procedure: Laryngoscopy · Other: Acoustic, perceptual, and aerodynamic assessments
Speech therapy program guided by a speech language pathologist. This program includes in person or virtual visits and at home exercises.
Also known as: Speech Therapy Program
A questionnaire measuring levels of loneliness.
Also known as: UCLA Loneliness Scale
A questionnaire that asks about social network size and the frequency of social activities attended.
A questionnaire measuring levels of depression.
Also known as: PHQ-9
A questionnaire of patient-reported voice outcome measures designed to capture the quality of life impact of dysphonia in older adults.
A questionnaire that measures frailty levels.
A picture based questionnaire scale that asks the subject to rate their perceived effort when using their voice.
A screening tool used to test for cognitive impairment.
Also known as: MOCA
A questionnaire used to measure quality of life impact of dysphonia.
Also known as: VHI-10
A 4 question survey that captures impact of voice on four domains - work/daily activities, social life, home, and overall quality of life.
Also known as: VPIS
A 10 question survey asking to rate severity of cough.
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.
Also known as: Flexible transnasal videostroboscopy
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.
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.
Time frame: Baseline and at 3 months
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.
Time frame: 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.
Time frame: Baseline and at 3 months
Plan to share: Yes — Any data or resources, shared upon request, will be de-identified and released only after appropriate data sharing agreements are completed by the relevant parties. Users must agree to the conditions of use governing access to the public release data. This includes restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, proper acknowledgement of the data resource, information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: after study completion
Access criteria: email principal investigator a non-disclosure and/or data usage agreement will most likely be required
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