Telehealth is increasing popular as a treatment option for people with Parkinson disease (PD). The SpeechVive device is a wearable device that uses the Lombard effect to help patients speak more loudly, slowly, and clearly. This study sought to examine the effectiveness of the device to improve communication in people with PD, delivered over a telehealth modality as compared to in-person, using implementation science design. 66 people with PD were enrolled for 12 weeks with 34 choosing the in-person group and 32 in the telehealth group. Participants were assessed pre-, mid-, and post-treatment. Participants produced continuous speech samples on and off the device at each timepoint. Sound pressure level (SPL), utterance length, pause frequency, and total pause duration were measured. Psychosocial surveys were administered to evaluate the effects of treatment on depression, self-efficacy, and participation. The in-person group increased SPL when wearing the device while the telehealth group did not. Both groups paused less often while wearing the device. Utterance length increased post-treatment for the telehealth group, but not for the in-person group. An increase in communication participation ratings in the telehealth group, but not the in-person group, was the only significant change in the psychosocial metrics. The in-person group showed similar treatment effects as previous studies. The device was not as effective in the telehealth group. One limitation was data loss due to recording issues that impacted the telehealth group more than the in-person group.

SpeechVive devices were provided, without cost, to participants with PD by the company that manufactures and sells them, SpeechVive, Inc., for the 3-month duration of treatment. Jessica Huber is the inventor of the SpeechVive device and served as the Chief Technology Officer and a Board member until the end of June 2021.She also owns shares in SpeechVive, Inc. She is also a member of the Medical Advisory Board for Rock Steady Boxing in Indianapolis, IN and LeAPS for PD in Lafayette, IN Ashleigh Lambert served as the Vice President for Clinical Development for SpeechVive, Inc. until August 2021. Mary Spremulli is a clinical consultant and remote programmer for SpeechVive, Inc. She is the owner of Voice Aerobics, LLC. She is a member of the Medical Advisory Board for the Neuro Challenge Foundation in Sarasota, FL.

NCT02744911

Research reported in this publication was supported by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health under award number R44DC014867. Federal funds in the amount of $277,451 were used to support the larger project from which these data were obtained, covering about 50% of the total costs of the larger project. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We would like to thank the patients with PD and their caregivers who participated in this research.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Purdue University Institutional Review Board gave ethical approval for this work (protocol number 1602017214).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Deidentified data can be obtained upon reasonable request to Jessica Huber (jehuberbuffalo.edu).