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临床试验/NCT06540989
NCT06540989招募中早期 1 期

Understand Me for Life: Using Noise-augmented Automatic Speech Recognition to Improve Intelligibility in Parkinson's Disease

Teachers College, Columbia University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
入组人数
42
试验地点
1
主要终点
Intelligibility

研究概览

简要总结

The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinson's disease. The main questions the investigators will address are:

Does noise-augmented feedback lead to increased intelligibility, as measured by transcription accuracy scores?

Does a self-managed speech protocol lead to increased social participation, as measured by the Communicative Participation Item Bank and the Communicative Effectiveness Index questionnaires?

Participants will:

Receive 2-4 initial speech assessments in-person in our lab. Engage in speech treatment sessions at home using their phone and computer four days a week for four weeks. Four of those sessions will be directly monitored online by a speech-language pathologist. The rest of the sessions are completed by the participant.

Come to the lab for two post-treatment assessments following completion of treatment.

Come to the lab six months after treatment completion for an additional assessment.

详细描述

The goal of this clinical trial is to learn whether noise-augmented feedback using automatic speech recognition improves intelligibility and social participation in individuals with Parkinson's disease.

Data collection will be face-to-face at a convenient time for participants. The screening and assessment sessions will take place in the Communication, Technology, and Language Diversity Lab (Room 952a), on the 9th floor of the 528 Building at Teachers College, Columbia University (525W 120th St, New York, NY 10027).

Treatment sessions will be conducted independently by the participant in the participant's home. Four out of the 16 treatment sessions will be supervised online (via Zoom) by a licensed speech and language pathologist.

The study involves 5-7 assessment sessions (including one 6-month follow-up) and 16 treatment sessions ( = 1 month). Each participant is expected to be involved in the study for 7-8 months.

Participants will first attend a screening session to confirm eligibility, which will involve a hearing screening, a brief cognitive screening, and a brief depression screening. If the screening is successful, participants will complete two or four assessment sessions before initiation of the treatment protocol (the number of assessment sessions depends on their group allocation: immediate treatment or deferred/delayed treatment).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will qualify for the study if:
  • They are 50-80 years old,
  • They have a medical diagnosis of PD,
  • They are within stages I-IV of Hoehn & Yahr Scale,
  • Their antiparkinsonian medication schedule is stable,
  • They present with mild to moderate dysarthria,
  • They score ≥ 25 in the MMSE,
  • They score ≤ 24 in the BDI-III.

排除标准

  • Participants will be excluded from the study if they:
  • Present with atypical parkinsonism at the time of screening (or other neurological condition),
  • Underwent neurosurgery treatment (DBS),
  • Received intensive voice-focused treatment less than three months prior to their involvement in the current study,
  • Present with any speech or voice pathology that is unrelated to PD.

结局指标

主要结局

Intelligibility

时间窗: 3 years

Transcription accuracy (% words correctly understood by listeners)

次要结局

  • Social participation(7-8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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