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A study to test a hands free wearable voice device to help speech in people who have lost their voice after larynx surgery

Design and Development of a Wearable Electrolarynx - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101400
Enrollment
54
Registered
2026-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C329- Malignant neoplasm of larynx, unspecified

Interventions

Intervention1: Wearable electrolarynx device: A non invasive wearable electrolarynx prototype with motion sensor based activation designed to enable hands free speech production. The device is externa

Sponsors

Manipal Academy of Higher Education (MAHE)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults of either sex aged eighteen years and above. The study includes two participant groups. Healthy volunteer group: Adults aged eighteen to eighty years. Healthy volunteers with no history of head and neck surgery laryngeal pathology or neurological or musculoskeletal disorders affecting jaw motion. Normal or corrected vision and hearing. Unimpaired oral motor function able to perform instructed jaw movements and speech tasks. Able to read and comprehend English or Kannada. Willing and able to provide written informed consent and comply with study procedures. Patient group: Adults aged eighteen years and above who have undergone total or partial laryngectomy and have received surgery or radiotherapy as primary treatment. Medically stable with adequate functional vision and hearing. Unimpaired oral motor capabilities assessed by a speech language pathologist sufficient for mouthing words. Able to read and comprehend English or Kannada. Capable of providing informed consent and willing to use the wearable device.

Exclusion criteria

Exclusion criteria: Healthy volunteer group: Current skin conditions at the neck contact site. Known allergy to silicone or strap materials. Acute respiratory illness. Patient group: Significant hearing loss or pre existing hearing or speech impairment that interferes with communication as documented in the chart or reported by family members. Neurological or musculoskeletal disorders affecting jaw motion. Severe cognitive or motor impairments limiting device use. Active infection or unresolved postoperative complications. Prior hypersensitivity to materials used in the device.

Design outcomes

Primary

MeasureTime frame
Speech intelligibility, perceived intelligibility, device usability, user satisfaction and speech activation efficiency during use of the wearable electrolarynx compared to the handheld electrolarynxTimepoint: During and immediately after completion of speech tasks in a single study session

Secondary

MeasureTime frame
Outcome 1: Speech naturalness of electrolaryngeal speech Outcome 2: Overall voice quality in alaryngeal speech including impression, noise, fluency and voicing Outcome 3: Clinical voice quality profile including roughness, breathiness, asthenia and strain Outcome 4: Objective acoustic characteristics including fundamental frequency, signal to noise ratio, intensity and speech rateTimepoint: Immediately after completion of device use in the study session

Countries

India

Contacts

Public ContactDr Madhushankara M

Manipal School of Information Sciences

sawan.msismpl2023@learner.manipal.edu8123015196

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026