Clinical testing of a low cost speech device for throat cancer patients
Phase 1
- Conditions
- Health Condition 1: C320- Malignant neoplasm of glottisHealth Condition 2: C329- Malignant neoplasm of larynx, unspecifiedHealth Condition 3: C328- Malignant neoplasm of overlappingsites of larynxHealth Condition 4: C322- Malignant neoplasm of subglottisHealth Condition 5: C321- Malignant neoplasm of supraglottis
- Registration Number
- CTRI/2022/02/040558
- Lead Sponsor
- Department of Science and Technology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion Criteria:
1.For Voice prosthesis: Tracheoesophageal speakers (minimum 1-month post-surgery)
2.For Lary Tube: Individuals post total Laryngectomy (Minimum 1 month post-surgery)
Exclusion Criteria
Exclusion Criteria:
1.Individuals above 80 years of age
2.Individuals with dexterity issues
3.Individuals with vision problems
4.History of any neurological, psychiatric, or psychological ailments
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Clinical outcomes <br/ ><br>a.Voice <br/ ><br>MPD <br/ ><br>Pitch <br/ ><br>Loudness <br/ ><br>Voice quality <br/ ><br> <br/ ><br>b.speech <br/ ><br>Intelligibility rating scale <br/ ><br>Counts per breath <br/ ><br>c.swallowing <br/ ><br>Difficulty with food consistencies <br/ ><br>Feeling of food getting stuck <br/ ><br>AspirationTimepoint: 1: With commercial voice prosthesis <br/ ><br>2: immediately post fitting of indigenous voice prosthesis <br/ ><br>3: After 15 days of use of indigenous voice prosthesis <br/ ><br>4: After 1 month of use of indigenous voice prosthesis
- Secondary Outcome Measures
Name Time Method 1.Device related outcomes <br/ ><br>Type of voice prosthesis-Dimensions <br/ ><br>Cost of Device <br/ ><br>Durability (duration of usage without leakage related issues) <br/ ><br>Ease of fitting <br/ ><br>Leakage issues <br/ ><br>Discoloration /damage <br/ ><br> <br/ ><br>Timepoint: <br/ ><br>1: With commercial voice prosthesis <br/ ><br>2: immediately post fitting of indigenous voice prosthesis <br/ ><br>3: After 15 days of use of indigenous voice prosthesis <br/ ><br>4: After 1 month of use of indigenous voice prosthesis <br/ ><br>