Glottic Insufficiency
Conditions
Brief summary
Unilateral vocal cord paralysis (UVCP) is a clinical condition and often leads to glottic insufficiency. The presence of glottic insufficiency can result in poor pronunciation quality, vocal fatigue, shortness of breath with speaking, and in some cases, it could lead to unable to pronounce, dysphagia and aspiration, severely decreasing quality of life for its victims. This study is carried out to explore the short-term and long-term efficacy of the functional collagen scaffold in guiding laryngeal soft tissue regeneration.
Interventions
Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
BIOLOGICALAutologous adipose cell transplantation
Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope
Sponsors
Peking Union Medical College
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age of 18-65 years old, male or female 2. Unilateral vocal cord injury and poor closure of the glottis 3. Disease course was more than 1 year 4. At least two GRBAS scores reach 2 points or more 5. The subjects have read and fully understood the research notes, signed informed consent
Exclusion criteria
1. Over speaking professionals, such as teachers, shop assistants 2. With vital organ dysfunction, such as heart, lung, liver or kidney 3. With malignant tumors 4. Pregnant or lactating women, or in preconception period 5. History of drug allergy 6. Difficult to be followed-up or cooperate long-termly 7. Participated in other clinical trials in the last 3 months 8. With severe progressive diseases 9. Alcoholics or drug addicts 10. Unable to execute clinical study protocol due to severe mental disorders or lingual barriers 11. With inevitable circumstances of voice damage 12. Any other unsuitable conditions for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GRBAS scale | 1 week after intervention | Auditory perceptual evaluation was assessed with a GRBAS scale, in which the voice properties, such as the grade of the severity of dysphonia (G), roughness (R), breathiness (B), asthenia (A), and strain (S), are scored on a four-point scale: 0 = normal, 1 = slight deviance, 2 = moderate deviance, and 3 = severe deviance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jitter | 1 week, 1, 3, 6, 9, 12 month after intervention | Acoustic voice analysis parameter. Jitter is for short and middle term pitch perturbation analysis |
| Shimmer | 1 week, 1, 3, 6, 9, 12 month after intervention | Acoustic voice analysis parameter. Shimmer is for short and middle term amplitude perturbation analysis |
| Normalized noise energy (NNE) | 1 week, 1, 3, 6, 9, 12 month after intervention | Acoustic voice analysis parameter. Normalized Noise Energy (NNE) is automatically computed from the voice signals using an adaptive comb filtering method performed in the frequency domain |
| Voice handicap index (VHI) scale | 1 week, 1, 3, 6, 9, 12 month after intervention | The Voice Handicap Index (VHI) is a 30-item test divided into 3 subscales that measure the functional, physical and emotional features of the disability caused by voice impairment was used for patient self-assessment. The subscale scores ranged from 0 to 40, and the total ranged from 0 to 120, with a higher score indicating a greater degree of disability |
| Physical status of vocal cords | 1 week, 1, 3, 6, 9, 12, 24 month after intervention | The morphology of vocal cords (thin or fat, smooth or rough, plump or atrophy), motor function of vocal cords (normal, limited or fixed) and glottic closure (yes or no) were observed by fiber laryngoscopy |
| Volume of vocal cords | Baseline, 1 year, 2 year after intervention | The volume of vocal cords was evaluated by Computed tomography (CT) |
| Maximum phonation time (MPT) | 1 week, 1, 3, 6, 9, 12 month after intervention | Acoustic voice analysis parameter. Maximum phonation time (MPT) represents the maximum time that an individual can sustain the vowel /a/ at a comfortable pitch and loudness |
Countries
China
Contacts
Primary ContactZhifeng Xiao, Ph.D
Backup ContactSufang Han, Ph.D
Outcome results
None listed