None listed
Conditions
Interventions
Intervention1: Tomatis Maestro Device: The Tomatis Maestro headset is a specialised medical device that uses air and bone conduction to deliver processed music, believed to be effective for various
Sponsors
Tomatis Development SA
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Healthy male or female volunteers of 20 to 40 years both inclusive with BMI of 18 35 Kgm2 2. Generally healthy as documented by medical history, physical examination, vital signs, and any available prior medical records. 3. Subjects who have no evidence of medical illness during screening.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Subjects with any ear infection or auditory issues during screening. 2. History of any clinically significant cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological and or any major surgical procedure in the past three months prior to screening. 3. Subjects with a history of epilepsy 4. History of chronic alcoholism, chronic smoking, drugs of abuse. 5. Subjects who cannot listen to music for an hour continuously every day for 14 days. 6. High blood pressure and or asthma. 7. Subject who had participated in any other clinical study during the last 90 days. 8. Subjects who are unable to provide informed consent 9. Subjects who are unable or unwilling to undergo MRI scanning 10. Subjects with metal implants, medical devices such as pacemakers or insulin pumps or tattoos as they cannot undergo MRI scans 11. Subjects who are unable or unwilling to comply with the requirements of the study 12. Pregnant women or Lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the difference between the active Tomatis Maestro device group and the sham control device group in the change from baseline to end-of-study in resting-state functional connectivity, as assessed using Independent Component Analysis (ICA) of resting-state functional magnetic resonance imaging (rs-fMRI) data.Timepoint: Before and after stimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the difference between the active and sham device groups in changes from baseline to end-of-study in resting-state cortical oscillatory activity, as measured by quantitative electroencephalography (qEEG). 2. To evaluate changes in acoustic voice parameters following the intervention, using standardized voice analysis. 3. To evaluate changes in listening function using the Tomatis Fused Listening Test between baseline and end-of-study. 4. To evaluate changes in subjective vitality using the State version of the Subjective Vitality Scale (SVS) between baseline and end-of-study. 5. To evaluate changes in mindful attention and awareness using the Mindful Attention Awareness Scale (MAAS) between baseline and end-of-study. 6. To evaluate the safety and tolerability of the Tomatis Maestro auditory stimulation intervention.Timepoint: Before and after stimulation | — |
Countries
India
Contacts
Public ContactAdarsh Karanth
ClinTrek Research Private Limited
Outcome results
None listed