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A clinical trial to study the effect of auditory training in improving cognition in individuals with mild cognitive impairment.

Phase 1
Conditions
Health Condition 1: G311- Senile degeneration of brain, notelsewhere classified
Registration Number
CTRI/2023/06/054277
Lead Sponsor
eelavathi T
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Phase I & II: Study Group

Patients with a diagnosis of Mild Cognitive Impairment as per the National Institute of Aging Alzheimers Association NIA AA

MoCA scores 19 to 25

Audiometric thresholds less than 40 dBHL in 250 500 and 1000 Hz

Participants with normal middle ear function which will be confirmed using Interacoustics middle ear analyzer

Education level greater than 8th grade

Phase I- Control Group

Age and hearing-matched controls

MoCA scores greater than 25

Educational level greater than 8th grade.

Exclusion Criteria

Both Groups:

Patients undergoing cognitive or behavioural interventions to improve cognition

Presence or history of other neurological disorders like stroke epilepsy brain injury or tumor based on their medical history

Presence of psychological illness based on Patient Health Questionnaire PHQ 9

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Cognition: <br/ ><br>i.The ACE- III- Total scores <br/ ><br>ii.Mental rotation test: Reaction time in milliseconds & response accuracy <br/ ><br>iii.Digit span test: Length of longest digits recalled- forward & backward <br/ ><br>iv.Trail Making test: Response time in seconds <br/ ><br>v.Attention Network Test: Total scores <br/ ><br>Timepoint: 4-time points- Baseline, four weeks after treatment, Post-treatment (8 weeks), One-month follow-up post-treatment.
Secondary Outcome Measures
NameTimeMethod
i.DDT- Right ear scores, left ear scores & total correct scores. <br/ ><br>ii.QuickSiN- SNR loss in dB <br/ ><br>iii.Gap detection threshold at all frequencies. <br/ ><br>iv.TFS-AF- Highest frequency as threshold. <br/ ><br>v.Frequency Modulation Difference Limen- Modulation rate (Hz) <br/ ><br>vi.Temporal Modulation Transfer Function- a graph of amplitude modulation as function of frequencyTimepoint: 4-time points- Baseline, four weeks after treatment, Post-treatment (8 weeks), One-month follow-up post-treatment.;Neurophysiological changes: <br/ ><br>EEG Connectivity measures (Phase Locking Value & Coherence)Timepoint: 2- time points, Baseline & post- treatment (8 weeks)
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