NCT03999606

Brief Summary

Most adults experience some degree of hearing loss by age 60. Hearing aids can improve some aspects of peripheral hearing but the loss of the ability to clearly perceive speech in noisy environments remains to be a significant deficit and often reduces life quality in older adults. Long-term music training has been shown to enhance auditory processing and specifically benefit speech-in-noise perception. It is not clear however whether short-term participation in a musically engaged activity can benefit such abilities in older adults. The proposed study aims to investigate whether short-term participation in a weekly community choir can improve speech in noise perception and its neural substrates as measured by sensory auditory evoked potentials (ERPs) to speech stimuli in older adults with mild to moderate subjective hearing loss. Sixty participants, ages 50-65, will be recruited to partake in this study and will be randomly assigned to two groups: participants in the experimental group will join a weekly remote choir on an on-line platform (Zoom), for ten weeks, directed by a professionally trained conductor from USC Department of Choral Music. The group practice will be accompanied by individual singing lessons (online or CDs) for home practice. Participants in the control group will be provided with weekly remote mindfulness lessons also on an on-line platform. All participants will be assessed remotely pre and post intervention, with behavioral measures of speech in noise perception and probes assessing emotional well-being and life satisfaction. Changes in auditory measures and their neural correlates and overall quality of life will be compared between the groups. The findings from this study can provide preliminary data to support a larger study on the impact of music engagement in improving the lives of older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

June 24, 2019

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Enhanced speech in noise perception

    The effects of age on participants' ability to detect speech in noise will be assessed using the QuickSIN test (Speech-In-Noise; Version 1.3).

    15 weeks

  • Enhanced speech in noise perception

    EEG data will be collected using the speech syllable /da/, spoken in isolation by an American female. The stimulus will be presented in four conditions, in quiet and in presence of an 8-talker babble noise at three SNRs (10, 5 and 0 dB), presented in a random order for each participant, with an inter-stimulus interval of 1000 ms.

    15 weeks

Secondary Outcomes (1)

  • Psychological Well-Being

    15 weeks

Study Arms (2)

Mindfulness Training

ACTIVE COMPARATOR

Participants in the control group will be assigned to a online based mindfulness training.

Behavioral: Music Training - Choir participation

Music Training

EXPERIMENTAL

Participants in the experimental group will be assigned to a online based choir program.

Behavioral: Music Training - Choir participation

Interventions

Sixty participants, ages 50-65, will be recruited to partake in this study and will be randomly assigned to two groups: participants in the experimental group will join a weekly on-line choir via Zoom, for ten weeks, directed by a professionally trained conductor from USC Department of Choral Music. The group practice will be accompanied by individual singing lessons (online or CDs) for home practice. Participants in the control group will be provided with weekly remote mindfulness lessons also on an online platform.

Mindfulness TrainingMusic Training

Eligibility Criteria

Age50 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Native English speaker with experience of subjective hearing loss;
  • Normal IQs (standard score of \>85) as measured by the two-subtest Abbreviated Wechsler's Adult Scale of Intelligence.

You may not qualify if:

  • Use of prescribed hearing aids;
  • Sever hearing loss (thresholds of 60 and 95 dB)
  • Current diagnosis of neurological or psychiatric disorders
  • Impaired cognitive function (all participants will be screened with the Montreal Cognitive Assessment Battery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain and Creativity Institute

Los Angeles, California, 90089, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor of Psychology

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 26, 2019

Study Start

October 1, 2020

Primary Completion

January 30, 2021

Study Completion

March 30, 2021

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations