Trial Outcomes & Findings for Clinical Applications for Time-Compressed Speech Tests (NCT NCT00371839)

NCT ID: NCT00371839

Last Updated: 2014-12-08

Results Overview

Measure speech perception for sentences in background noise

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: one year
• Results posted on: 2014-12-08

Participant Flow

Veterans from 50 to 75 years of age with hearing loss, not hearing aid wearers

After audiometric thresholds were tested, subjects were assigned to one of three groups based on their pure tone averages (PTA) of thresholds at 500, 1000, 2000, and 4000 Hz. The groups were: Mild (PTAs of 20-39 decibels (dB) hearing level (HL) Moderate (PTAs of 40-49 dB HL) Moderate-Severe (PTAs over 50 dB HL)

Participant milestones

Measure	Mild HL Average hearing loss between 20 and 39 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	Mod HL Average hearing loss between 40 and 49 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	ModSev HL Average hearing loss greater than 50 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception
Overall Study STARTED	49	20	9
Overall Study COMPLETED	32	13	7
Overall Study NOT COMPLETED	17	7	2

Reasons for withdrawal

Measure	Mild HL Average hearing loss between 20 and 39 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	Mod HL Average hearing loss between 40 and 49 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	ModSev HL Average hearing loss greater than 50 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception
Overall Study Death	4	0	0
Overall Study Withdrawal by Subject	7	4	0
Overall Study Lost to Follow-up	6	3	2

Baseline Characteristics

Clinical Applications for Time-Compressed Speech Tests

Baseline characteristics by cohort

Measure	Mild HL n=32 Participants Average hearing loss between 20 and 39 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	Mod HL n=13 Participants Average hearing loss between 40 and 49 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	ModSev HL n=7 Participants Average hearing loss greater than 50 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	Total n=52 Participants Total of all reporting groups
Age, Continuous	59.9 years STANDARD_DEVIATION 6.8 • n=5 Participants	62.7 years STANDARD_DEVIATION 7.0 • n=7 Participants	65.1 years STANDARD_DEVIATION 5.1 • n=5 Participants	61.7 years STANDARD_DEVIATION 5.1 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	49 Participants n=4 Participants

PRIMARY outcome

Timeframe: one year

Measure speech perception for sentences in background noise

Outcome measures

Measure	Mild HL n=32 Participants Average hearing loss between 20 and 39 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	Mod HL n=13 Participants Average hearing loss between 40 and 49 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception	ModSev HL n=7 Participants Average hearing loss greater than 50 decibels hearing level (HL) Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception
Ability to Understand Speech in Noise Background	84 Percent correct of 100 presented words Standard Deviation 4.0	78 Percent correct of 100 presented words Standard Deviation 7.0	47 Percent correct of 100 presented words Standard Deviation 9.0

Adverse Events

Arm 1

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=69 participants at risk Study performance on cognitive and hearing tests Audiological Evaluation: Tests of hearing, cognition, and speech perception
General disorders Death or terminal illness	8.7% 6/69 9 subjects were lost to followup and could not be contacted for continued data collection

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marjorie R. Leek

Portland VAMC

Phone: (909)825-7084

Email: Marjorie.Leek@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place