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Trial Outcomes & Findings for Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals (NCT NCT00787189)

NCT ID: NCT00787189

Last Updated: 2021-05-28

Results Overview

Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

baseline and one week

Results posted on

2021-05-28

Participant Flow

40 subjects (80 ears) were recruited across two hearing aid and evaluation test sites from May, 2007 to October, 2008.

4 subjects (8 ears) were disqualified because the word recognition score recorded for study qualification purposes exceeded the upper inclusive limit of 86% words correct. 4 subjects (8 ears) were disqualified because the subject's primary spoken language was not English, which was also a study exclusion criteria.

Participant milestones

Participant milestones
Measure
Active
Active laser device
Control
Placebo laser device
Overall Study
STARTED
32
32
Overall Study
COMPLETED
30
30
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Active
Active laser device
Control
Placebo laser device
Overall Study
Lost to Follow-up
2
2

Baseline Characteristics

Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active
n=32 Participants
Active laser device
Control
n=32 Participants
Placebo laser device
Total
n=64 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
0 Participants
n=7 Participants
6 Participants
n=5 Participants
Age, Categorical
>=65 years
26 Participants
n=5 Participants
32 Participants
n=7 Participants
58 Participants
n=5 Participants
Age, Continuous
78.94 years
STANDARD_DEVIATION 5.92 • n=5 Participants
76.00 years
STANDARD_DEVIATION 9.86 • n=7 Participants
77.47 years
STANDARD_DEVIATION 8.265 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
18 Participants
n=7 Participants
28 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
14 Participants
n=7 Participants
36 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline and one week

Participants were asked to repeat 50 words presented one at a time through headphones to each ear separately at a comfortable listening level to the participant. The 50 words were from a phonetically-balanced list of monosyllabic words called the Central Institute for the Deaf (CID) W-22 lists. For each ear, each word repeated correctly was scored '1'. The total number correct for each ear was summed and multiplied by 2 to attain the percent of total words repeated correctly for each ear. The change in this percent from baseline to one week after study treatment was referenced against a chart. If the change was equal to or greater than the corresponding value in the chart, the participant was considered to have a successful study outcome.

Outcome measures

Outcome measures
Measure
Active
n=32 Participants
Active laser device
Control
n=32 Participants
Placebo laser device
Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a Reference Chart.
15 participants
2 participants

Adverse Events

Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elvira Walls, Clinical Consultant

Regulatory Insight, Inc.

Phone: 615-712-9743

Results disclosure agreements

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