Trial Outcomes & Findings for Concussion Device Audiological Measures (NCT NCT02262507)

Results Overview

Number of participants undergoing acoustic reflectance with and without the compression collar

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

410 participants

Primary outcome timeframe

within single day

Results posted on

2020-12-09

Participant milestones
Measure	Device Wearing All subjects who meet the study criteria and volunteer to participate will be included in the study. Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.
Overall Study STARTED	410
Overall Study COMPLETED	410
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Concussion Device Audiological Measures

Baseline characteristics by cohort
Measure	Device Wearing n=410 Participants All subjects who meet the study criteria and volunteer to participate will be included in the study. Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins
Age, Categorical <=18 years	335 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	18.5 years n=5 Participants
Sex: Female, Male Female	251 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants
Region of Enrollment United States	410 participants n=5 Participants

Timeframe: within single day

Population: Subjects

Number of participants undergoing acoustic reflectance with and without the compression collar

Outcome measures
Measure	Device Wearing n=410 Participants All subjects who meet the study criteria and volunteer to participate will be included in the study. Q Collar: Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.	Non Device Wearing n=410 Participants same subjects tested while not wearing the device
Number of Participants Undergoing Acoustic Reflectance	410 participants	410 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Cincinnati Childrens Hospital Sports Medicine

Phone: 513-636-0249