Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05091060
Eligibility Criteria:
Inclusion Criteria:
* Subjective tinnitus
* Tonal tinnitus.
* Constant tinnitus on-going at least half the time over at least the past 6 months.
* Willing to abstain from other tinnitus-related treatments except prior hearing aid use throughout the study duration.
* Willing and able to refrain from activities or work involving excessive noise exposure without the use of effective hearing protection throughout study participation.
* 18 years of age or older
* Primary language is English
Exclusion Criteria:
* Objective tinnitus
* Atonal, pulsatile, intermittent, or occasional tinnitus
* Severe or profound hearing loss in one or both ears
* Current or prior surgically removed acoustic neuroma
* Consistent use of any of the following drugs known to cause or increase tinnitus (primarily ototoxins) within the past 30 days:
NSAIDS (motrin, naproxen, relafen, etc) aspirin (exceeding 300mg per day) and other salicylates Lasix and other "loop" diuretics "mycin" antibiotics such as vancomycin quinine and related drugs Chemotherapy agents such as cis-platin
* Acute or chronic vertigo/dizziness
* Ménière's disease
* Prior stapendectomy
* Prior mastoidectomy
* Auditory nerve tumor (acoustic neuroma), current or surgically removed in the past
* Active infection/wound/external trauma to the areas to be treated with the laser
* Medical, physical or other contraindications for, or sensitivity to, light therapy
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05091060
Study Brief:
Protocol Section:
NCT05091060