Search Bar & Filters

Found 1 Actively Recruiting clinical trials

U

Actively Recruiting

Researchers are evaluating whether Transcutaneous Auricular Neurostimulation (tAN4), a non-invasive device delivering small electrical stimulations to the Vagus and Trigeminal nerves, is effective in managing alcohol withdrawal syndrome. This study involves adults aged 18 to 65 who are entering inpatient treatment for alcohol withdrawal. The research aims to see if tAN4 can reduce withdrawal symptoms and the need for comfort medications over a five-day period. The study will also collect data on alcohol craving, mood, sleep, stress response, and physical activity. Participants will be randomly assigned to one of two groups: the active group will receive treatment with the Sparrow4 Link tAN4 device along with usual care, while the control group will receive usual care alone (sham tAN4). The Sparrow Link device uses earpieces to deliver electrical stimulation and is based on an FDA-cleared system. Data will be collected four times daily for five days using ecological momentary assessment and a fitness tracker. Daily assessments will include the Clinical Institute Withdrawal Assessment Scale, Revised (CIWA-Ar). During the study, participants will be monitored closely with frequent assessments of withdrawal severity, medication use, alcohol craving, mood, sleep, and physical activity. Researchers will track comfort medication use and withdrawal scores from baseline through day five. Participants must be available and willing to comply with study procedures throughout the five-day period. Safety monitoring will exclude those with certain medical conditions or devices that contraindicate tAN4 use.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location
Clinical trials in Wernersville | DecenTrialz