Clinical trials

4

Search and review clinical trials. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Noninvasive Therapy for Tinnitus

The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Restorear Devices LLCUpdated: Jan 12, 2026Locations: 1
Eligibility criteria

Adults aged 18 years or older at the time of signing the consent form [+3]

Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7) [+14]

Status: Recruiting

External Therapy for Tinnitus Management

The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are: 1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change. 2. Ascertain the comfort and acceptability of the hypothermia device and therapy. Participants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving therapy to those from a control group.

Participants needed: 80
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: Restorear Devices LLCUpdated: Sep 17, 2025Locations: 1
Eligibility criteria

Adults 18-55 years of age at the time of signing the informed consent form with... [+3]

Very mild tinnitus (THI values <12); [+7]

Status: Recruiting

Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters. Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).

Participants needed: 116
Trial details
Age: 18-55Biological sex: AllType: InterventionalSponsor: Restorear Devices LLCUpdated: Apr 2, 2025Locations: 1
Eligibility criteria

Adults aged 18-55 years old at the time of signing the consent form [+1]

Abnormal tympanometric findings [+7]

Status: Recruiting

Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation? Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

Participants needed: 54
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Restorear Devices LLCUpdated: Nov 21, 2024Locations: 1
Eligibility criteria

Advanced Bionics (FDA indications - severe to profound sensorineural hearing los... [+12]