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NCT07017998
External Therapy for Tinnitus Management
NA trial testing Cold pack-delivered mild therapeutic hypothermia in Tinnitus in 80 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Restorear Devices LLC |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 16 July 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cold pack-delivered mild therapeutic hypothermia
- Sham (No Treatment) — full drug profile →
Conditions studied
- Tinnitus — all drugs for Tinnitus →
- Tinnitus, Subjective — all drugs for Tinnitus, Subjective →
Sponsor
Restorear Devices LLC
Who can join
Adults 18 to 55, any sex, with Tinnitus or Tinnitus, Subjective. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07017998
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cold pack-delivered mild therapeutic hypothermia
Trials testing the same drug.
- NCT07071480 — Noninvasive Therapy for Tinnitus · NA · recruiting
- NCT06729632 — Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss · NA · recruiting
Other recruiting trials for Tinnitus
Currently open trials in the same condition.
- NCT07393880 — Bimodal Electrical-Sound Stimulation and Auditory Training for Chronic Tonal Tinnitus · NA · recruiting
- NCT07071480 — Noninvasive Therapy for Tinnitus · NA · recruiting
- NCT07435298 — Navigated Repetitive TMS for Chronic Tinnitus · NA · recruiting
- NCT07158034 — Investigating EEG as a Biomarker for Tinnitus Improvement After Bimodal Stimulation · NA · recruiting
- NCT07489807 — The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults · NA · recruiting
Other Restorear Devices LLC trials
Trials by the same sponsor.
- NCT07071480 — Noninvasive Therapy for Tinnitus · NA · recruiting
- NCT06729632 — Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss · NA · recruiting
- NCT06375278 — Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implan · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07017998 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Restorear Devices LLC
- Last refreshed: 17 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07017998.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing