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NCT06776705
Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus
NA trial testing Low-intensity transcranial ultrasound stimulation in Tinnitus in 14 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 15 January 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 2 locations across Hong Kong |
Drugs / interventions tested
- Low-intensity transcranial ultrasound stimulation
Conditions studied
- Tinnitus — all drugs for Tinnitus →
- Sleep Disturbances — all drugs for Sleep Disturbances →
- Cognition — all drugs for Cognition →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 60 to 85, any sex, with Tinnitus or Sleep Disturbances. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Tinnitus, as a common symptom, can jeopardize the sleep quality and brain function and even lead to hearing loss and cognitive decline in elderly patients. The co-occurring tinnitus and sleep disturbances can significantly affect the cognitive functions and quality of life, and even be implicated as a key contributing factor in the development of prodromal dementia. At present, very few non-pharmacological therapies are developed for managing these comorbidities in elderly patients. Focused low-intensity transcranial ultrasound stimulation (TUS) enables to stimulation the deep brain structures, such as hippocampus, with optimized focality and specific frequency. Objectives: We aim to 1) investigate the safety, feasibility and efficacy of a 2-week focused low-intensity TUS on the severity of tinnitus and sleep disturbances in elderly patients; 2) determine the sample size of a full-scale randomized clinical trial of low-intensity TUS in patients with tinnitus; 3) evaluate the effects of low-intensity TUS on the severity of tinnitus, sleep quality and cognitive functions at 2, 4 and 6 weeks after the treatments. Design: A 2-week randomized, double-blind, controlled clinical trial. Methods: Chinese right-handed tinnitus patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either low intensity TUS or sham TUS, with 7 participants per arm. Before intervention, T1-weighted magnetic resonance imaging (MRI) and diffusion-weighted imaging (DWI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and quality of life will be conducted at baseline, 2nd week, 4th week and 6th week. Program adherence and adverse effects will be monitored throughout intervention.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Focused low-intensity hippocampal transcranial ultrasound stimulation (TUS) for sleep disturbances in patients with chronic tinnitus: A study protocol for a pilot randomized controlled trial.
Ni X, Yuen YS, Li Z, Wang K, et al · · 2025 · cited 2× · PMID 40768410 · DOI 10.1371/journal.pone.0329950
Verify or expand the search:
- PubMed search for NCT06776705
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Low-intensity transcranial ultrasound stimulation
Trials testing the same drug.
- NCT07298876 — Low-intensity Hippocampal Transcranial Ultrasound Stimulation for Managing Cognitive and Sleep Dysfunction in Preclinica · NA · enrolling by invitation
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
- NCT07017998 — External Therapy for Tinnitus Management · NA · recruiting
Other Chinese University of Hong Kong trials
Trials by the same sponsor.
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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 NCT06776705 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 18 July 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/NCT06776705.
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