TinnitusNCT06776705
Low-intensity TUS for Sleep Disturbances in Patients With Chronic Tinnitus
A study testing Low-intensity transcranial ultrasound stimulation in people with Tinnitus and Sleep Disturbances, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Tinnitus, Sleep Disturbances, Cognition
- What is being tested?
- Low-intensity transcranial ultrasound stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesHong Kong
- Study dates
- 15 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese, right-handed, aged from 60 to 80 years.
- Chronic tinnitus is defined as tinnitus with a duration of at least 3 months. Depending on the justification, different time course definitions of chronic tinnitus are possible.
- Sleep disturbances are defined as a Pittsburgh Sleep Quality Index (PSQI) total score above 5.
- No interference with independence in everyday activities.
Who cannot join
- Diseases of ear canal and tympanic membrane checked by otoscopic examination.
- Previous diagnosis of Meniere's disease and acoustic neuromas.
- Past history of neurological or mental disorders.
- Physically frail affecting attendance to treatment sessions.
- Already attending regular treatments, such as cognitive behavioral therapy or music therapy.
- Taking a psychotropic or other medication known to affect hearing functions.
- Significant communicative impairments.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Tai Po Hospital
Hong Kong, Hong Kong, 100000
Xi NI, PhD, xini@cuhk.edu.hk
- Recruiting
Tai Po Hospital
Hong Kong, Tai Po District, 100000
Hanna LU, PhD, 85228314305, hannalu@cuhk.edu.hk
Hanna, PhD
About this study
Official title: A Pilot Randomized Controlled Trial of MRI-guided Focused Low-intensity Transcranial Ultrasound Stimulation (TUS) for Sleep Disturbances in Patients With Chronic Tinnitus
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.
Read the detailed description
Significance: This study aims to investigate the feasibility, safety and efficacy of low intensity TUS for sleep disturbances in patients with tinnitus. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechnology. Information will be helpful for in-depth understanding the relationship of "tinnitus, sleep and cognition" and guiding the further studies of otology, sleep medicine and age-related neurodegenerative diseases.
Data analysis: The primary outcomes will be the changes in tinnitus symptoms and sleep quality, and the comparisons of group differences across different time points. Secondary outcomes will be the changes of cognitive functions and quality of life. Intention-to-treat analysis will be carried out. Changes of efficacy indicators from baseline to each follow up point will be tested with mixed effect model.
- Conditions
- Tinnitus, Sleep Disturbances, Cognition
- Being tested
- Low-intensity transcranial ultrasound stimulation
- Keywords
- Tinnitus, Cognitive Dysfunction, Sleep distubances, Transcranial ultrasound stimulation, Hippocampus, Complex attention, Simulation, Central Nervous System Diseases
- Medical subject headings
- Tinnitus, Parasomnias, Cognitive Dysfunction, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity transcranial ultrasound stimulationDevice
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
| Study group | Role | What they receive |
|---|---|---|
| Active TUS | Active comparator | In active TUS group, participants will receive 500 kHz low-intensity TUS. Receives: Device: Low-intensity transcranial ultrasound stimulation |
| Sham TUS | Sham comparator | In sham TUS group, participants will not receive low-intensity TUS. Receives: Device: Low-intensity transcranial ultrasound stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Primary Functions Questionnaire (TPFQ)
A short 12-item version of TPFQ is used in this study. In the 12-item version, questions 7, 11, and 15 were chosen for concentration; questions 4, 8, and 10 were chosen for emotion; questions 2, 14, and 17 were chosen for hearing; and questions 16, 18, and 20 were chosen for sleep.
Measured: 12 weeks
Pittsburg Sleep Quality Index (PSQI)
The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%)(Buysse et al., 1988). Greater score of PSQI indicates worse sleep quality.
Measured: 12 weeks
Secondary outcomes (3)
Tinnitus Handicap Inventory (THI)
THI is used to identify, quantify and evaluate the difficulties that patients with chronic tinnitus may experience in daily life. There are 25 items covering three aspects: functional, emotional and catastrophic. The THI score ranges from 0 to 100, with higher scores indicating more severe tinnitus burden and a seven-point change representing a minimal clinically important difference.
Measured: 12 weeks
Attention network test (ANT)
Complex attention is measured by ANT. Within ANT paradigm, there are four types of cues: no cue, center cue, double cue, and spatial cue; and three types of flankers: neutral, congruent, and incongruent. In a given trial, a central cross-fixation point presents 400 to 1,600 ms (randomized), subsequently is replaced for 100 ms by one of four warning cues. The target, a central arrow, could appear above or below the cross-fixation and is surrounded by two flankers on each side.
Measured: 12 weeks
Word-list learning test (WLLT)
WLLT, consisting of ten semantically non-associated words that is presented consecutively over three free trials of immediate recall, a 20-min delayed recall (to prevent recency effects).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start15 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LU Hanna, Chinese University of Hong Kong
- Investigators
- Hanna LU, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776705
- Sponsor's protocol ID
- 2023.636
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected in this study may include the healthy information and medical records.
Publications
Ni X, Yuen YS, Li Z, Wang K, Yang NS, Yuan Y, Meng L, Guo L, Lu H. 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. PLoS One. 2025 Aug 6;20(8):e0329950. doi: 10.1371/journal.pone.0329950. eCollection 2025.
PubMed 40768410
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of MRI-guided Focused Low-intensity Transcranial Ultrasound Stimulation (TUS) for Sleep Disturbances in Patients With Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT06776705
- Acronym / sponsor ID
- 2023.636
- Conditions
- Tinnitus, Sleep Disturbances, Cognition
- Keywords
- Tinnitus, Cognitive Dysfunction, Sleep distubances, Transcranial ultrasound stimulation, Hippocampus, Complex attention, Simulation, Central Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Significance: This study aims to investigate the feasibility, safety and efficacy of low intensity TUS for sleep disturbances in patients with tinnitus. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechnology. Information will be helpful for in-depth understanding the relationship of "tinnitus, sleep and cognition" and guiding the further studies of otology, sleep medicine and age-related neurodegenerative diseases.
Data analysis: The primary outcomes will be the changes in tinnitus symptoms and sleep quality, and the comparisons of group differences across different time points. Secondary outcomes will be the changes of cognitive functions and quality of life. Intention-to-treat analysis will be carried out. Changes of efficacy indicators from baseline to each follow up point will be tested with mixed effect model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TUS | Active comparator | Device: Low-intensity transcranial ultrasound stimulationIn active TUS group, participants will receive 500 kHz low-intensity TUS. |
| Sham TUS | Sham comparator | Device: Low-intensity transcranial ultrasound stimulationIn sham TUS group, participants will not receive low-intensity TUS. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chinese, right-handed, aged from 60 to 80 years.
- Chronic tinnitus is defined as tinnitus with a duration of at least 3 months. Depending on the justification, different time course definitions of chronic tinnitus are possible.
- Sleep disturbances are defined as a Pittsburgh Sleep Quality Index (PSQI) total score above 5.
- No interference with independence in everyday activities.
Key exclusion criteria (7 listed)
- Diseases of ear canal and tympanic membrane checked by otoscopic examination.
- Previous diagnosis of Meniere's disease and acoustic neuromas.
- Past history of neurological or mental disorders.
- Physically frail affecting attendance to treatment sessions.
- Already attending regular treatments, such as cognitive behavioral therapy or music therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity transcranial ultrasound stimulationLow-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency. | Device | Active TUS, Sham TUS |
Primary outcome
Tinnitus Primary Functions Questionnaire (TPFQ)
Time frame: 12 weeks
A short 12-item version of TPFQ is used in this study. In the 12-item version, questions 7, 11, and 15 were chosen for concentration; questions 4, 8, and 10 were chosen for emotion; questions 2, 14, and 17 were chosen for hearing; and questions 16, 18, and 20 were chosen for sleep.
Pittsburg Sleep Quality Index (PSQI)
Time frame: 12 weeks
The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%)(Buysse et al., 1988). Greater score of PSQI indicates worse sleep quality.
3 secondary outcomes
Tinnitus Handicap Inventory (THI)
Time frame: 12 weeks
Attention network test (ANT)
Time frame: 12 weeks
Word-list learning test (WLLT)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 40768410Ni X, Yuen YS, Li Z, Wang K, Yang NS, Yuan Y, Meng L, Guo L, Lu H. 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. PLoS One. 2025 Aug 6;20(8):e0329950. doi: 10.1371/journal.pone.0329950. eCollection 2025.
- Individual participant dataSharing planned: No. The data collected in this study may include the healthy information and medical records.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hanna LU, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity transcranial ultrasound stimulation in people with Tinnitus and Sleep Disturbances, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Ni, PhD (852-28314305, xini@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Primary Functions Questionnaire (TPFQ) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.