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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000152426
Ethics application status
Approved
Date submitted
28/01/2025
Date registered
10/02/2025
Date last updated
10/02/2025
Date data sharing statement initially provided
10/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Vagus nerve stimulation for tinnitus
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Scientific title
Paired vagus nerve and auditory stimulation for the treatment of tinnitus: a proof-of-concept and feasibility study
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Secondary ID [1]
313824
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tinnitus
336467
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Condition category
Condition code
Neurological
332982
332982
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Non-invasive vagus nerve stimulation (VNS) will be applied in conjunction with auditory stimulus. The intervention will be administered three times a week (30 minutes per session) for 3 weeks (9 sessions in total) using the DualSTIM multi-modal stimulator. The three sessions will not occur on three consecutive days; however, two days in a row will be allowed depending on the participants' schedules. Participants will fill out dated surveys when arriving for each session so session dates and attendance will be recorded.
The DualSTIM will electrically stimulate the auricular branch of the vagus nerve using small electrodes that clip to the tragus. It also features a headphone port for audio output. The auditory stimulus will be a tone generated to match a participant's tinnitus percept at each first session by a trained research assistant. Future sessions will also be managed by the same research assistant at a quiet room within Dunedin Hospital.
Participants in the treatment groups will receive 1 second of VNS that is paired with 3 seconds of auditory stimulation (either simultaneously or with a 5 second delay). This will occur repeatedly every 15-20 seconds throughout each 30-minute treatment session. These 15-20 second stimulation periods will have random lengths.
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Intervention code [1]
330411
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Treatment: Devices
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Comparator / control treatment
Participants in the control group will receive randomized desynchronized VNS and auditory stimulation. The same 1 second of VNS will occur at the start of each 15-20 second stimulation period. However, the 3 seconds of auditory stimulation will occur at a random time within each stimulation period (so delay could range from 0 to 17 seconds) in order to prevent a strong learning association.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recruitment rate
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Assessment method [1]
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Recruitment rate (i.e. the number of participants recruited per month, until the proposed sample size is reached). The recruitment rate will be recorded by the CI every week after the release of the advertisements and the number of advertisements will also be recorded. The proportion of participants recruited from the total number screened (with reasons for exclusion) will also be recorded and expressed as a percentage. This will be sourced from auditing study recruitment records.
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Timepoint [1]
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End of treatment, end of follow-up stage
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Primary outcome [2]
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Safety
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Assessment method [2]
340522
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Qualitative description of any symptom The intensity of each symptom will be measured using a Likert scale ranging from 0 (none) to 10 (extreme) Relation of the symptom to the treatment, measured on a scale ranging from 1 (unrelated) to 5 (strongly related). Duration of each symptom and the time taken for resolution of each symptom, expressed in minutes. Any drop-outs due to adverse effects will also be recorded Non-invasive vagus nerve stimulation is well-tolerated but electrical stimulation may cause redness, tingling, or itching Effects which happen during invasive vagus nerve stimulation are possible but unlikely: these include coughing, pain, and paresthesia
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Timepoint [2]
340522
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Whenever adverse effects occur during the 3-week study period
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Primary outcome [3]
340523
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Tinnitus loudness
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Assessment method [3]
340523
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Numeric ratings for tinnitus loudness will be recorded on an 11-point scale from 0 to 10
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Timepoint [3]
340523
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Before and after each treatment session
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Secondary outcome [1]
444330
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Tinnitus disability
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Assessment method [1]
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Tinnitus Functional Index
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Timepoint [1]
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Before treatment period, after treatment period, at 1-month follow-up
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Secondary outcome [2]
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Sleep quality
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Assessment method [2]
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Pittsburgh Sleep Quality Index
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Timepoint [2]
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Before and after treatment period
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Secondary outcome [3]
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Patient-described treatment efficacy
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Assessment method [3]
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Patients' Global Impression of Change
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Timepoint [3]
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End of each week of treatment (3 times) At 1-month follow-up
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Secondary outcome [4]
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Depression
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Assessment method [4]
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Depression Anxiety Stress Scale-21 (DASS-21) depression subscale score
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Timepoint [4]
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Before and after treatment period
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Secondary outcome [5]
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Adherence to intervention - this is an additional primary outcome
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Assessment method [5]
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Calculated as the number of treatment sessions attended by each participant and expressed as a percentage of the total number of sessions. Adherence rates will be calculated once the treatment phase is completed by auditing the dated surveys filled out by each participant
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Timepoint [5]
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After the 3-week treatment period
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Secondary outcome [6]
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Tinnitus distress - this is an additional primary outcome
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Assessment method [6]
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Numeric ratings for tinnitus distress will be recorded on an 11-point scale from 0 to 10
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Timepoint [6]
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Before and after each treatment session
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Secondary outcome [7]
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Tinnitus unpleasantness - this is an additional primary outcome
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Assessment method [7]
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Numeric ratings for tinnitus unpleasantness will be recorded on an 11-point scale from 0 to 10
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Timepoint [7]
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Before and after each treatment session
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Secondary outcome [8]
444521
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Drop-out rates - this is an additional primary outcome
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Assessment method [8]
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Measured as the number of participants who dropped-out in each group and expressed as a percentage of the total number of participants enrolled in the study. This will be calculated by auditing study recruitment and drop-out records
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Timepoint [8]
444521
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After the 1-month follow-up phase is completed
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Secondary outcome [9]
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Participant satisfaction levels - this is an additional primary outcome
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Assessment method [9]
444522
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Participant satisfaction regarding treatment and the acceptability of the VNS will be recorded on an 11-point numeric rating scale (0 - not at all satisfied / acceptable to 10 - very satisfied / acceptable).
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Timepoint [9]
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At the 1-month follow-up for each participant
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Secondary outcome [10]
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Anxiety
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Assessment method [10]
444523
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Depression Anxiety Stress Scale-21 (DASS-21) anxiety subscale score
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Timepoint [10]
444523
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Before and after treatment period
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Secondary outcome [11]
444524
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Stress
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Assessment method [11]
444524
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Depression Anxiety Stress Scale-21 (DASS-21) stress subscale score
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Timepoint [11]
444524
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Before and after treatment period
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Eligibility
Key inclusion criteria
Diagnosis of chronic, pure-tone tinnitus
Tinnitus loudness of 4 or higher on a numeric rating scale
Capable of understanding the study information and able to sign the informed consent form
Age above 18 years on the day of the consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
History of neurological diseases
History of epilepsy or seizures
Current substance use disorders
Cognitive impairments (dementia, Alzheimer’s disease, personality disorders, substance use disorders, certain medical conditions): a total score of 24 or below on Mini-Mental State Examination
Presence of any pacemaker or defibrillator
Presence of any electronic implants or metal implant in the body (particularly head and neck)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by computer software
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/02/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26847
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New Zealand
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State/province [1]
26847
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Funding & Sponsors
Funding source category [1]
318294
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University
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Name [1]
318294
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University of Otago
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Address [1]
318294
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Country [1]
318294
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
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Country
New Zealand
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Secondary sponsor category [1]
320678
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None
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Name [1]
320678
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Address [1]
320678
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Country [1]
320678
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316933
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Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
316933
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https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
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Ethics committee country [1]
316933
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New Zealand
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Date submitted for ethics approval [1]
316933
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Approval date [1]
316933
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22/11/2024
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Ethics approval number [1]
316933
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Summary
Brief summary
Tinnitus is a significant and growing health challenge globally, affecting individuals, their whanau, the wider community, and the healthcare system. Current treatments are ineffective and or are often associated with adverse effects. New innovative safer therapies are thus warranted. Our study will explore and test the effect of a novel approach pairing vagus nerve stimulation (VNS) and sound stimulation. The VNS has shown to activate the parasympathetic ‘rest-digest-restore’ response. If the sound stimulation is given immediately after the VNS (i.e., during the parasympathetic activation phase), it would potentially remove the salience attached to an otherwise meaningless tinnitus sound; thus resulting in improved clinical outcomes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Dirk De Ridder
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Address
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Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56, Dunedin 9054, New Zealand
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Country
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New Zealand
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Phone
139470
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+64275601144
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Fax
139470
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Email
139470
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[email protected]
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Contact person for public queries
Name
139471
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Dr. Divya Adhia
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Address
139471
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Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56, Dunedin 9054, New Zealand
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Country
139471
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New Zealand
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Phone
139471
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+64211167594
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Fax
139471
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Email
139471
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[email protected]
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Contact person for scientific queries
Name
139472
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Dr. Divya Adhia
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Address
139472
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Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56, Dunedin 9054, New Zealand
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Country
139472
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New Zealand
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Phone
139472
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+64211167594
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Fax
139472
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Email
139472
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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