NCT04110717

Brief Summary

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification programme, as a means of reducing excess body weight and body fat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

October 9, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

September 29, 2019

Last Update Submit

March 29, 2023

Conditions

OverweightObesityOverweight and ObesityOverweight or ObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Total body weight loss

    In kg

    12 weeks

Study Arms (2)

Active Device Group

EXPERIMENTAL

25 subjects randomised to receive active device use plus lifestyle intervention for 3 months.

Device: Vestal DeviceBehavioral: Hypocaloric Diet

Control Device Group

PLACEBO COMPARATOR

25 subjects randomised to receive control device use plus lifestyle intervention for 3 months.

Device: Control DeviceBehavioral: Hypocaloric Diet

Interventions

Vestal DeviceDEVICE

Vestibular nerve stimulator

Active Device Group
Control DeviceDEVICE

Control Device

Control Device Group
Hypocaloric DietBEHAVIORAL

Hypocaloric diet

Active Device GroupControl Device Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Body mass index (BMI) ≥ 25 kg/m2 2. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test They should agree to follow a physician-approved contraceptive regimen for the duration of the study period (other than DMPA injections as this causes weight gain).
  • \. 18-80 years of age inclusive on starting the study. 4. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
  • \. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
  • \. Agreement not to start smoking tobacco or marijuana for the duration of the study.
  • \. Access to Wi-Fi (to connect iPod to internet)

You may not qualify if:

  • \. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
  • \. History of bariatric surgery, or gastric resection. 3. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
  • \. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti). 5. Use of a non-invasive weight loss device (e.g. Modius) 6. Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
  • \. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly) 8. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
  • \. Diagnosis of cirrhosis, chronic pancreatitis, or liver, kidney or heart failure.
  • \. Treatment with prescription weight-loss drug therapy in the 6 months before starting the study.
  • \. Tobacco or marijuana smoking in the 6 months before starting and for the duration of the study.
  • \. Known genetic cause of obesity (e.g., Prader-Willi Syndrome). 13. Body weight change of more than 20% in either direction within the previous year.
  • \. Physician-prescribed diet, and/ or current, active member of an organized weight loss program.
  • \. Diabetes mellitus (Types 1 \& 2). 16. Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy) 17. Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last 6 months.
  • \. Regular use (more than twice a month) of anti-histamine medication within the last 6 months.
  • \. Use of oral or intravenous corticosteroid medication within 6 months of starting the study.
  • \. Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
  • \. Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
  • \. An active diagnosis of cancer. 23. A myocardial infarction within the preceding year. 24. A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

Location

MeSH Terms

Conditions

OverweightObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 1, 2019

Study Start

October 9, 2020

Primary Completion

March 23, 2021

Study Completion

March 23, 2021

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)