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| Name | Class |
|---|---|
| RD Gardi Medical College | UNKNOWN |
| Compliance Solutions Ltd. | INDUSTRY |
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A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings
The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active VeNS | Active Comparator | The VeSTAL device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset. |
|
| Sham VeNS | Sham Comparator | The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeNS | Device | Non-invasive electrical vestibular nerve stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index (ISI) Scores | ISI scores will be measured during the study and will be compared to baseline readings taken prior to intervention. Insomnia Severity Index scores range from 0 to 28. Scores greater than 15 indicate clinical insomnia. | Day 0, Day 7, Day 14, Day 21, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| EEG Assessment | EEG power in alpha band | Day 0, Day 28 |
| Depression Anxiety Stress Scales (DASS) Assessment | DASS will be measured during the study and will be compared to baseline readings taken prior to intervention. DASS is scored from 0 to 42 with higher scores indicating more symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sai Sailesh | RD Gardi Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RD Gardi Medical College | Ujjain | Madhya Pradesh | 456001 | India |
Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
| Placebo device |
| Device |
Sham non-invasive electrical vestibular nerve stimulation |
|
| Day 0, Day 7, Day 14, Day 21, Day 28 |
| WHO Quality of Life (WHOQOL) Assessment | QOL will be measured during the study and will be compared to baseline readings taken prior to intervention. WHOQOL is scored from 0 to 100 with higher scores indicating a higher quality of life. | Day 0, Day 7, Day 14, Day 21, Day 28 |
| D001523 |
| Mental Disorders |
| D021081 | Chronobiology Disorders |
| D009784 | Occupational Diseases |