Insomnia Clinical Trial
Official title:
Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores
NCT number | NCT04219566 |
Other study ID # | IVS001S |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | July 31, 2022 |
Verified date | October 2022 |
Source | Neurovalens Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 80 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 24 Years |
Eligibility | Inclusion Criteria: - Adults - Both genders - Ages 18-24 years inclusive - Score above 14 in the insomnia severity index questionnaire - Willingness to participate in the study. Exclusion Criteria: - Use sleep medication - Ear problems - Under any kind of treatment - Practicing sleep improving techniques - Any other significant health-related problems. |
Country | Name | City | State |
---|---|---|---|
India | RD Gardi Medical College | Ujjain | Madhya Pradesh |
Lead Sponsor | Collaborator |
---|---|
Neurovalens Ltd. | Compliance Solutions Ltd., RD Gardi Medical College |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | EEG Assessment | EEG power in alpha band | Day 0, Day 28 | |
Secondary | 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. | Day 0, Day 7, Day 14, Day 21, Day 28 | |
Secondary | 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 |
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