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出境医 / 临床实验 / Non-invasive Nerve Stimulation and Sleep (NINS)
Non-invasive Nerve Stimulation and Sleep (NINS)
Study Description
Brief Summary:
People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PTSD | Device: non-invasive nerve stimulation | Phase 1 Phase 2 |
Detailed Description:
People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | The study is a cross-over design comparing two stimulation locations. The order of stimulation is randomly assigned. |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | The investigators are using a blinding box with a code entry system that determines which stimulation location is used. The study coordinator/care providers will know the code, but not the stimulation location. Participants will know the stimulation location (they can feel it) but not which location is the investigators' hypothesized actor (i.e., they don't which is sham and which is target). The investigators will not know which is which until the data are in analyzable form. |
| Primary Purpose: | Treatment |
| Official Title: | Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI |
| Actual Study Start Date : | January 30, 2020 |
| Estimated Primary Completion Date : | September 30, 2023 |
| Estimated Study Completion Date : | September 30, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: non-invasive nerve stimulation a
Electrical stimulation will be delivered to a location at the ear.
|
Device: non-invasive nerve stimulation
Electrical stimulation will be provided via a TENS unit.
|
|
Active Comparator: non-invasive nerve stimulation b
Electrical stimulation will be delivered to a location at the ear.
|
Device: non-invasive nerve stimulation
Electrical stimulation will be provided via a TENS unit.
|
Outcome Measures
Primary Outcome Measures :
- Polysomnography [ Time Frame: One night comparison ]Polysomnography measures sleep architecture.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
- English fluency
Exclusion Criteria:
- Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study
-
Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the
- e.g., schizophrenia
-
Untreated sleep apnea
- CPAP controlled sleep apnea is okay
- Major uncorrected sensory deficit
-
Current drug or alcohol abuse
- Drug abuse within the last two months will result in exclusion or delay
- Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable
- No pregnancy
Contacts and Locations
Contacts
| Contact: John B Williamson, PhD | (352) 376-1611 | john.williamson2@va.gov | |
| Contact: Richard B Berry, MD | (352) 376-1611 ext 106241 | richard.berry@va.gov |
Locations
| United States, Florida | |
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Stephen E Nadeau, MD BS BS 352-548-6551 Stephen.Nadeau@va.gov | |
| Contact: Russell M Bauer, PhD rbauer@phhp.ufl.edu | |
| Principal Investigator: John B. Williamson, PhD | |
Sponsors and Collaborators
VA Office of Research and Development
Investigators
| Principal Investigator: | John B. Williamson, PhD | North Florida/South Georgia Veterans Health System, Gainesville, FL |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||||||
| First Posted Date ICMJE | July 16, 2019 | ||||||||
| Last Update Posted Date | January 22, 2021 | ||||||||
| Actual Study Start Date ICMJE | January 30, 2020 | ||||||||
| Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Polysomnography [ Time Frame: One night comparison ] Polysomnography measures sleep architecture.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Non-invasive Nerve Stimulation and Sleep | ||||||||
| Official Title ICMJE | Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI | ||||||||
| Brief Summary | People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved. | ||||||||
| Detailed Description | People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 Phase 2 |
||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: The study is a cross-over design comparing two stimulation locations. The order of stimulation is randomly assigned. Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The investigators are using a blinding box with a code entry system that determines which stimulation location is used. The study coordinator/care providers will know the code, but not the stimulation location. Participants will know the stimulation location (they can feel it) but not which location is the investigators' hypothesized actor (i.e., they don't which is sham and which is target). The investigators will not know which is which until the data are in analyzable form. Primary Purpose: Treatment
|
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| Condition ICMJE | PTSD | ||||||||
| Intervention ICMJE | Device: non-invasive nerve stimulation
Electrical stimulation will be provided via a TENS unit.
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
104 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 30, 2023 | ||||||||
| Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04021537 | ||||||||
| Other Study ID Numbers ICMJE | N3140-R 1RX003140A ( Other Grant/Funding Number: Dept of Veterans Affairs ) |
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| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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