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Peripheral Nerve Stimulation (PNS) to optimize military performance during and after sleep deprivation

Peripheral Nerve Stimulation (PNS) to optimize military performance during and after sleep deprivation - Peripheral Nerve Stimulation and Sleep Deprivation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53207
Enrollment
40
Registered
2023-08-28
Start date
2023-10-02
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menselijk presteren Human performance increasing alertness

Interventions

Both groups will undergo one night of SD, with one group receiving ctVNS and the second group receiving sham stimulation. Electrical stimulation at 25 Hz is applied twice for 2 minutes in the neck u

Sponsors

TNO
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. The potential subject has given informed and written consent and is able to comply with all study assessments scheduled in the protocol. 2. All subjects need to be between 18 and 55 years of age. 3. All subjects have computer skills. 4. All subjects declare to be in good health, and declare not to have any chronic diseases. 5. Subjects must be able to communicate, participate, and comply with the requirements of the entire study. 6. One week prior to starting every trial day, all subjects need to be (and remain) in the same time zone as the CET time zone in which the research center lies. (GMT+1, daylight savings GMT+2). This to exclude jet lags which may confound the test results. 7. No signs of flue or viral infection in the last 5 days before the start. 8. Participant is active military personnel

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Pregnancy 2. Atherosclerosis 3. Other cardiovascular health issues 4. Epilepsy and a history of psychiatric illness (including sleeping disorders). 5. Having an active implantable (metallic) device. 6. Using another device at the same time of testing or any portable electronic device (e.g., mobile phone). 7. Used alcohol the day before the start of a test day. 8. Used drugs in the last 3 months.

Design outcomes

Primary

MeasureTime frame
Cognitive performance on the cognitive task battery (e.g., reaction time, false alarms, lapses)

Secondary

MeasureTime frame
- VR test, including the percentage of decisions properly made as measured with a checklist for video-analysis. Quality of performance is also graded by instructors who are present during the VR test. - Sleepiness levels after each cognitive performance test - Mood ratings (pre- and post tests) - Positive- and Negative affect ratings (pre- and post tests) - Mental effort ratings after each cognitive performance test - Symptoms of motion sickness after the VR test

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)