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NCT03859336 · ClinicalTrials.gov registry record · NA
High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD
A NA study, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03859336: Completed NA study, sponsored by Phoenix Children's Hospital.
NCT03859336 is a NA study that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859336, a NA study, has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
The objective of this study is to investigate the feasibility of cervical TEN stimulation (TENS) delivered to the back of the neck to decrease anxiety and sleep issues in young adults with Autism Spectrum Disorder (ASD). The specific aim is to determine the effect of TENS, delivered over 3 daily sessions, on anxiety and sleep quality in young adults with ASD, as compared to sham and baseline. The investigator will enroll up to 10 young adults, aged 10 to 25 years of age with confirmed ASD and measureable anxiety and sleep disturbance symptoms, and participation will last 3 weeks.
Primary Outcome
The standard deviation of the normal-to-normal heart beat (SDNN) is the time-domain based measured of heart rate variability. It is measured by calculating the standard deviation of the heart beat-to-beat time interval, which is measured in milliseconds. Anxiety reduction will be demonstrated by a reduction in the SDNN value during a stressor in response to TEN treatment, as compared to baseline.
Interventions
- DEVICE Transdermal Neuromodulation Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-05-21 |
| Est. Completion | 2021-10-06 |
| Phase | NA |
What the finished NCT03859336 record still lists
NCT03859336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Transdermal Neuromodulation Stimulation is the first listed.
NCT03859336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859336 about?
NCT03859336 is a clinical study titled "High-Frequency Transdermal Neuromodulation to Decrease Anxiety and Improve Sleep in ASD". The objective of this study is to investigate the feasibility of cervical TEN stimulation (TENS) delivered to the back of the neck to decrease anxiety and sleep issues in young adults with Autism Spectrum Disorder (ASD). The specific aim is to determine the effect of TENS, delivered over 3 daily ses...
What is the current status of trial NCT03859336?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-05-21. Estimated completion is 2021-10-06.
What interventions are being tested in trial NCT03859336?
The interventions under investigation include: Transdermal Neuromodulation Stimulation (DEVICE).
Who is sponsoring clinical trial NCT03859336?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03859336's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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