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NCT04627480

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Active, enrolled Phase 4 Last updated 14 January 2021
What this trial tests

Phase 4 trial testing Fisher Wallace Neurostimulation Device in Insomnia in 200 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 October 2020
Primary endpoint
31 January 2021
21 February 2021

Quick facts

Lead sponsorProofPilot
PhasePhase 4
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment200
Start date1 October 2020
Primary completion31 January 2021
Estimated completion21 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

ProofPilot

Who can join

21 and older, any sex, with Insomnia or Insomnia Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
    Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
  2. Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
    Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284

Verify or expand the search:

Other recruiting trials for Insomnia

Currently open trials in the same condition.

Other ProofPilot trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04627480.

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