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NCT04627480
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Phase 4 trial testing Fisher Wallace Neurostimulation Device in Insomnia in 200 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2021
Quick facts
| Lead sponsor | ProofPilot |
|---|---|
| Phase | Phase 4 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 October 2020 |
| Primary completion | 31 January 2021 |
| Estimated completion | 21 February 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fisher Wallace Neurostimulation Device
Conditions studied
- Insomnia — all drugs for Insomnia →
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Sleep — all drugs for Sleep →
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):
-
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 -
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:
- PubMed search for NCT04627480
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia
Currently open trials in the same condition.
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- NCT07071324 — CF Wellness Program · NA · recruiting
- NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
- NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting
Other ProofPilot trials
Trials by the same sponsor.
- NCT04914533 — Luminance RED for Canker Sores · NA · withdrawn
- NCT04751864 — Brain Stimulation & Generalized Anxiety Study · Phase 4 · active not recruiting
- NCT04541563 — Fisher Wallace Neurostimulation & Depression Study · NA · active not recruiting
- NCT04471896 — Joovvin' for Your Skin Health Study · NA · completed
- NCT04245254 — GutMe!: IBS and Collagen Protein Powder an Interventional Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04627480 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ProofPilot
- Last refreshed: 14 January 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing