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NCT03913494: SnooZeal-snore

Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Completed NA Last updated 6 April 2021
What this trial tests

NA trial testing Transoral Neurostimulation Device (Snoozeal) in Sleep Apnea, Obstructive in 48 participants. Completed in 20 February 2020.

Timeline
30 July 2019
Primary endpoint
20 February 2020
20 February 2020

Quick facts

Lead sponsorUniversity of California, San Diego
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment48
Start date30 July 2019
Primary completion20 February 2020
Estimated completion20 February 2020
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, San Diego

Who can join

Adults 18 to 65, any sex, with Sleep Apnea, Obstructive or Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep Disordered Breathing (SDB) is a spectrum of conditions spanning from Simple Snoring to Severe Sleep apnea. SDB has multiple underlying mechanisms. Some portion of patients have issues with upper airway dilator muscle control; and such patients may be amenable to upper airway muscle training exercises using neuromuscular stimulation techniques. The investigators and others have published on the topic of neuromyopathy in the upper airway, defining a subgroup of OSA patients who may be amenable to training exercises. Based on this background, the investigators seek to test the hypothesis that upper airway tongue muscle training using transoral surface neuromuscular electrical stimulation may have benefits to patients with Simple Snoring.

Publications & conference data

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

  1. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea.
    Nokes B, Baptista PM, de Apodaca PMR, Carrasco-Llatas M, et al · · 2023 · cited 9× · PMID 35624401 · DOI 10.1007/s11325-022-02644-9
  2. The impact of daytime transoral neuromuscular stimulation on upper airway physiology - A mechanistic clinical investigation.
    Nokes B, Schmickl CN, Brena R, Bosompra NN, et al · · 2022 · cited 5× · PMID 35748091 · DOI 10.14814/phy2.15360

Verify or expand the search:

Other recruiting trials for Sleep Apnea, Obstructive

Currently open trials in the same condition.

Other University of California, San Diego 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/NCT03913494.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing