Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

NCT02882880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2021-02-18

No results posted yet for this study

Summary

To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.

Conditions

  • Sleep Bruxism
  • Tension Headache
  • Migraine Headache

Interventions

DEVICE

The Luco Hybrid OSA Appliance

Group 1, initial treatment with the device, reassessed at 14 and 60 days, Group 2, removal of the treatment for 48 hours, to determine if relapse occurs, retested at 60 days with the device (recovery from intervention).

Sponsors & Collaborators

  • Luco Hybrid OSA Appliance Inc.

    lead INDUSTRY

Principal Investigators

  • Ken J Luco, DDS, BSc · Luco Hybrid OSA Appliance Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882880 on ClinicalTrials.gov