Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance
NCT02882880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2021-02-18
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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