At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
The Luco Hybrid OSA Appliancedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
In Brief
A clinical study evaluating The Luco Hybrid OSA Appliance for Sleep Bruxism and 2 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Bruxism, Tension Headache, Migraine Headache
CountriesCanada
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJul 2015
Primary CompletionJun 2016
Study CompletionJul 2016
First PostedAug 2016
TodayJul 2026
First PostedAug 30, 2016
Enrollment StartJul 1, 2015
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.8 years ago
Interventions
The Luco Hybrid OSA Appliancedevice
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).