NCT02882880

Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Luco Hybrid OSA Appliance Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

51 subjects were selected and separated into two groups: those new to the treatment (Group 1)and those who had been in treatment for more than 1 year (Group 2). There were 32 participants in group 1 and 19 in group 2. mean age for Group 1 was 41.7 and Group 2 was 50.5. The age range for Group 1 was 21 to 66 and in Group 2 34 to 73. Group 1 subjects were fitted with a Luco hybrid OSA appliance (LHOA). They were followed over a 14 day period with adjustments made to the device as required. The second study \[milestone\] was completed at that time. Group 2 subjects, who had previously been in treatment with the device for and mean of 4.1 years, had an initial study with the device and a second study following 48 hours without the device. Both groups were studied again at 60 days and results compared.

Conditions

• Sleep Bruxism
• Tension Headache
• Migraine Headache

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2016-08-30
• Last updated: 2021-02-18

Locations

1 site across 1 country: Canada