Clinical trial NCT02882880: Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance
Official title: The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Bruxism
Tension Headache
Migraine Headache
Lead sponsor: Luco Hybrid OSA Appliance Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-30
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age (adult)
* capable of giving informed consent
* met the AASM criteria for sleep bruxism
* had sound dentition
* did not have active obstructive sleep apnea(OSA)/upper airway resistance syndrome (UARS)

Exclusion Criteria:

* younger than 18
* incapable of informed consent
* did not meet the AASM criteria for sleep bruxism
* discovered OSA or UARS in the initial study
* did not have sound dentition (active caries, periodontal disease, inadequate number of teeth
* had obstructive sleep apnea/UARS
* did not complete the study
* completed the study but did not complete all aspects of the study

Primary outcomes:
measure: Response to treatment with the Luco Hybrid OSA Appliance
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Dr. K. Luco Dentistry Professional Corporation
state: Ontario
Study officials:
affiliation: Luco Hybrid OSA Appliance Inc.
name: Ken J Luco, DDS, BSc
role: PRINCIPAL_INVESTIGATOR
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