Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance (LucoHybrid)

Luco Hybrid OSA Appliance

Status: Completed

Conditions: Tension Headache; Migraine Headache; Sleep Bruxism

Treatments: Device: The Luco Hybrid OSA Appliance

Study type: Interventional

Funder types: Industry

Identifiers

NCT02882880

Lucohybridosa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Started

Other group

Description:

Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours

Treatment:

Device: The Luco Hybrid OSA Appliance

Completed

Active Comparator group

Description:

Intervention: The LUco Hybrid OSA APpliance The subjects that actually completed the study in both groups. Group 1 n = 32, in Group 2 n=19

Treatment:

Device: The Luco Hybrid OSA Appliance